A cache of 29 million doses of AstraZeneca’s COVID-19 vaccine has been discovered by Italian authorities at Catalent’s fill-finish site near Rome, raising more questions about the company’s distribution shortfall in Europe.
Due to a packaging flaw, the Chinese territories of Hong Kong and Macao have suspended use of the Pfizer–BioNTech COVID-19 vaccine, resulting in nearly a 5% drop in shares for Fosun Pharma, which manufactures the shot in China.
Moderna CEO Stephane Bancel discussed the future of the company with Fintech Zoom, outlining plans to apply mRNA technology to a variety of vaccines and treatments.
The world case count stood at more than 124 million on Wednesday morning, with more than 2.7 million reported deaths, according to Johns Hopkins University’s COVID-19 dashboard.
Please read below for the latest updates. Daily COVID-19 tracker entries from Aug. 11 to Oct. 30 can be found here. Entries from April 21 through Aug. 11 are here. Entries from Jan. 30 through April 20 are here.
UPDATED: Wednesday, March 24 at 10:54 p.m.
Authorities in Italy have found 29 million doses of AstraZeneca COVID-19 vaccine stockpiled at a Catalent fill-finish facility in Anagni. The discovery was made after the European Union noticed a discrepancy between supply outputs reported by the company and the individual manufacturing facilities. According to the Daily La Stampa, some of the discovered doses were produced by Halix in the Netherlands. The EU has been at odds with AZ over the company’s failure to deliver on its promised 100 million vaccine doses in the first quarter. To date, Europe has received just 16.6 million doses as vaccination rates lag far behind those of the United States and the UK.
The Chinese territories of Hong Kong and Macao have suspended use of the Pfizer–BioNTech COVID-19 vaccine because of a packaging flaw – a vial cap defect. Fosun Pharma, which manufactures and distributes the shot in China, is investigating along with BioNTech. Of 585,000 doses in the batch in question, 150,000 vaccines have been distributed. A subsequent batch of 758,000 doses has been put on hold. Officials don’t believe there is a safety issue, but have suspended us of the vaccine as a precaution. Both territories received their first shots a month ago. With the news, Fosun’s shares tumbled by nearly 5%.
With Moderna bringing its first product to market – a COVID-19 vaccine – this has been a transformational year for the company and its sudden-billionaire CEO Stephane Bancel, who told Fintech Zoom, “In 2021 and 2022 Moderna is going to scale at a pace that has never happened before in biotech.” Bancel discussed the future for the company and mRNA technology, which includes developing more COVID vaccines, a better flu shot and new ways to treat cancer and heart disease.
Australia is distributing its first batch of domestically produced COVID-19 vaccines. CSL Seqirus’ fill-finish site in Melbourne released 830,000 doses of the AstraZeneca shot. In cold storage are 2.5 million doses undergoing final testing before their release. Manufacture of bulk substance began in November at CSL Behring’s site in Broadmeadows.
U.S. regulators have cleared a Catalent plant in Bloomington, Indiana, to produce the single-shot COVID-19 vaccine for Johnson & Johnson. The approval will allow J&J to dramatically bump up production. The company pledged 20 million doses to the U.S. by the end of March, but has delivered only 4.5 million. Story
Researchers at Michigan Medicine have found a link between flu shots and the coronavirus. Of 27,000 patients, none tested positive for both viruses at the same time. Those who received flu shots were slightly less likely to contract the coronavirus, but were significantly less likely to develop severe cases of the disease.
In a pandemic-riddled year, German biopharmaceutical firm Boehringer Ingelheim accelerated efforts to research COVID-19 related therapies, spending more than $4.3 billion on R&D, a record-high for the 136-year-old company. In its annual summary, BI posted $23.16 billion in revenue, a 3% increase from 2019.
UPDATED: Tuesday, March 23 at 3:32 p.m.
Texas will make all adult residents eligible to receive the coronavirus vaccine, becoming the fourth state to do so, joining Alaska, Mississippi and West Virginia. The move takes effect on Monday, well ahead of President Joe Biden’s May 1 target to open vaccinations to all adults.
With Europe entering a third wave of the coronavirus, Germany has intensified a lockdown centered around Easter. Shops will be closed for five days around the holiday weekend and restrictions have been extended to April 18. The move is a U-turn from earlier this month when the country relaxed restrictions.
Regeneron and Roche posted strong results in a phase 3 trial of their COVID-19 antibody combo. The treatment, a cocktail of casirivimab and imdevimab, lowered the risk of hospitalization or death in high-risk non-hospitalized patients by 70%. It also retained its potency against five major variants and at three different doses. It gained emergency use authorization in November. The new data will aid in the treatment’s battle with Eli Lilly’s combination of bamlanivimab and etesevimab, which also has received an EUA. Story
The high-profile missteps of COVID-19 vaccine producer AstraZeneca during the pandemic continue to dominate headlines. The most recent news of the company using outdated data in reporting trial results prompted even the most measured observers to use terms such as “unprecedented” and “speechless” to describe their astonishment. Here’s a look at the AZ’s problems from a PR perspective. Story
The Leiden, Netherlands, manufacturing facility at the center of a disagreement between the European Union and the UK. is set to come online for coronavirus vaccine production and receive approval from the EU’s regulatory agency, according to Rudd Dobber, the president of AZ’s BioPharmaceuticals business. The EU threatened to block exports from the plant until AZ lived up to its supply shortfall in Europe. Story
Getting a home-delivered coronavirus test will soon be as easy as having a pizza brought to your front door. Food delivery service DoorDash will include COVID-19 test kits on its phone app. The company has partnered with Everlywell and Vault Health, two companies that have developed FDA-approved at-home test kits, which promise results in less than 48 hours. Story
UPDATED: Tuesday, March 23 at 12:02 p.m.
The European Union and the UK. are discussing a proposal to share exports of the AstraZeneca vaccine from a manufacturing facility in the Netherlands. This is an attempt to break a deadlock between the two. The EU has threatened to block exports of the vaccine until its supply obligations have been met. Both the EU and UK. believe they have legal claims and that AstraZeneca has double booked its production.
AstraZeneca may have touted outdated information in reporting results of a trial of its COVID-19 vaccine, according to the National Institute of Allergy and Infectious Diseases. The revelation touched off another controversy for the company, and AZ said it plans to submit new findings within 48 hours. Story
After the success of Pfizer and BioNTech in developing a COVID-19 vaccine, Pfizer will attempt to use mRNA technology to develop other vaccines and will do it solo, CEO Albert Bourla told the Wall Street Journal. “We are the best positioned company right now to take it to the next step because of our size and expertise,” he said.
UPDATED: Monday, March 22 at 4:23 p.m.
The push to manufacture COVID-19 vaccines is affecting supplies of some critical medicines. Pfizer for instance has notified hospitals to expect supply interruptions on four of its products—an antibiotic, a steroid and two testosterone treatments. All of them are biologic medicines that use some of the same ingredients and manufacturing capacity as the COVID vaccine.
The European Medicines Agency has advised against the use of ivermectin for prevention or treatment of coronavirus. In testing, the drug has shown ability to block replication of SARS-CoV-2, but at much higher doses than authorized. The drug is used in tablet form for treating worm infestations and as an ointment for skin conditions. It is also used for veterinary use for internal and external parasites. The EMA concluded that ivermectin use should be limited to clinical trials.
Egypt is nearing an agreement to produce the COVID-19 vaccine from Sinovac Biotech of China. Egypt hopes to become a center for manufacturing the vaccine for both local use and export to countries in Africa. Sinovac has supplied 160 million doses at home and around the world. Egypt has received less than 1 million vaccine doses, donated by China’s state-run Sinopharm.
On a Twitter post, Russia has accused the European Union of “bias” against its COVID-19 vaccine, Sputnik V. The message came after the EU’s internal market commissioner Thierry Breton said the bloc had “absolutely no need” for the vaccine. The spat comes after EU members Slovakia and Hungary issued emergency approval of Sputnik V, bypassing the EU. Tensions between Russia and the EU escalated after Europe’s jailing of Russian opposition activist Alexei Navalny last month. Russia retaliated by sending home three diplomats from EU countries.
AstraZeneca expects the European Union’s regulator to approve a factory in the Netherlands that could help ease the supply problems.
While some pharma companies were major players in the development of vaccines and treatments for COVID-19 and others weren’t, the pandemic impacted all drugmakers who had to deal with sudden changes wrought by work-at-home orders and medical office closures. Those factors plus the usual pharma concerns about pricing and regulatory issues make for a year of tumult in the industry. Story
The FDA has approved a digital armband—similar to a fitness wearable—which can screen people for COVID-19. The AI-powered device by Tiger Tech Solutions uses light sensors to detect blood flow and within three to five minutes can determine if blood is clotting more freely than usual, which is a sign of coronavirus infection. Story
UPDATED: Monday, March 22 at 10:57 a.m.
European Commission president Ursula von der Leyen said the European Union had the power to ban exports of the AstraZeneca COVID-19 vaccine if the drugmaker didn’t meet its obligations in supply-strapped Europe. While only 12% of adults in Italy, Germany and France have been vaccinated, Britain has inoculated half of its adult population, per an announcement on Saturday. Pfizer weighed in as well, warning the EU not to block vaccine exports as it has its own supply deals to meet.
Daiichi Sankyo has kicked off a phase 1/2 trial of its mRNA coronavirus vaccine candidate in Japan. Earlier this month, Daiichi began producing COVID-19 vaccines for AstraZeneca. Daiichi has agreed to fill-finish 120 million doses for distribution in Japan. Story
In a phase 3 trial conducted in the United States, Peru and Chile, the AstraZeneca COVID-19 vaccine was 79% effective preventing symptomatic coronavirus and 100% effective against severe cases, with no safety issues. The trial included 32,000 volunteers and moves the shot a step closer to approval in the United States. Story
CureVac will expand and modify its ongoing late-stage trials of its COVID-19 vaccine candidate to measure its effectiveness against emerging variants and its efficacy in the elderly. In the phase 2b/3 trial in Europe and Latin America, the rapid spread of new virus variants supports the need for further analysis to determine the efficacy of the vaccine against particular strains. For its phase 2a trial in older adults in Peru and Panama, CureVac has submitted an amendment to include a secondary objective for vaccine efficacy in 270 participants above the age of 60.
Russia continues to look to India to produce its Sputnik V coronavirus vaccine. Virchow Biotech is the latest company to agree to a supply deal, signing up to provide 200 million doses per year. The ramp up is expected to be complete by the end of the second quarter. Russia also has made similar deals with Indian manufacturers Stelis, Gland and Hetero. The four deals will provide for approximately 750 million doses this year. The vaccine has been registered in 51 countries.
UPDATED: Friday, March 19 at 2:48 p.m.
When the European Medicines Agency reiterated the safety of the AstraZeneca coronavirus vaccine on Thursday, nearly a dozen countries that had suspended use of the shot—including Germany, France and Italy—quickly resumed vaccinations. But some countries have been hesitant to follow suit and one of them, Finland, is defying the proclamation, suspending use of the AZ vaccine on Friday while it investigates two cases of recipients developing blood clots.
Meanwhile, Denmark, Sweden and Norway are in no rush to restart their AstraZeneca vaccine rollouts, saying the situation warrants more study.
On Friday, the U.S. was expected to pass the 100 million mark in coronavirus vaccine doses administered, comfortably outpacing the goal set by President Joe Biden, whose original target was to reach the benchmark by his 100th day in office. Friday is his 58th day. Biden said he would announce a new goal for the U.S. next week.
Along with partner Novartis, Incyte will give Jakafi another go as a treatment for COVID-19 patients. The drug, which is approved for use in polycythemia vera, myelofibrosis and graft-versus-host disease, failed to perform as hoped in a phase 3 trial but showed enough value in preventing death in severely ill patients in the U.S. to warrant access through a managed care program. Story
UPDATED: Friday, March 19 at 10:31 a.m.
U.S. neighbors Mexico and Canada will be the first recipients of America’s unused stock of AstraZeneca coronavirus vaccines. Mexico will get 2.5 million doses and Canada will receive 1.5 million doses. More than 30 million doses of the AZ vaccine produced domestically are in warehouses while the shot awaits authorization from the FDA.
There are four primary sources of coronavirus vaccine production. Axios tabulated how many shots China (169 million), United States (136 million), Europe (96 million) and India (68 million) have produced. While the U.S. is set to send its first shipments abroad, exports have accounted for 60% of the stock produced by China and 65% by India.
With coronavirus cases rising in Germany and the country facing a desperate need for vaccines, health minister Jens Spahn said he would support a national supply deal with Russia for its Sputnik V vaccine even though it has not been approved by the European Union. “I am actually very much in favor of us doing it nationally if the European Union does not do something,” Spahn said. German chancellor Angela Merkel will meet with state leaders on Monday to establish new shutdown rules. This month in Germany, weekly cases per 100,000 have risen from 65 to 96.
With coronavirus cases rising in France, president Emmanuel Macron has imposed a month-long lockdown in Paris and other regions. Other restrictions will have to be reestablished after Macron relaxed them in late January in an attempt to stimulate the sagging economy.
Stelis Biopharma of India will produce 200 million doses of Russia’s Sputnik V vaccine. The deal comes on top of Gland Pharma of India agreeing this week to manufacture 252 million doses of the vaccine, which has been approved for use in 50 countries. Production for both deals will commence in the third quarter of this year.
The FDA has granted its first full approval to a coronavirus diagnostic kit. BioFire got the nod for its nasal swab test. The approval will make the path easier for similar products to get full clearance. More than 340 COVID-19 diagnostic tools have received emergency use authorization. Story
A new COVID-19 test, launched by Roche, will help researchers monitor emerging variants and track mutations that make the disease more transmissible and fatal. Story
UPDATED: Thursday, March 18 at 2:45 p.m.
Amid reports of blood clots and 15 countries halting its use, the European Medicines Agency has declared the AstraZeneca COVID-19 vaccine “safe and effective.” The EMA said it couldn’t “definitively” rule out a link between the shot and rare blood clots, so it’s moving raise awareness of possible risks. Leaders in France and Italy said earlier this week that they would reinstate use of the vaccine if it was endorsed by the EMA. Story
The U.S. has halted distribution of Eli Lilly’s COVID-19 antibody treatment bamlanivimab in Californa, Arizona and Nevada because of concerns over the spread of a variant. The policy extends only to sales of bamlanivimab alone. Lilly’s combination of bamlanivimab and etesivimab remains available in all states. The news comes after the FDA ordered Lilly and Regeneron to monitor their antibody treatments’ effectiveness against variants. Story
The pharma industry has traditionally scored poorly in public opinion polls, but that’s changing thanks to its rapid response to the coronavirus pandemic. As a result, many pharma and biotech companies are looking for ways to optimize their corporate images, according to an expert in the field. Story
UPDATED: Thursday, March 18 at 10:45 a.m.
A Sanofi exec said he hopes collaboration among major drugmakers will cast a better light on the drug industry, which is often criticized for its high prices. “I think it’s showing to the world that sometimes this industry that can be, sometimes, a little bit differently perceived in the media … what we have at the heart of this industry,” EVP and vaccines chief Thomas Triomphe told Yahoo France. After its first COVID-19 vaccine candidate stalled in development, Sanofi signed up to fill-finish shots made by other companies. A Sanofi site in Germany services the Pfizer–BioNTech coronavirus vaccine, while a plant in France does the same for the Johnson & Johnson vaccine.
A supply shortfall is threatening to push back the UK.’s plan for COVID-19 vaccinations. The National Health Service warned local health organizations of reduced supplies in April. A shipment from the Serum Institute of India has been delayed for four weeks. Another batch of 1.7 million doses from Serum needs to be retested for stability. The plan to offer vaccines to people over age 50 on April 15 and to all adults by the end of July remains intact.
Merck KGaA plans to amp up production of single-use materials used in manufacturing COVID-19 vaccines. The German drugmaker will add a single-use assembly unit at its manufacturing site in Molsheim, France. The new capacity will come online in the fourth quarter of this year and will become the company’s first facility in Europe to turn out the materials. The $30 million investment will include 350 new employees. Merck KGaA facilities in Danvers, Massachusetts, and Wuxi, China, are already manufacturing the materials.
Gland Pharma of India has agreed to supply 252 million doses of Russia’s Sputnik V COVID-19 vaccine. Production is expected to begin the third quarter of this year. The vaccine has been approved in 22 countries. Another Indian firm, Hetero, will produce 100 million doses of the Sputnik shot.
An Oxford study shows that existing vaccines may protect against the Brazilian variant of the coronavirus more effectively than first believed. The study measured the level of antibodies that can neutralize variants and examined the performance of natural antibodies of those who had been infected with COVID-19 vs. vaccine-induced antibodies.
A former Pfizer executive co-authored a petition to the European Medicines Agency last fall demanding that COVID-19 vaccines be halted because they could cause infertility in women. Michael Yeadon, 60, a former Pfizer researcher and VP who co-founded a biotech later purchased by Novartis, was a driving force behind the movement. The petition, which cited no evidence and appeared Dec. 1 on a German website, failed to sway regulators who approved of the Pfizer–BioNTech vaccine weeks later, according to a Reuters special report.
Sudden onset hearing loss has occurred in some recipients of COVID-19 vaccines. The condition, which strikes 11 to 77 per 100,000 people yearly in the U.S., has been registered 14 times among the 31,000 entries in the new Vaccine Adverse Event Reporting System. Many of the cases have come within the first two weeks of inoculation and the effects have been temporary. It’s too soon for experts to establish a link.
UPDATED: Wednesday, March 17 at 4:12 p.m.
The World Health Organization reiterated its support for the AstraZeneca COVID-19 vaccine on Thursday, saying that its benefits outweigh risks. The WHO’s Global Advisory Committee on Vaccine Safety will continue to assess data.
Clofazimine, which was approved by the FDA in 1986 for the treatment of leprosy, significantly reduced viral load and shedding in hamsters, indicating it might be effective fighting COVID-19. The University of Hong Kong has launched a phase 2 study testing a combination of clofazimine and interferon beta on hospitalized patients. Story
Governments are intent on building up their vaccine and biologics infrastructure to insulate themselves from the kind of supply disruptions witnessed during the COVID-19 pandemic, according to Stefan Oschmann, the CEO of Merck KGaA. Story
UPDATED: Wednesday, March 17 at 9:45 a.m.
A double dose of AstraZeneca‘s vaccine was just 10.4% effective against mild-to-moderate infections with the B1351 variant identified in South Africa, a phase 1b-2 study published in the New England Journal of Medicine found. Out of 750 people who received the vaccine, 19, or 2.5%, developed mild-to-moderate disease more than 14 days after the second dose, versus 23 infections among the 717-subject placebo arm. Of the 42 COVID-19 cases reported, 39, or nearly 93%, were caused by B1351.
Once COVID-19 moves “from a pandemic situation to an endemic situation,” Pfizer sees “significant opportunity” for its vaccine “from a pricing perspective,” Frank D’Amelio, CFO & executive VP of global supply, said at a Barclays virtual healthcare conference last week. Once the pandemic phase subsides, normal market conditions will start to kick in, and D’Amelio predicts Comirnaty’s strong clinical profile will put it in high demand. Story
Catalent will expand its production capacity in Europe to manufacture the Johnson & Johnson COVID-19 vaccine. A plant in Anagni, Italy, will bring on a second production line in the fourth quarter of this year. Story
States are hustling to expand vaccine access after President Joe Biden last week said he would order them to make all adults eligible for the shot by May 1. Maine, Virginia and Wisconsin, as well as Washington D.C., have pledged to meet that deadline, while Colorado, Connecticut, Ohio, Michigan, Montana and Utah aim to expand access before then. Since December, the U.S. has delivered some 143 million vaccine doses to states and territories, the CDC says. It’s now averaging about 2.4 million shots a day, more than double its distribution output in January.
President Biden said he is in talks with several countries about distributing surplus COVID-19 vaccines. He previously said he intends to ensure all Americans have access to vaccinations before shipping available stock overseas. Mexico has requested America’s unused AstraZeneca shots; the shot isn’t approved in the U.S. but is in use in Mexico.
Ships will duke it out with planes to deliver COVID-19 vaccines this year as air freight capacity is exhausted and shots make their way to Africa, Asia and South America, the head of pharmaceuticals at the container group Maersk told the Financial Times. By the middle of the year, Maersk’s Hristo Petkov predicts half of all vaccine distribution will occur locally via trucks and short-haul flights, with ships and planes battling over the remaining half. Land and air have prevailed in the distribution push so far because the factories making those vaccines are mainly based in Europe, India and the U.S.—close to early recipients.
French President Emmanuel Macron and Italian prime minister Mario Draghi said they will restart the use of the AstraZeneca COVID-19 vaccine if it is cleared by the European Medicines Agency. The countries are among 15 in Europe that have stopped administering the shot based on reports of blood clots.
Meanwhile, the EMA is expected to grant AstraZeneca‘s vaccine safety clearance Thursday. The investigation is still ongoing, but the agency remains “firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19 … outweigh the risks of these side effects,” said Emer Cooke, executive director of the EMA.
Plus, France faces “a kind of third wave” of COVID-19 infections, Prime Minister Jean Castex said Tuesday, linking the surge to emerging virus variants. The country is grappling with widely reported mutants from the UK., South Africa and Brazil, and also has concerns about a new variant in Brittany, which it classifies as a “variant under investigation.” The variant doesn’t seem to increase transmissibility or disease severity, according to a first analysis.
UPDATED: Tuesday, March 16 at 3:03 p.m.
The FDA has altered its emergency use authorizations for Eli Lilly and Regeneron’s COVID-19 antibody drugs and is now requiring the companies to monitor emerging coronavirus variants and to potentially test their drugs against them. The guidance applies to Regeneron’s combination of casirivimab and imdevimab and to Lilly’s bamlanivimab and its combo treatment of bamlanivimab and etesevimab. All of the drugs are for patients with mild to moderate cases of COVID-19. Coronavirus variants, especially the South African strain, have shown increased resistance to antibody treatments. Story
Maryland-based Emergent BioSolutions will receive aid from the Canadian government as it expands its plant in Winnipeg. The factory already has the capability of manufacturing vaccines, including COVID-19 shots. The deal could provide Canada with its first domestic plant manufacturing COVID-19 vaccines. Story
AstraZeneca’s COVID-19 vaccine is under relentless fire, but analysts from Jefferies believe the company is positioned well because of its pipeline of promising drugs and the strength of its oncology offerings. Story
UPDATED: Tuesday, March 16 at 11:03 a.m.
Pfizer–BioNTech’s total supply of COVID-19 vaccine doses to Europe will reach 200 million by the end of the second quarter, according to European Commission president Ursula Von der Leyen. Reuters confirmed the figure with Pfizer. The shipments include 10 million doses, previously earmarked for later delivery, that will be expedited. Also in the second quarter, the EU expects to receive 55 million doses of the single-shot Johnson & Johnson vaccine and 35 million doses of the Moderna shot. Europe hopes to have 70% of its population vaccinated by the end of the summer.
AstraZeneca has modified an agreement with the United States to supply up to 500,000 additional doses of AZD7442, an experimental, long-acting antibody combination for the prevention and treatment of COVID-19. This deal builds on an October contract to support late-stage development of the drug and an initial supply of 100,000 doses. AZ already had a pact with the DoD to supply 100,000 doses of the drug.
Moderna has dosed the first children in a phase 2/3 study of its mRNA vaccine. The study, conducted along with the NIH, includes kids between the ages of 6 months and 11 years in the United States and Canada. It will include approximately 6,750 participants.
The FDA has launched a website to track side effects from COVID-19 treatments that have received emergency use authorization. The FDA Adverse Event Reporting System is a public dashboard that will be updated weekly. In its debut week, the dashboard registered 8,627 reports with 5,000 determined to be serious and an additional 1,404 reporting a death. Story
Maryland-based Emergent BioSolutions will receive aid from Canada as it expands its plant in Winnipeg. The factory can already manufacture vaccines, including COVID-19 shots.
Sweden and Latvia joined a growing list of European countries that have suspended use of the AstraZeneca COVID-19 vaccine. Sweden’s move is pending a report from the European Medicines Agency, expected later this week. The European Union’s three largest countries—Germany, Italy and France—discontinued use of the shot on Monday. Meanwhile, Venezuela said it would not authorize use of the AZ vaccine.
The World Health Organization’s committee on vaccine safety will meet on Tuesday to discuss the AstraZeneca COVID-19 shot and reports of it causing blood clots. Meanwhile, WHO’s chief scientist Soumya Swaminathan urged people not to panic, saying that the incidence of blood clots to AZ vaccine recipients has been “less than what you would expect in the general population.”
AstraZeneca chief Pascal Soriot is on the “hot seat” over delivery delays of its COVID-19 vaccine, according to France’s industry minister Agnes Pannier-Runacher. The company originally agreed to provide 90 million doses to the European Union by the end of March but revised that number to 30 million last week.
UPDATED: Monday, March 15 at 3:10 p.m. PM
Problems continue to mount for AstraZeneca’s COVID-19 vaccine. On Monday, Germany became the largest country to join the growing list of those suspending use of the shot. The company has been beset with supply problems, especially in Europe. And confidence in the vaccine is declining with reports of it causing blood clots. Over the weekend, the company issued a statement defending the jab’s safety. Story
In another bit of negative news regarding AstraZeneca’s COVID-19 vaccine supply shortfall in Europe, the company’s revised goal of providing 30 million doses of the shot, which is 60 million fewer than originally promised, is not even assured. The new target hinges on the European Union’s regulator approving supplies from a factory in the Netherlands, according to an internal document.
Moderna was quick to develop a COVID-19 vaccine. Now it has started phase 1 testing of its next-gen mRNA COVID-19 vaccine, which would be refrigerator stable and easier to distribute and administer than its current shot.
Early commercial batches of the Pfizer–BioNTech COVID-19 vaccine had lower levels of mRNA than clinical batches, which prompted major concerns for regulators from the European Medicines Agency before the shot was approved. The information came by way of an EMA cyberattack which was leaked to journalists. While the production issue has been resolved, the incident demonstrates the complexities of quality assurance for mRNA vaccines. Story
After one failed attempt to develop a COVID-19 drug, Molecular Partners and Novartis have partnered again for another try. On Monday, they announced that ensovibep will be included in an NIH global phase 3 clinical trial, ACTIV-3, which evaluates therapies for the treatment of adults hospitalized with COVID-19. Story
Customers visiting Black-owned barbershops in New York, Chicago and the Raleigh-Durham area will get more than a haircut. They’ll also get facemasks, hand sanitizer and information on how to join a treatment trial if they become infected with COVID-19. The marketing effort is by ACTIV, a public/private initiative created by the NIH to help overcome the community’s distrust of the medical field, especially in regard to trials and experiments. Story
UPDATED: Monday, March 15 at 10:57 p.m. ET
The European Union will begin depending more on Pfizer and BioNTech for its COVID-19 vaccine supply, according to EU industry commissioner Thierry Breton. The news came shortly after AstraZeneca warned the EU of a supply shortfall. The company had originally pledged to deliver 90 million vaccine doses by the end of the first quarter but told the EU on Friday to expect only 30 million doses to arrive by the end of March.
With some countries refusing to administer the AstraZeneca COVID-19 vaccine, the company issued a strong written response defending its safety. Data from more than 17 million vaccine doses showed “no evidence of increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” according to the release. The number of reported cases of DVT (15) and pulmonary embolism (22) is “much lower than would be expected to occur naturally in a general population of this size,” added the release. Story
Three people in Norway have been hospitalized with blood clots after receiving the AstraZeneca COVID-19 vaccine. The country was among seven in Europe which last week shut down vaccines with all or part of their available AZ stock. The European Medicines Agency will investigate.
Add Ireland and the Netherlands to the growing list of countries that have suspended use of the AstraZeneca COVID-19 vaccine. Both countries took the action after reports of three vaccine recipients in Norway being hospitalized with blood clots. On Friday, Thailand became the first country outside of Europe to halt vaccinations. Ireland’s chief medical officer Ronan Glynn said: “We may be overreacting. … Hopefully we will have data to reassure us in a few short days and we will be back up and running with this.”
The U.S. will continue to sit on its stockpile of the AstraZeneca COVID-19 vaccine amid pressure to send the supply overseas. The AZ shot has yet to be approved in the U.S. “We have a small inventory of AZ so that, if approved, we can get the inventory out to the American people as quickly as possible,” said COVID-19 response coordinator Jeff Zients, in a press briefing. “We’re rightly focused on getting Americans vaccinated as soon as possible.”
Takeda announced a mutual agreement with IDT Biologika and Johnson & Johnson for the Germany-based CDMO to manufacture the J&J COVID-19 vaccine. Takeda had originally reserved IDT to produce its dengue fever vaccine, which is subject to regulatory approvals. The agreement with J&J extends over the next three months.
Novo Nordisk is in preliminary talks with the Danish government to establish local vaccine production. The news comes after prime minister Mette Frederiksen expressed concern over delays in the European Union in supplying COVID-19 vaccines. Novo Nordisk has production facilities in eight countries.
Molecular Partners AG and Novartis announced that its COVID-19 drug ensovibep will be included in an NIH global phase 3 clinical trial. ACTIV-3 evaluates various therapies for the treatment of adults hospitalized with COVID-19. Ensovibep binds the receptor-binding domain of the SARS-CoV2 spike protein to prevent entry into cells and may provide added protection against variant strains.
Facebook has launched a global campaign to help people get vaccinated. The Covid Information Center will appear in users’ news feeds with a link to schedule an appointment. Facebook also will bring the information center to Instagram and is urging governments to expand their WhatsApp chatbots to help people register.
UPDATED: Friday, March 12 at 3:59 p.m. ET
AstraZeneca has revised its estimate for delivery of its COVID-19 vaccine to Europe in the first quarter and the news isn’t good. After originally agreeing to supply 90 million vaccine doses in the first quarter, the company on Friday said only 30 million will be possible. Story
In a related report, the European Union has been told not to expect supplies of the vaccine anytime soon from AZ’s manufacturing facilities in the United States.
Also with regard to the AZ vaccine, Germany and a few other large European countries are expressing disappointment in countries that have suspended use of all or some of their vaccine supplies from the company.
Piloting Pfizer through its rapid and successful response to the COVID-19 pandemic has paid off for Albert Bourla. The Pfizer CEO collected more than $21 million last year, according to a proxy filing submitted Friday. The company is eyeing $15 billion in COVID-19 vaccine sales this year. Story
Also on Bourla, the Pfizer chief said it was a “question of weeks” until kids ages 12-16 could start receiving the COVID-19 vaccine, pending approval from the FDA. Pfizer recently enrolled more than 2,000 children ages 12-15 in clinical trials. Further, praising the efforts of Israeli prime minister Benjamin Netanyahu to secure Pfizer vaccines, Bourla said the prime minister “called me 30 times.”
Analysts from Jefferies took a detailed look at how pharma companies have fared during the coronavirus pandemic and assessed their fitness to deal with another crisis. Some products, such as GlaxoSmithKline’s Shingrix, suffered because older adults were hesitant to visit clinics. Others, like Sanofi’s flu shots, thrived. Overall, companies best suited to a crisis are ones with a diversified portfolio of drugs. Story
Jefferies further lays out a case that companies could benefit from products that combat “long COVID” problems, including mental health, lung scarring, kidney disease and heart failure.
In phase 2 and 3 testing, Novavax’s COVID-19 vaccine showed vastly different efficacy protection rates against the British (86%) and South African (49%) variants. But regardless of the strain, the vaccine was 100% effective in preventing severe forms of the disease. Of 10 people who developed severe COVID-19 cases, all were placebo recipients. Story
Altimmune has expanded its manufacturing agreement with Lonza to produce its AdCOVID intranasal vaccine candidate. Lonza’s facility in Houston, Texas, will handle clinical and commercial production. The vaccine has been shown in early studies to activate mucosal immunity which could prevent infection and transmission of the disease.
UPDATED: Friday, March 12 at 11:18 a.m. ET
Thirty million doses of the AstraZeneca COVID-19 vaccine are sitting in a facility in Ohio while other countries are asking to use them, The New York Times reports. The AZ shot has yet to be approved in the U.S. There are discussions within the government about the risk of expiration as the shelf life of the AZ jab is six months. Possible solutions are to ship them to Europe or COVID-ravaged Brazil.
Pfizer and Moderna are scheduled to have delivered 100 million COVID-19 vaccine doses to the U.S. each by the end of March. So how are they doing? As of Wednesday afternoon, Moderna had supplied 64 million doses while Pfizer had supplied 61 million. While deliveries lagged early in the year, they’ve stepped up dramatically. Over the last two weeks, both companies have provided 20 million weekly doses each. Continuing that trend would allow both to meet the goal.
Pfizer–BioNTech announced that real-world data from Israel shows that their COVID-19 vaccine is 94% effective in preventing asymptomatic infections, meaning it could significantly reduce transmission. The vaccine also was 97% effective in preventing severe disease and death. In addition, data shows better than 80% efficacy against the British variant of the coronavirus.
Sanofi and Translate Bio announced a phase 1/2 trial for their mRNA COVID-19 vaccine candidate. The companies expect results in the third quarter of this year. Story
Pfizer–BioNTech will supply Japan with 100 million doses of its COVID-19 vaccine by June, a month before the Olympic Games are scheduled to begin in Tokyo. In May, Japan expects to receive 10 million doses per week from Pfizer, followed by increased amounts in June. This order will allow Japan to inoculate 50 million people, half the country’s population. The International Olympic Committee has said it will not jump the line to vaccinate athletes.
Daiichi Sankyo has begun manufacturing the AstraZeneca COVID-19 vaccine in Japan, filling vials and packaging them for shipment. AZ has agreed to supply Japan with 120 million vaccine doses, 30 of which will be provided through Daiichi Sankyo and KM Biologics. Production of the other 90 million doses will be handled by JCR Pharmaceuticals.
ApiJect Systems announced that Raymond J. Guidotti is its new Chief Operating Officer. He brings 30 years of pharma experience, most recently at Thermo Fisher, to the company that specializes in vaccine production.
UPDATED: Thursday, March 11 at 4:24 p.m. ET
Europe has approved the Johnson & Johnson single-shot COVID-19 vaccine, accepting the recommendation of the European Medicines Agency from earlier in the day. It is the fourth coronavirus vaccine endorsed by the EU, joining the two-shot vaccines from Moderna, Pfizer–BioNTech and AstraZeneca.
Vir Biotechnology and GlaxoSmithKline announced that a trial evaluating VIR-7831 as a therapy for early treatment of high-risk COVID-19 patients has been stopped due to profound efficacy. Based on 85% success, the companies will apply for emergency use authorization from the FDA. Story
A Merck facility in Durham, N.C. will produce bulk substance for manufacture of the Johnson & Johnson COVID-19 vaccine and will receive $105.4 million from the U.S. government for upgrades. The two pharma giants entered into a “wartime” agreement last week allowing J&J to increase vaccine production. Story
Seven countries in Europe have halted distribution of some or all of their AstraZeneca COVID-19 vaccine supplies. Austria started the wave after a clotting issue turned up in one recipient. Then Estonia, Latvia, Lithuania and Luxembourg stopped using vaccines from the same batch. Denmark and Norway followed suit, halting all AZ vaccinations. This is the latest in a series of negative reports about the vaccine which has been plagued by supply shortfalls in Europe and questions about its safety and effectiveness, which have led to unused stock in some countries. Story
In a related story, the European Medicines Agency found no linkage between two people in Austria who became ill after receiving the AstraZeneca COVID-19 vaccine. One of the people, 49, died 10 days after receiving the shot.
There are differing public perceptions about the AstraZeneca COVID-19 vaccine: one in the UK. and another in the rest of Europe. A poll by YouGov found that 81% of Brits believe the AZ vaccine is safe, even more so than the Pfizer shot (79%). In Germany (43%) and France (33%) however, faith in the AZ jab is much lower. Developed at Oxford, the AZ shot was rolled out in England as a source of public pride. But supply issues, reports of side effects and doubts about the vaccine’s effectiveness among the elderly and safety have chipped away at its reputation in some areas of Europe. Story
Researchers in the UK. have identified a key inflammatory protein which could be linked to severe COVID-19. In an analysis of more than 500 COVID-19 patients, researchers identified a cytokine (GM-CSF) which was present at higher levels in those who progressed to critical conditions. The protein also was found to be nearly 10 times higher in those who died. Researchers believe this discovery could help detect those most at risk and provide a target for new treatments.
Pfizer will wait until the “pandemic supply phase” is over before considering production of its COVID-19 vaccine outside of Europe and the United States. The statement from the company came after a Reuters report that Pfizer told India that it would produce its shot there if assured of regulatory clearance and freedom on pricing and exports.
We’ve yet to emerge from the coronavirus pandemic, but Abbott is planning for the next one. The company is launching a Pandemic Defense Coalition to detect and track emerging viruses and dangerous mutations. The network will include centers with expertise in lab testing, genetic sequencing and public health. Since the team plans to publish their findings, other scientists will be able to determine if new viruses pose threats.
Jubilant has agreed to terms with Eli Lilly to produce bamlanivimab, a treatment for COVID-19 which recently was granted emergency use approval from the FDA. The drug will be manufactured in Seattle by Jubilant’s subsidiary, Jubilant HollisterStier.
The governors of Colorado and Oregon have asked the FDA to allow COVID-19 vaccine pooling. The strategy combines leftovers from different vials of the same type of vaccine, stretching the supply. The FDA advises against the practice, citing contamination and infection risks. The governors argue the benefits outweigh the risks.
Novartis has invested $23.8 million in its manufacturing site in Kundl, Austria, which will produce COVID-19 vaccines for CureVac. The facility will pump out 50 million doses by the end of this year and up to 200 million in 2022. It also will add up to 100 employees as part of the ramp up.
On the anniversary of the World Health Organization declaring the coronavirus pandemic, Pfizer CEO Albert Bourla wrote in an open letter posted on the company’s website. Bourla recognized the surge of optimism that has accompanied vaccine rollouts but also stressed the importance of maintaining social distance and wearing masks until herd immunity is achieved.
UPDATED: Thursday, March 11 at 11:21 a.m. ET
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, recommending that the Johnson & Johnson COVID-19 vaccine be approved. Data from the Ensemble study showed the single-shot vaccine was 85% effective in preventing severe disease. The vaccine was authorized by the FDA for use in the United States on Feb. 27. Europe has approved vaccines from Pfizer–BioNTech, Moderna and AstraZeneca.
Phase 3 testing of Roche’s Actemra (tocilizumab) as an add-on to Gilead Sciences’ remdesivir—now sold as Veklury in the U.S.—failed to top Veklury alone in patients with severe COVID-19 pneumonia. Roche’s Genentech unit will continue to evaluate data from this study and others using Actemra on coronavirus patients with pneumonia. Story
Denmark has suspended use of the AstraZeneca COVID-19 vaccine for 14 days after reports of blood clots and one death. The precautionary measure will give experts time to determine whether the incidents are linked to the vaccine. Shots from the same batch were suspended last week in Austria after the death of one woman. But the European Medicines Agency ruled out the vaccine as a cause. Estonia, Latvia, Lithuania and Luxembourg also have stopped using the batch.
Los Angeles informed residents of a slowdown in the administration of COVID-19 vaccines, blaming a shortage of shots from Johnson & Johnson. The warning comes as people with underlying health conditions become eligible on Monday. The scarcity is a statewide problem, said Gov. Gavin Newsom, who added that he expects a steadier and stronger stream of deliveries by “next month.”
Cancer patients who receive one Pfizer COVID-19 vaccine have little protection against the disease, according to a study in the UK. After a second shot, however, the patients had the same level of protection as those who are cancer-free. Among 151 people with solid cancers (lung, breast, bowel), 39% were protected three weeks after receiving one Pfizer shot. Among 54 people with blood cancers, just 13% were protected. This compares to a 97% protection rate for those without cancer.
UPDATED: Wednesday, March 10 at 3:14 p.m. ET
Thermo Fisher will pour more than $600 million into capital investment which will help the CDMO meet COVID-19 demand in the short term and more than double production capacity in the long term. Thermo Fisher will add at least 1,500 new employees as part of the expansion. The upgrades, at 11 Thermo Fisher facilities in the Americas, Europe and Asia, will be complete by the end of 2022. Story
The British variant of COVID-19 has been detected in 31 of 39 wastewater treatment plants in Houston, suggesting the more transmissible variant is spreading quickly. The samples are from Feb. 22. When the same tests were done on Feb. 8, the UK. variant was detected at just 21 of the plants. “It’s actively spreading in our city,” said Houston’s chief medical officer David Persee. The news comes amid Texas relaxing coronavirus safety measures.
UPDATED: Wednesday, March 10 at 10:55 p.m. ET
The United States has agreed to purchase 100 million additional COVID-19 vaccines from Johnson & Johnson. President Joe Biden will announce the deal on Wednesday afternoon, according to media reports, which brings U.S. supply to 800 million doses, more than enough for the U.S. to vaccinate its entire adult population. The U.S. had already locked down enough to do so with last month’s deals for 200 million doses from Moderna and Pfizer. Story
Eli Lilly’s antibody combination of bamlanivimab and etesevimab reduced hospitalizations and death by 87% in high-risk patients recently diagnosed with COVID-19. The results, from a phase 3 study in 769 patients, showed an improvement on the 70% figure in a previous test of a 2800 mg/2800 mg mixture. The most recent study used a 700 mg bamlanivimab/1400 mg etesevimab blend. Combining both studies, there were 13 COVID-19 related deaths in patients receiving placebo and none in patients who received either antibody concoction. Story
Canadian prime minister Justin Trudeau said Johnson & Johnson has warned of manufacturing problems with the company’s COVID-19 vaccine, which was endorsed for use in the country last week. Canada has ordered 10 million doses of J&J’s single-shot vaccine. More than 5% of the country’s 38 million people have been vaccinated so far. Earlier this week, the European Union got the same warning from J&J.
Pfizer–BioNTech could have the capacity to make 3 billion doses of its two-shot COVID-19 vaccine by next year, according to BioNTech CEO Ugur Sahin. The two companies are scheduled to produce 2 billion doses this year, which includes a contract to provide 500 million doses to the European Union.
VBI Vaccines is launching a phase 1/2 study in Canada of its COVID-19 vaccine, VB-2902. The company also announced a partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop vaccine candidates to combat SARS-CoV-2 variants. CEPI will provide $33 million to advance VBI-2905 specifically against the South African strain. VBI develops enveloped virus-like particle (eVLP) vaccines. The company is based in Massachusetts, with research operations in Canada and a manufacturing site in Israel.
The British variant of COVID-19 is between 30% to 100% more lethal than previous strains, according to researchers. The study compared death rates among those in Britain infected with the variant, known as B.1.1.7, against those infected with other strains. In a group of 54,906 COVID-19 patients, there were 227 deaths among those infected with the variant as opposed to 141 deaths among the same number of patients with other strains. Researchers also discovered that the variant is 40% to 70% more transmissible.
World Trade Organization members opened talks on Wednesday on a joint proposal by South Africa and India to waive intellectual property rights on certain COVID-19 technologies. The International Federation of Pharmaceutical Manufacturers Associations opposes the proposal, contending that supply bottlenecks and the scarcity of raw materials are preventing pharma companies from increasing capacity. In a letter to President Joe Biden, members of PhRMA also urged him to oppose the push.
UPDATED: Tuesday, March 9 at 3:47 p.m. ET
In a letter to President Joe Biden, the Pharmaceutical Research and Manufacturers of America has requested that he oppose a push to suspend critical provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. In October, India and South Africa requested the World Health Organization to suspend TRIPS during the coronavirus pandemic. PhRMA contends that there is no evidence that intellectual property protections are hindering the global response to the pandemic.
The FDA has approved Cue Health’s cartridge-based nasal swab test that can be done completely at home without a prescription. The kit includes a battery-powered cartridge reader that connects to a smartphone app. Results are available in 20 minutes. The company said it expects to be able to produce 100,000 tests per day by the summer. Story
Johnson & Johnson revealed that trials for its COVID-19 vaccine, which was recently approved for use in the United States, had largely been done virtually through IQVIA. The virtual tests began in September. Contract research organizations have been offering siteless trials since the first wave of the pandemic last year. Story
UPDATED: Tuesday, March 9 at 10:14 a.m. ET
How much money will the makers of the three COVID-19 vaccines approved for use in the U.S. make from their shots? Fox Business breaks it down. Pfizer and BioNTech will generate $15 billion in revenues this year from sales of 1.3 billion doses. Moderna expects to supply 1 billion doses in 2021 and 1.4 billion in 2022 for a total haul of $18.4 billion. Johnson & Johnson is on track to supply 1 billion doses of its single-shot vaccine in 2021 for $10 billion in revenue.
The COVID-19 vaccine by AstraZeneca will soon be under review by the FDA. But approval could be complicated by testing data that’s inconclusive. An ongoing phase 3 study in the U.S. and South America could answer many of the questions about the vaccine’s effectiveness in the elderly, which dosing regimen works best and how the shot performs against variants. On Friday, AZ executive Ruud Dobber told CBS News that the company will seek emergency use authorization in the U.S. in “the next few weeks.”
Europe has been beset by supply problems for coronavirus vaccines. Now comes word that the European Union may be facing similar issues from Johnson & Johnson, which has warned the bloc of problems that may impact supply in the second quarter, an EU official told Reuters. The J&J vaccine is expected to be endorsed for use in Europe later this week. The company has agreed to supply the EU with 200 million doses this year. Story
The COVID-19 vaccine from Pfizer–BioNTech is effective against the more infectious Brazilian strain of the virus, according to a lab study. The pharmaceutical companies and the University of Texas took blood samples from people who had received the Pfizer vaccine and put them in contact with an artificially created P1 Brazilian virus. The samples from vaccinated people negated the virus. The variant has surged through Brazil, reinfecting people who previously had the virus. The Pfizer vaccine has also performed well in tests vs. the variants from Great Britain and South Africa. Story
As it deals with a brutal second wave of coronavirus deaths, Brazil is seeking to buy AstraZeneca vaccines from other countries and is pressing Pfizer for early delivery of its vaccine. Studies have shown both vaccines are effective against Brazil’s more infectious P1 strain of the virus. Less than 4% of the country has been inoculated.
Greece and Norway joined a growing list of European countries offering the AstraZeneca COVID-19 vaccine to the elderly. In light of recent studies, Greece reversed a previous ruling restricting use of the AZ shot for those age 65 and older. Norway did the same on Tuesday. Last week, France, Germany, Sweden and Hungary endorsed the AZ shot for the elderly.
UPDATED: Monday, March 8 at 4:04 p.m. ET
While promoting its coronavirus vaccine, Sputnik V, through social media, Russia also has mounted a campaign to undermine confidence in Western COVID-19 vaccines, according to the State Department. Meanwhile, the Sputnik V Twitter account, which reaches the world with cheeky commentary, notched verified status last week. Story
After several missteps in its COVID-19 research efforts, Merck got some positive news in a trial of molnupiravir. The antiviral drug, developed along with Ridgeback, has hit secondary objectives in a new trial, showing a reduction in positive viral culture. Story
CytoDyn’s leronlimab has missed all primary and secondary endpoints in a phase 3 trial of its COVID-19 drug. But by focusing on a subset of severely ill patients on ventilators, CytoDyn found an improved chance of survival and a reduction in the length of hospital stays. Story
UPDATED: Monday, March 8 at 11:04 a.m. ET
Baxter BioPharma Solutions will help manufacture and supply 60 million to 90 million doses of the Moderna COVID-19 vaccine this year from its plant in Bloomington, Ind. The companies announced the agreement on Monday. Baxter will help with the fill-and-finish portion of the manufacturing process.
At least one in five Europeans would refuse the AstraZeneca COVID-19 vaccine, according to an opinion poll by YouGov. Trust in the two other vaccines, from Pfizer and Moderna, is much higher, according to the poll. In Germany, for example, 27% of people said they would turn down the AZ vaccine and wait for another, compared to a 12% refusal rate for the Moderna vaccine and 6% for the Pfizer–BioNTech shot. Last week, several European countries, including France, Hungary and Germany, allowed the elderly to receive the AZ vaccine after initially limiting its use.
Austria has suspended the use of a batch of AstraZeneca COVID-19 vaccine as it investigates the death of one woman and the illness of another. Both were nurses working in a clinic in Zwettl. A 49-year-old nurse died from coagulation disorders. The other, 35, suffered a pulmonary embolism. The vaccine was deemed safe in clinical trials.
Ivermectin, a drug to combat parasitic worms and head lice, should not be used to prevent or treat COVID-19, according to the FDA. Some people have experimented with another form of the drug, commonly given to horses, and have been hospitalized. Misinformation has allowed some unproven COVID-19 treatments to gain traction, including hydroxychloroquine, a malaria drug touted by former President Donald Trump.
Bharat Biotech has begun phase 1 testing of its second COVID-19 vaccine, a single-dose nasal spray. Bharat has already developed Covaxin, a two-shot vaccine that has posted 82% efficacy in a phase 3 trial. Intranasal vaccines have attracted attention because they are easily administered and can be used quickly to cover a large population.
Antibody-drug developer Prestige BioLogics will build a vaccine production center for COVID-19 and other infectious diseases. The construction will begin this month and be complete by the end of the year. “The pandemic is increasing concerns about virus infections in the future while raising expectations about related vaccines,” Prestige CEO Park So-yeon told Korea Biomedical Review.
UPDATED: Friday, March 5 at 3:52 p.m. ET
There’s a debate within the Catholic Church over the morality of taking the Johnson & Johnson COVID-19 vaccine. This week, the U.S. Conference of Catholic Bishops said it’s “acceptable to receive Covid-19 vaccines that have used cell lines from aborted fetuses” when others aren’t available. The USCCB favors the Pfizer and Moderna vaccines, but said that considering the global pain caused by COVID-19, “being vaccinated can be an act of charity that serves the common good.” However, one bishop, David Kagan of North Dakota, has prohibited those in his diocese from taking the J&J shot.
Manufacturers of COVID-19 vaccines around the world could soon be feeling the pinch of the United States’ move to lock up raw materials and supplies for Pfizer. The Serum Institute of India, the world’s largest producer of vaccines, and the World Health Organization are warning of supply bottlenecks that could slow production. Story
A Pfizer plant in Kansas has a long history of quality and sanitary issues, but is lined up to manufacture COVID-19 vaccines for the company. The FDA has repeatedly flagged the factory for violations, most recently in January of 2020 when mold and bacteria were discovered in areas that were supposed to be sterile. Pfizer maintains that the problems have been remedied. Story
Wells Fargo will give employees up to eight hours of paid time off to take care of COVID-19 vaccine appointments, the company announced. The bank also will provide free coronavirus testing at its 25 largest hubs, while other employees required to report to the office can request free at home-testing kits.
UPDATED: Friday, March 5 at 11:15 a.m. ET
Pfizer CEO Albert Bourla has postponed a visit to Israel because he and his delegation are not fully immunized against the coronavirus, according to an Israeli TV report. Bourla, 59, has said he would not cut the line for a vaccine. Last week, Israeli prime minister Benjamin Netanyahu announced the Pfizer visit and suggested the possibility of Pfizer building a plant in the country. With elections upcoming, Netanyahu had touted his relationship with the company as key to Israel’s successful vaccination push.
Australia has asked the European Commission to review Italy’s decision to block the export of the AstraZeneca COVID-19 vaccine to its country, a move that was signed off on by the EU because of AZ’s failure to meet contracted supplies. While Australian prime minister Scott Morrison requested the review, he also said he could appreciate the decision by Italy where “people are dying at the rate of 300 a day.” Italy has had 99,000 COVID-19 deaths compared to 900 for Australia. Meanwhile other European countries are offering various levels of support for Italy’s move.
Pakistan will rely solely on free COVID-19 vaccines donated by friendly countries. World relief effort COVAX will deliver 16 million doses of the AstraZeneca vaccine to Pakistan by the end of June. China has already supplied half of a 1 million dose commitment of Sinophram vaccines. Pakistan has administered 275,000 of those doses to health professionals.
Hungary joined the growing list of European countries allowing the elderly to take the AstraZeneca COVID-19 vaccine. The country will permit those older than 60 to get the shot. Hungary has been aggressive in its efforts to vaccinate, accepting shipments of China’s Sinopharm and Russia’s Sputnik V vaccines even though neither have been approved by the European Union.
Germany will allow people 65 and older to receive the AstraZeneca COVID-19 vaccine. It is a reversal in a country that was one of the first in Europe to restrict use of the AZ vaccine among the elderly. But new data has supported the effectiveness of the AZ shot, compelling countries to reconsider.
The AstraZeneca vaccine is effective against the Brazilian coronavirus variant, P1, and will not need to be modified to protect against it, according to a study at Oxford cited by Reuters. Earlier results showed that the AZ vaccine was less effective against the South African variant, which is similar to P1. Brazil is suffering through a brutal second coronavirus wave. On Wednesday, the country recorded its daily record of 1,910 deaths.
Takeda has filed a request with Japan’s health ministry to approve Moderna’s COVID-19 vaccine. Takeda is Moderna’s partner for study, importation and distribution of the vaccine in Japan. The country has already approved and begun administering vaccines from Pfizer and AstraZeneca.
Oxford has closed a trial for colchicine, an anti-inflammatory medicine used to combat gout which had been named as a possible treatment for COVID-19. The study provided no convincing evidence that the drug was effective in hospitalized coronavirus patients.
A day after mayor Mike Duggan said that Detroit was “gonna protect Detroiters with a 95% vaccine,” the city has declined 6,200 doses of the Johnson & Johnson COVID-19 vaccine. A spokesman explained later that Detroit has enough vaccines from Moderna and Pfizer to more than cover all of the upcoming week’s appointments. He added that J&J vaccines would be accepted in the next round and that the city would set up a separate site for J&J vaccinations with patients having the option to decline.
As the world battles the coronavirus pandemic, not only are vaccines a precious commodity, so are syringes. In a typical year, 16 billion syringes are used in the world, with only 5% to 10% used for vaccinations. But the global pandemic has brought the need for 8 to 10 billion syringes alone.
Some people are reporting delayed reactions to Moderna’s COVID-19 vaccine, according to the New York Times. The reactions, roughly a week later, can be confused with an infection and include swelling, itchiness, soreness and discoloration.
UPDATED: Thursday, March 4 at 4:03 p.m. ET
A shipment of AstraZeneca COVID-19 vaccines bound for Australia has been blocked by Italy and the European Union because of the company’s failure to meet contractual commitments with Europe. With AZ requesting to export 250,000 doses of the vaccine from a Catalent plant in Anagni, Italy refused and the EU backed the decision.
A large clinical trial by NIH investigating the effectiveness of two monoclonal antibody treatments for hospitalized COVID-19 patients has been halted. One of the studies was for VIR-7831, from Vir Biotechnology and GlaxoSmithKline. The other was a review of BRII-196 and BRII-198 from Brii Biosciences. Both phase 2/3 trials were closed due to futility. Another trial of BRII-196 and BRI-198 will continue with patients who are not hospitalized.
The Government Accounting Office is working with the FDA to solve its growing backlog of inspections, exacerbated by the coronavirus pandemic. Conducting only inspections deemed “mission critical,” the FDA failed to complete more than 1,000 planned inspections last year. Story
Long-haul coronavirus patients are those who experience lingering symptoms for months. But there is some evidence that these patients improve after receiving vaccines. Information is limited and the data is anecdotal but if the pattern holds, it could help experts discover why symptoms persist in some and could offer a path to relief.
UPDATED: Thursday, March 4 at 10:28 a.m. ET
An enormous international database, funded by Google, launched today to track coronavirus cases. The repository at Global.health is more detailed than Johns Hopkins’ COVID-19 dashboard, collecting 40 variables on subjects, such as the date symptoms first appeared, the date of their first positive test and travel history. The data will help researchers discover how rapidly new variants spread, whether vaccines protect against them and how long immunity to the virus lasts.
Pfizer will send 100 million doses of its COVID-19 vaccine to Brazil as the country battles a severe outbreak. With vaccine supplies stretched thin and a homegrown variant surging, Brazil is posting daily records for coronavirus deaths. Contrary to far-right President Jair Bolsonaro’s lead, São Paolo state has issued a partial lockdown.
CureVac has enlisted the help of Novartis to produce its COVID-19 vaccine. Novartis will manufacture the mRNA and bulk drug product at its site in Austria. Delivery is set to start in the summer of 2021 toward a goal of 50 million doses by the end of this year and an additional 200 million doses in 2022. Other vaccine manufacturing partners CureVac has recruited in Europe include Bayer, Fareva, Wacker and Rentschler. Story
The European Medicines Agency has started a rolling review of the Sputnik V adenovirus COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology. A rolling review allows data to arrive as it becomes available and accelerates the approval process.
Two people with preexisting conditions died within days of receiving the AstraZeneca COVID-19 vaccine, triggering an investigation by the Korea Disease Control and Prevention Agency. A 63-year-old nursing home patient with cerebrovascular disease died Tuesday after developing a fever and then being hospitalized with symptoms of blood poisoning and pneumonia. A man in his 50s with a cardiac disorder died on Wednesday after suffering multiple heart attacks a day after receiving the shot. South Korea has vaccinated more than 85,000 with the AZ shot since kicking off the campaign last week.
Partnerships involving drug companies and private foundations have received little scrutiny during the coronavirus pandemic, the BMJ argues. One example is Wellcome Trust, one of the world’s top funders of health research, which holds investments in companies such as Roche and Novartis, which stand to benefit from those funding efforts. The same potential for conflicts of interest exists with the Gates Foundation, the journal said.
UPDATED: Wednesday, March 3 at 3:52 p.m. ET
Anthony Fauci, the government’s top infectious diseases expert, said that the U.S. will continue as planned to vaccinate Americans with both doses of COVID-19 shots from Pfizer and Moderna. There has been a push to quickly vaccinate as many people as possible with one shot. “We’re telling people (two shots) is what you should do,” Fauci told the Washington Post. He said it would be a “messaging challenge” to change course now.
Developing vaccines was the first major step in combating the coronavirus pandemic. Now comes the next and perhaps more daunting challenge: producing and delivering vaccines to the world. Fierce Pharma breaks down the supply-chain efforts of the five vaccine companies leading the charge. Story
The coronavirus pandemic has been a game-changer for Novavax. Entering last year, the company had $80 million in cash and a “financial operating horizon” of six months, according to its CEO. Fast forward to today and Novavax is a major player on the world stage. By midyear, Novavax expects to have the FDA endorsement of its COVID-19 vaccine and the capacity to produce 2 billion annual doses after building a global network of manufacturing sites and partners in 10 countries. Story
Government funding to the tune of $269 million will help Merck upgrade and leverage two of its manufacturing plants in the United States to produce Johnson & Johnson’s COVID-19 vaccine. Some of the funds were secured by way of the Defense Production Act, which helped the Biden administration facilitate the unusual alliance between the pharma giants. Story
An NIH trial of an experimental COVID-19 antibody treatment from GlaxoSmithKline and Vir Biotechnology has been halted because of concerns over its effectiveness. Other tests for the dual-action monoclonal antibody drug remain active, while the NIH study closes enrollment and lets the “data mature.” Vir shares fell 30% with the news, while GSK’s remained stable. Story
Merck isn’t giving up on its COVID-19 medicine, MK-7100. Last week, it was reported that the FDA asked for more data beyond a phase 3 study. Merck is preparing the drug for another go-round. The company picked up the drug when it acquired Oncolmmune late last year and then signed a $365 million deal to provide it to the U.S. Story
German health minister Jens Spahn said that the country’s health watchdog is set to recommend that the AstraZeneca coronavirus vaccine can be given to people older than 65. Germany’s policy of limiting the AZ vaccine to those aged 18-64 has led to a slow uptake of available doses and unused vials. Early this week, France signed off on the AZ shot for those 65 and older. A recent study in Britain concluded that the AZ vaccine is just as effective as the shot from Pfizer–BioNTech.
Polish biotech Mabion has announced a framework agreement to produce antigen for Novavax’s COVID-19 vaccine. It is an initial step toward a potential manufacturing deal between the two which would make Mabion the first Polish firm engaged in supplying coronavirus vaccines to the world.
UPDATED: Wednesday, March 3 at 12:10 p.m. ET
The Biden administration used the Defense Production Act to broker the manufacturing partnership between Johnson & Johnson and Merck & Co., NPR reports. The unusual deal between the pharma giants had been discussed but the administration applied some “implicit” incentive for them to cooperate, according to the report.
The first round of allocations of the COVID-19 vaccine by COVAX were published. The team will ship 237 million doses of the AstraZeneca shot to 142 middle- and low-income countries by the end of May. The Serum Institute of India is the production partner for AZ. The largest allocations will go to Pakistan (14.6 million doses), Nigeria (13.7 million doses), Indonesia (11.7 million doses), Bangladesh (10.9 million doses) and Brazil (9.1 million doses). COVAX will publish a more detailed breakdown of first-round delivery timelines later this week.
In the largest trial ever conducted in India, Bharat Biotech’s COVID-19 vaccine, Covaxin, has shown 81% interim efficacy. Of 25,800 participants, there were 43 virus cases, seven in participants who had been vaccinated. India had already approved Covaxin in January without the phase 3 data, raising questions about its effectiveness. The country has seen a recent surge in cases.
UPDATED: Tuesday, March 2 at 3:22 p.m. ET
The European Union is showing fractures as some members are going outside the bloc in attempts to secure coronavirus vaccines. Leaders from Austria and Denmark, both critical of the EU’s response to the pandemic, will visit Israel this week to discuss options for future vaccine production and supply. Other countries such as Slovakia and Hungary have turned to Russia and China, respectively, for shots that have not been approved in Europe. Only 5.5% percent of the EU’s population of 447 million have received a first shot. The EU’s Committee for Medicinal Products for Human Use will meet virtually on March 11 to evaluate Johnson & Johnson’s COVID-19 vaccine.
Johnson & Johnson will team up with pharma competitor Merck & Co. in an effort to boost production of its COVID-19 vaccine. The Biden administration helped arrange the partnership, according to the Washington Post. Merck will provide two manufacturing facilities in the U.S., one for making the vaccine substance and the other to fill vials. The move gets Merck back into the COVID game after it abandoned two efforts to develop vaccines. Story
The FDA is signing off on coronavirus tests that can be performed or started at home. The two most recently authorized tests are from Quidel and Eurofins. Quidel’s antigen test requires a prescription and can be completed entirely from home. The over-the-counter kit from Eurofins includes a swab and mailing materials, promising a 48-hour turnaround. These are the fourth and fifth at-home tests approved by the FDA since November. Story
An antibody treatment for COVID-19 patients from Cerecor has completed a successful phase 2 trial, showing a 50% reduction in mortality at 28- and 60-day timepoints. Efficacy results were highest in patients older than 60. The small Maryland-based biopharma company will meet with the FDA to discuss a potential path to emergency use authorization. Story
UPDATED: Tuesday, March 2 at 10:51 a.m. ET
A COVID-19 vaccine from Novavax could be available as early as May, according to CEO Stanley Erck, provided that the FDA allows data from a UK. phase 3 trial that showed the shot had 89% efficacy. Speaking on CNBC, Erck said that the UK. regulators will likely review the shot in April. A phase 3 trial that includes 30,000 participants in the U.S. is ongoing. Story
The first shipments of AstraZeneca’s COVID-19 vaccines have begun to arrive in low- and middle-income countries through the COVAX worldwide initiative, the drugmaker announced on Tuesday. Working with manufacturing giant Serum Institute of India, AZ sent vaccines to Ghana and Cote D’Ivoire last week, with shipments to follow to Philippines, Mongolia, Indonesia, Fiji and Moldova. The effort will include 142 countries.
In Britain, vaccines from Pfizer–BioNTech and AstraZeneca are “highly effective” in reducing coronavirus infections and severe illness among the elderly, according to Public Health England. For those 80 and older, a single dose of either vaccine reduced hospital stays of three to four weeks by more than 80 percent. After 35 days of receiving the shot, protection from COVID-19 is actually slightly better with the AZ shot.
In France, AstraZeneca’s COVID-19 vaccine will be available to people ages 65-74 who have health issues that make them vulnerable to the virus, said health minister Olivier Veran. Previously the AZ shot was available in France only to those aged 50-64 with health concerns. People ages 75 and older remain eligible for only the Pfizer and Moderna vaccines.
In Canada, the National Advisory Committee has recommended that the recently endorsed AstraZeneca vaccine not be given to those 65 and older, even after Health Canada authorized its use last week for all adults. The committee recommended that the AZ vaccine should instead be provided to essential workers. Health Canada’s chief advisor Supriya Sharma countered that more information is forthcoming that shows the efficacy rate of the AZ shot may actually be higher than those for the Pfizer and Moderna vaccines.
After weeks of steady decline in COVID-19 cases in the U.S., the trend broke last week, fueling concern of a looming variant wave. According to Bernstein analysts, the break is likely overstated because of a backlog in reporting due to the storm in Texas and a reversion to the mean after a shortened holiday week. Perhaps a better trend indicator was that hospital occupancy continued to decline at the same rate, the analysts wrote. The Bernstein team still warns that the threat of a variant wave is real, but can be neutralized by the expected vaccine supply increase this month.
Hydroxychloroquine, the anti-inflammatory drug once touted by former President Donald Trump, should not be used as a preventative measure against the coronavirus and has no real impact on those already infected, said the World Health Organization. The “strong recommendation,” from a WHO expert panel, was based on six trials including 6,000 participants both with and without exposure to COVID-19.
UPDATED: Monday, March 1 at 3:05 p.m. ET
Amid J&J‘s coronavirus vaccine rollout, the company and health officials are setting out to convince Americans about the shot’s value. CEO Alex Gorsky and former FDA commissioner Scott Gottlieb took to the media to explain the value of the J&J vaccine and why efficacy rates of the shot had little chance to measure up to those of Pfizer and Moderna, which were tested under much different circumstances. On CNBC, Gorsky said, “Our data actually includes these most challenging, pernicious, virulent strains and what we saw was an 85% effectiveness rate in the severe disease.” Story
With the goal of delivering 20 million doses by the end of March and 100 million by the end of June, Johnson & Johnson is seeking manufacturing partnerships to increase supply, CEO Alex Gorsky told Bloomberg. J&J’s manufacturing network extends to Europe, Asia and Africa. The company hopes to have eight facilities operating by midyear. “One of our facilities was literally a parking lot 12 months ago,” Gorsky said. “Today it’s one of the most advanced biopharmaceutical vaccine manufacturing facilities in the world. We’re learning along the way.” Story
By cashing in its 7.65% stake in Moderna at an undisclosed point last year, AstraZeneca made approximately $1 billion, the British pharma revealed in its annual report. Over the years, amid several strategic collaborations, AZ had invested more than $290 million in Moderna. When Moderna’s value surged with the development and rollout of its COVID-19 vaccine, AZ was positioned to profit. During the year, Moderna’s share price swelled from just under $20 to $160. Story
Flowserve, a manufacturer of industrial and environmental machinery, is providing pumps, valves and seals to Pfizer for its production of the COVID-19 vaccine. During engineering runs of vaccine production, Pfizer needed immediate support to replace a mechanical mixer seal on its production line. Flowserve will supply Pfizer with more than 200 Worcester cryogenic ball valves that can handle the extreme temperature requirements needed during the manufacturing process.
UPDATED: Monday, March 1 at 10:32 a.m. ET
Johnson & Johnson’s COVID-19 vaccine scored emergency authorization from the FDA for individuals 18 and older. It’s the third coronavirus vaccine approved by the U.S. after regulators signed off on shots from Pfizer–BioNTech and Moderna in December. The nod “expands the availability of vaccines, the best medical prevention method for COVID-19 , to help us in the fight against this pandemic, which has claimed over a half a million lives in the United States,” acting FDA commissioner Janet Woodcock said in a statement. Story
Johnson & Johnson will test its coronavirus vaccine in children and infants. The news emerged from a briefing document from Friday’s FDA advisory committee meeting, which led to approval of the vaccine. J&J will first test the vaccine in children age 13-17, then move on to adolescents and newborns. Those studies will be followed by testing of pregnant women and those who are immunocompromised. Dr. Ofer Levy of Harvard’s Boston Children’s Hospital and the FDA advisory committee said news of testing infants “turned my head.”
Europe’s drug regulator has provisionally approved Regeneron’s antibody drug for COVID-19 patients who do not require oxygen. The monoclonal antibody therapy was authorized for emergency use in the U.S. in November and was administered to former President Donald Trump.
The Serum Institute of India is under audit by Europe’s drug regulator before allowing AstraZeneca to produce COVID-19 vaccines there for import to the EU, a source told Reuters. This comes after reports last month of the UK. doing the same at Serum. The EU generally is supplied by local facilities, but production problems have reduced deliveries of the AZ vaccine. The European Medicines Agency has been auditing the Serum plant for a week and could be done in March.
Prime ministers of three German states said Sunday that unused COVID-19 vaccinations from AstraZeneca should be offered to people ages 18-64. Germany has opened vaccinations only for front-line and essential workers and people 65 and older. But with many rejecting the AZ shot and only 15% of the AZ supply used, there is a push to relax the prioritization scheme.
Israeli prime minister Benjamin Netanyahu said he is in discussion with COVID-19 vaccine producers Pfizer and Moderna to open plants in his country. “I am negotiating with them to build plants in Israel that will turn Israel into an international center in the fight against coronavirus,” he said. “I want to be in a situation where the Right, the Left, Arabs, Jews … I want them all to get vaccinated and I want to ensure they have the vaccines they require in the future.”
McKesson, selected by the U.S. government as the distributor for frozen and refrigerated coronavirus vaccines and the supply kits to administer them, has begun distributing recently authorized Johnson & Johnson COVID-19 vaccine. McKesson has four distribution centers in the U.S. The government makes all decisions on how many doses McKesson will distribute. McKesson did the same for the Moderna vaccine rollout in December. It also provided the ancillary supply kits for the Pfizer–BioNTech vaccine, but not the ultra-cold storage and distribution.
A Chinese state-backed hacking group has been targeting two Indian vaccine makers according to cyber intelligence firm Cyfirma. The hacking group, Stone Panda, has identified vulnerabilities in the IT infrastructure and supply chain software of Bharat Biotech and the Serum Institute of India. China and India are rivals in their effort to supply COVID-19 vaccinations domestically and worldwide. SII is producing the AstraZeneca vaccine for many countries and soon will begin manufacturing Novavax shots.
UPDATED: Friday, Feb. 26 at 3:57 p.m. ET
The FDA will allow the COVID-19 vaccine from Pfizer–BioNTech to be stored above subzero temperatures for up to two weeks. The move will simplify delivery of the vaccine, which previously needed to be kept at minus 112 to minus 76 degrees Fahrenheit. It also will allow for more access to the shot in rural areas of the U.S. and in lesser-developed countries, which often lack cold storage equipment. Story
Merck’s deal to supply its experimental COVID-19 drug, MK-7110, has been voided after U.S. regulators asked the German drugmaker for additional data beyond a phase 3 study. In its annual report, Merck had already said it no longer expects to supply the U.S. with the treatment for patients hospitalized with severe cases of the virus. Merck inherited the drug when it acquired Oncolmmune late last year and then signed up to supply it to the U.S. Story
AstraZeneca CEO Pascal Soriot responded to criticism that the drugmaker is lagging in delivering promised supplies of COVID-19 vaccines. Speaking remotely at a European Parliament hearing, Soriot said AZ would deliver 40 million doses to Europe by the end of the first quarter and is working to increase production. “Whether you manufacture cars, planes or indeed vaccines, you often have issues with manufacturing,” he said. “Typically in our industry we have years to refine the process. Here we didn’t have that time, we didn’t have that luxury. We had six months.”
Add another COVID-19 vaccine to Canada’s list of approved shots. With the authorization of AstraZeneca’s jab, Canada has three approved vaccines, along with those from Pfizer and Moderna. By the end of March, Canada will now have 6.5 million doses to distribute among its population of 38 million. While some countries, including France, have limited the AZ vaccine to those under 65, Canada will allow it for the elderly.
Doctors Without Borders has made an appeal to Johnson & Johnson to make its first shipments of COVID-19 vaccine to COVAX for low- and middle-income countries. The J&J shot is on the verge of approval in the U.S. Last week, U.N. Secretary-General Antonio Guterres criticized the distribution of vaccines as “wildly uneven and unfair,” saying 10 of the world’s countries have administered 75 percent of the shots, while 130 countries have yet to receive a single dose.
A coronavirus variant first discovered in California is more contagious than earlier forms of the virus, according to two studies. This strain produces twice as many viral particles and may be more resistant to vaccines. Since its discovery in late December, researchers have found traces of the variant in 45 states and several other countries, but it’s only spread significantly in California.
UPDATED: Friday, Feb. 26 at 11:38 p.m. ET
Regeneron received a thumbs up for its COVID-19 antibody treatment from the Independent Data Monitoring Committee in an ongoing late-stage trial and will follow its recommendation to stop enrolling patents in the placebo group. The committee found that the drug reduces rates of hospitalization and fatalities.
During an interview on CNBC, former FDA commissioner Scott Gottlieb, now a board member at Pfizer, explained how the company is researching two methods to provide protection against emerging coronavirus variants. The first is a booster shot using the current vaccine formula, while the second approach involves modifying the existing vaccine to provide stronger immunity against mutations.
With Johnson & Johnson’s COVID-19 vaccine on the verge of approval in the U.S., the Washington Post poses the question: Which vaccine is the best, Pfizer’s, Moderna’s or J&J’s? The consensus answer from experts: The vaccine you can get first. While efficacy rates in clinical trials do not favor the single-shot J&J vaccine, the difference isn’t enough to compensate for the value of getting any of the shots first. The more people who get vaccinated, “the lower everybody’s risk becomes, regardless of which vaccine you get,” said Joshua Barocas, an infectious disease doctor at the Boston Medical Center.
The United States has agreed to buy a minimum of 100,000 doses of Eli Lilly’s antibody treatment. The drug recently received emergency authorization for recently diagnosed, mild to moderate COVID-19 patients who are at a high risk of progressing to severe disease. The government will pay $210 million for this order, with an option to purchase 1.1 million more doses by the end of November. The U.S. is providing antibodies at no out-of-pocket cost to patients, though healthcare facilities may charge an administration fee. Story
Regeneron and Roche announced that the European Medicines Agency has issued a positive opinion on their antibody treatment for COVID-19 patients who do not require oxygen. This is a key step in the approval process. While Regeneron is handling development and delivery of the drug in the U.S., Roche is doing the same internationally.
UPDATED: Thursday, Feb. 25 at 4:15 p.m. ET
Moderna has already secured $18.4 billion in advance purchase agreements for COVID-19 vaccines this year, the company reported. The figure is a substantial increase on what the company reported last month ($11.7 billion) for its 2021 advance purchase agreements. Moderna’s effort to rapidly produce and deliver vaccines has been a game-changer for the Cambridge, Mass. company. In all of 2019 Moderna generated $60 million in revenue. In the final quarter of 2020 alone, it racked up $571 million. Story
AstraZeneca will “make use of its global capacity,” said a company spokesman, to supply Europe with 180 million doses of promised coronavirus vaccine. The British-Swedish drug company has received sharp criticism from the EU for failing to meet delivery milestones and issuing warnings that more manufacturing problems could lead to shortfalls in the second quarter. AZ plans to fulfill its pact with the EU with equal parts contributions from its European and overseas supply lines. Story
“Mission Possible” is a movie-length product placement that chronicles how Pfizer and BioNTech developed their COVID-19 vaccine and brought it to the market. National Geographic‘s branded content group was granted near-unfettered access to produce the film, which premieres on its network on March 11, the one-year anniversary of the World Health Organization’s declaration of the pandemic. Story
South Korea drugmaker SK Bioscience will launch an initial public offering next month, expecting to raise $900 million, much of which has been earmarked for factory expansion and vaccine R&D. The move comes shortly after SK Bioscience agreed to produce 40 million COVID-19 vaccines for Novavax. Story
Altimmune has developed a single-dose, needle-free, intranasal COVID-19 vaccine soon to enter phase 1 testing, the company said in a release. The Maryland-based drugmaker touts AdCOVID as a treatment that targets the virus at its point of entry. It is designed to stimulate a broader immune response, both systemically and locally. Mucosal immunity in the nasal cavity is believed to be crucial in blocking transmission of the virus.
UPDATED: Thursday, Feb. 25 at 11:25 a.m. ET
A study of the Pfizer–BioNTech coronavirus vaccine in Israel shows the shot is highly effective, cutting cases by 94% across all age groups. Conducted by the Clait Research Institute, this was the first real-world study of this scale, differentiating it from the controlled conditions found in clinical trials. Clait compared results for 600,000 participants who had received the shot with 600,000 people who had not. The result was nearly identical to the two-dose efficacy rate (95%) registered in trials last year. Story
The U.S. will undertake a review of supply chains after President Joe Biden issued an executive order designed to bolster domestic production of critical goods including pharmaceuticals. The move is designed to build self-reliance and resilience for an economy that has been stressed by the coronavirus pandemic. Few details emerged on how it will impact the pharmaceutical industry but it could be a step toward “onshoring” drug manufacturing, an initiative that was stoked by pandemic-related lockdowns and geopolitical tension, which created supply-chain uncertainty.
The U.S. should approve the AstraZeneca vaccine as soon as possible, said Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital. Speaking on CNBC, Hotez said that due to the threat of overseas variants, Americans should not get complacent about the nation’s 57% drop in cases. “We’re all high-fiving ourselves because the numbers are going down,” Hotez said. “I’m saying we are in the eye of the hurricane and the next big wave is coming.”
An online scam selling fake COVID-19 vaccines has landed three men from the Baltimore area in jail. The website announced in capital letters, “You may be able to buy a Covid-19 vaccine ahead of time,” and offered shots priced at $30 each from Moderna. This is just one of many schemes that have emerged since the start of the pandemic. The Department of Homeland Security has seized roughly $33 million in proceeds and analyzed nearly 80,000 COVID-19 dominion names, according to an agency spokeswoman.
With the addition of a COVID-19 antibody treatment from South Korea drugmaker Celltrion, Europe’s regulator now has three such antibody therapies under review. Earlier this month, the European Medicines Agency began evaluating antibody drugs from Eli Lilly and Regeneron. After Celltrion’s antibody drug was shown to cut recovery time, South Korea conditionally approved it in November.
Actresses Angela Bassett and Rosie Perez, rapper Daveed Diggs and Fintech Zoom medical expert Sanjay Gupta will appear in radio, TV and social media advertisements urging people to get coronavirus vaccines. The campaign is designed to combat hesitancy about the safety of vaccines, with an emphasis on reaching Black and Hispanic Americans, who have been more impacted by the virus.
UPDATED: Wednesday, Feb. 24 at 2:07 p.m. ET
Johnson & Johnson’s vaccine is safe and effective, FDA staffers said in briefing documents released ahead of Friday’s advisory committee meeting. The documents confirmed that J&J’s single-dose shot was 66.1% effective at preventing infection at least 28 days after vaccination, with “no specific safety concerns identified that would preclude issuance” of an emergency authorization. Besides preventing infection altogether, the shot was 85% effective at staving off severe disease and helped keep patients out of the hospital. Story
The World Health Organization’s equitable vaccine distribution scheme Covax kicked off its global rollout with the delivery of 600,000 AstraZeneca doses to Ghana. AZ’s manufacturing partner Serum Institute of India is tackling production for the effort, which is co-led by Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI). Covax deliveries to Abidjan and Cote d’Ivoire are also expected this week. The facility hopes to deliver at least 2 billion COVID-19 vaccine doses by year-end.
Germany has administered a slim 15% of the AstraZeneca vaccines it has on tap, the country’s health ministry said. The shot has faced skepticism from the German public after trial results placed the vaccine’s efficacy below competitors’. Meanwhile, Chancellor Angela Merkel’s spokesman has said that shot is safe and effective, calling for the public to put its faith in the shot.
Contract research organization PPD, heavily involved in trials for COVID-19 vaccines—including Moderna‘s authorized mRNA shot—saw income jump to $1.36 billion in the fourth quarter, marking a 30.3% increase over the $1.04 billion it pulled during the same period in 2019. Clinical development services, up up 28.3% on the year-ago period, and laboratory services, up 40.1%, helped drive that growth. Overall, PPD raked in $4.68 billion for the year, up 16.1% from 2019, despite withdrawing its guidance in 2020’s first quarter as COVID-19 hamstrung the CRO industry. Story
The Philippines is offering to send more healthcare workers to Germany and the UK. in exchange for vaccine doses, but the UK. has declined and Germany has yet to respond, Reuters reports. The Philippines limits the number of healthcare workers deployed overseas to 5,000 a year, but it would be willing to lift the cap to trade for COVID shots, Alice Visperas, director of the Filipino labor ministry’s international affairs bureau, said. The UK. says it isn’t interested, but reiterated its pledge to donate surplus vaccines to other countries in the future.
UPDATED: Wednesday, Feb. 24 at 11:02 a.m. ET
The European Union could face supply shortages of AstraZeneca‘s COVID-19 vaccine extending into the second quarter of this year.The company warned EU officials of continuing problems at a factory in Belgium that is producing the shot. But EU president Ursula von der Leyen said she’s optimistic that supply shortfalls can be remedied. AZ remains hopeful that it can compensate for any shortfall by the third quarter. Overall, AZ’s total supply to the EU by late June could reach 130 million doses, far short of the promised 300 million. Story
The FDA will approve Pfizer and BioNTech’s request to store their COVID-19 vaccine at standard pharmacy temperatures instead of ultra-cold freezers, according to the New York Times. The move modifies guidance, issued when emergency authorization was granted for the shot in December, which required it to be stored at temperatures between -80 and -60 degrees Celcius.
The NIH will study how pregnant COVID-19 patients metabolize and tolerate remdesivir. The Gilead Sciences antiviral drug, approved last summer for coronavirus patients with pneumonia who required oxygen, has since gained wider use. The study will take place in 17 U.S. cities and will compare remdesivir use in pregnant and non-pregnant patients of reproductive age who are hospitalized with COVID-19.
The case history of a deceased UK. COVID-19 patient who had received chemotherapy for lymphoma has given experts a better idea of how coronavirus variants may arise in people with compromised immune systems. The study reveals how selective pressures bring about viral mutations, according to Ravindra Gupta of Cambridge University’s medical team. The case “has been transformative of understanding what’s going on with this disease,” Gupta told Scientific American.
In response to reports of Germans refusing AstraZeneca’s COVID-19 shot because of side effects—and vials of it going to waste as a result—EU president Ursula von der Leyen said she would take the vaccine “without a second thought, just like Moderna’s and BioNTech/Pfizer’s products.” Her remarks, to the Augsburger Allgemeine, come amid growing frustration over the lagging pace of AZ’s vaccine supply to the EU and suggestions, denied by the company, that the British-Swedish company has given supply preference to the UK., where more than a quarter of the population has been vaccinated.
The HHS will no longer allocate doses of COVID-19 antibody drugs from Eli Lilly and Regeneron because scarcity is no longer an issue. The drugs will remain free, according to a release from the American Hospital Association, and can now be ordered directly from AmerisourceBergen, the sole distributor of antibody drugs.
China’s fourth domestically-developed COVID-19 vaccine may soon be available. Sinopharm and CanSinoBIO have registered their vaccine for authorization. The treatment was previously approved for emergency use last July for those with a higher infection risk. It is the second Sinopharm vaccine. The first was approved in December. China has yet to approve any overseas vaccines for domestic use.
UPDATED: Tuesday, Feb. 23 at 4:32 p.m. ET
Pfizer is eyeing price hikes for its COVID-19 vaccine after the pandemic, according to a top company executive. On an earnings call this month, CFO Frank D’Amelio said Pfizer is “going to get more on price” after what he termed the “pandemic pricing environment.” Pfizer, which was first to the market in the COVID-19 vaccine race, is charging the U.S. $19.50 per dose. By comparison, Pfizer’s pneumococcal vaccine Prevnar 13 fetches more than $200 per dose on the private market. Story
According to a study by Merck KGaA, the coronavirus pandemic has put increased stress on unpaid caregivers. Surveying 9,000 people in 12 countries, Merck found that caregivers are facing added physical, mental and financial burdens. The pandemic has forced 20% of caregivers into first-time roles. Caregivers are spending 23 hours per week on average tending to their loved ones, an increase of more than seven hours from before the pandemic. In addition, 22% say they’ve had to reduce their paid hours due to caregiving responsibilities. Story
The FDA told vaccine makers on Monday that large clinical trials to assess the effectiveness of authorized shots against coronavirus variants are not necessary. New guidance from the FDA suggests smaller trials “that compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine” are sufficient to determine the effectiveness of the modified vaccine.
The coronavirus pandemic may force Novartis India to lay off roughly 170 people. The proposed cuts would be to the pharmaceutical segment of Novartis, a senior executive told The Times of India. The India arm of the Swiss drug giant reported a net loss in the fourth quarter of last year after posting profits in the same quarter of 2019.
UPDATED: Tuesday, Feb. 23 at 11:12 a.m. ET
Pfizer and Moderna will tell Congress today of their plans to increase supplies of their respective COVID-19 vaccines for the United States. Thanks to manufacturing overhauls, Pfizer expects by mid-March to be delivering 13 million doses of COVID-19 vaccine per week. The increase puts Pfizer on track to provide 120 million doses by the end of March and meet its pledge of 300 million by the end of July. Moderna is on a similar trajectory, expecting to have delivered 100 million doses by the end of March on its way to 300 million by the end of July. In addition, Johnson & Johnson, whose single-shot vaccine is set for review Friday by the FDA, is prepared to deliver 20 million doses by the end of March. Story
Aridis has updated its investigational COVID-19 monoclonal antibody treatment, AR-711, to neutralize emerging variants of the virus. The new version, AR-713, will begin clinical trials in the second half of this year. AR-711 is an inhaled drug for COVID-19 patients who are not hospitalized. According to Aridis, AR-713 has been shown to neutralize the South African variant as well as the Brazilian and Japanese strain, while also negating the original COVID-19 strain and its UK. variant.
COVID-19 patients in Europe who do not need oxygen support may later this year be treated with remdesivir, Gilead’s antiviral drug. The European Medicines Agency is evaluating data from Gilead and could issue an opinion by the summer. Europe approved the drug last July for coronavirus patients 12 and older who had pneumonia and required oxygen. Earlier this month, Gilead predicted sales of $3 billion for the drug this year.
The FDA has issued new recommendations for drugmakers to address the impact of emerging COVID-19 variants on their products. In a press conference FDA commissioner Janet Woodcock said, “We need to identify efficient ways to modify the products that are either in the pipeline or are EUA products to address these variants.” Woodcock emphasized that treatments must be monitored to ensure that if performance is altered, the FDA and manufacturers are made aware.
With supplies lacking and amid public resistance to the AstraZeneca COVID-19 vaccine, Germany is adjusting its inoculation strategy. With the reopening of schools, which have been closed since November, teachers will get priority access to the AZ shot. Next in line are police officers and members of the army. This comes after many front-line health workers refused the AZ shot amid reports of side-effects. Germany has administered 5 million vaccine doses, which accounts for 6% of its population, lagging behind the UK. and U.S.
Clover Biopharmaceuticals has raised $230 million in a round of oversubscribed Series C financing, which brings the China-based company’s total capital raised in the last 12 months to more than $400 million. In part, the proceeds will support Clover’s continued development of its COVID-19 vaccine and production planning for potentially hundreds of millions of doses this year. Clover will initiate a global phase 2/3 efficacy trial for its vaccine in the first half of this year. Story
UPDATED: Monday, Feb. 22 at 3:35 p.m. ET
Sanofi signed a deal to manufacture Johnson & Johnson’s coronavirus vaccine. The plant in France will produce 12 million doses of the J&J vaccine per month. The deal comes after another Sanofi agreement to make 100 million doses of the Pfizer–BioNTech vaccine this year. Story
Also from Sanofi, the company has not given up on its own effort to develop a COVID-19 vaccine. Sanofi and its partner GlaxoSmithKline said they are starting a phase 2 study of their second try at a shot, which combines Sanofi’s recombinant protein-based vaccine with GSK’s adjuvant. After weak early results forced them to retool, this version offers an “improved antigen formulation,” the company said. If the trial is successful, it would clear the way for phase 3 testing in the spring and production of doses before year-end. In another partnership, Sanofi and Translate Bio are working on an mRNA vaccine that’s set to enter testing next month. Story
Eli Lilly CEO David Ricks was paid $23.7 million last year, an 11% increase on his 2019 compensation, according to a recent proxy filing. The figure likely places Ricks among the world’s highest-paid pharma execs for 2020. His lucrative package reflects a successful year for the Indianapolis-based pharma, which earned emergency authorization for multiple COVID-19 therapies in addition to notching first-time approvals for cancer drug Retevmo and mealtime insulin Lyumjev. In the fourth quarter last year, Lilly rang up $871 million in antibody revenue. Story
Novavax’s COVID-19 vaccine is ranked No. 2 on the Fierce Pharma list of the 10 most-anticipated drug launches of 2021. The list is ranked by predicted global sales for 2026 as compiled by Evaluate. The only drug ranking ahead of Novavax’s vaccine is aducanumab, an Alzheimer’s therapy from Biogen that is estimated to score $4.8 billion in sales in 2026. Novavax’s COVID-19 vaccine sales are expected to hit $2.73 billion the same year. In January, Novavax reported 89% efficacy in a phase 3 trial in the UK. Results in South Africa (60%) were less encouraging, but those were chalked up to the emergence of the coronavirus variant there. Novavax believes that its approach, delivering adjuvanted fragments of the spike protein made in insect cells, is well suited to the evolving virus, and analysts agree. Story
The Serum Institute of India has been instructed by government officials to meet domestic demand for its COVID-19 vaccine—produced under license from AstraZeneca—before supplying doses of the shot overseas. The announcement by Serum CEO Adar Poonawalla suggests that foreign countries are likely to face supply delays, just days after news emerged that UK. officials were auditing the company’s manufacturing ahead of potential vaccine imports. The AstraZeneca shot was approved this month by the World Health Organization, clearing the way for supplies to low- and middle-income countries. Story
UPDATED: Monday, Feb. 22 at 10:50 a.m. ET
Within the next few weeks, Pfizer will double its coronavirus vaccine supply to the U.S., said CEO Albert Bourla. Speaking Friday afternoon after President Joe Biden toured Pfizer’s factory in Portage, Michigan, Bourla said improvements at the plant had reduced the time needed to produce its shot to 60 days from 110 days. As of Feb. 17, Pfizer had supplied the U.S. with 40 million doses. Pfizer’s current supply rate is 5 million per week. The company has promised 300 million doses to the U.S. by the end of July.
FDA review documents due for release this week will give the agency’s infectious disease panel feedback for their upcoming review of the Johnson & Johnson COVID-19 vaccine. The document release—and Friday’s advisory committee meeting and vote—are key steps in the approval process. Late last year, vaccines from Pfizer and Moderna each gained emergency authorization one day after their respective FDA reviews. This time, though, could be more complicated because the panel will also assess the J&J vaccine’s efficacy against new virus variants. The J&J shot has advantages: It doesn’t have to be stored at ultra-cold temperatures, and one dose is required instead of two. But the vaccine has shown less potency against the South African variant.
In Belgium, cargo volume at Brussels Airport was up 21% percent in January due largely to its role as an export hub for the Pfizer–BioNTech COVID-19 vaccine. Since the end of November, airlines leaving Brussels have flown Pfizer vaccines to more than 40 destinations, some as far away as Tokyo, per an announcement last week by DHL and All Nippon Airways. The cargo increase at Brussels has helped the facility compensate for a sharp decline in passenger traffic, which was down 84% compared to January of last month.
Former FDA commissioner Scott Gottlieb said the U.S. may never reach herd immunity. Speaking Sunday on “Face the Nation,” Gottlieb said that the drop in infections across the country this month is an encouraging sign that will likely continue. But when asked about vaccinating children, he said, “I don’t really think we’re ever going to reach full herd immunity. This isn’t going to be like measles or smallpox, which just sort of goes away. COVID is going to continue to circulate at a low level.” As of Feb. 18, the rolling average for new infections had fallen 43% in the U.S. in two weeks.
Novavax announced it had wrapped up enrollment in Prevent-19, its phase 3 vaccine study in the U.S. and Mexico. The trial in 30,000 participants emphasizes diversity, including LatinX (20%), African American (13%), Native American (6%), Asian American (5%) and adults 65 years and older (13%) participating.
Dynavax and the Serum Institute of India announced they had dosed their first patients in a clinical trial of their partnered COVID-19 vaccine, adjuvanted with CpG 1018. The phase 1 portion will enroll 39 healthy volunteers, with 216 subjects on tap for phase 2. CpG 1018 is used in Heplisav-B, a hepatitis B vaccine which provides an increased vaccine immune response.
Vaccines use in Scotland reduced the risk of hospitalization by as much as 94% after four weeks of the first shot, a real-world study found. Experts compared people who have received a first dose against those who hadn’t. Those vaccinated with the AstraZeneca jab had a reduced hospitalization risk of 94%, while those who received the Pfizer vaccine saw an 85% reduction. In the high-risk 80-plus age group, hospital admission was reduced by 81% four weeks of receiving the shot.
UPDATED: Friday, Feb. 19 at 4:15 p.m. ET
New studies show that people who have had the coronavirus should still be vaccinated. One dose of vaccine can stoke antibodies, vanquishing the virus and even some of its potent variants. The latest study, which analyzed blood samples of those who have had COVID-19, indicate that they would have trouble fending off the B.1.351 strain from South Africa. But one dose of a Pfizer or Moderna vaccine boosted antibodies by a thousandfold.
In a Harris Poll survey this month, 62% of Americans gave the pharmaceutical industry a positive rating as opposed to 32% the same time last year. The poll shows pharma’s typically poor reputation has improved during the pandemic as companies worked proactively and collaboratively to develop vaccines and rush them to market. Respondents rate the industry on a scale of 1-7; In January of 2020, only 32% assigned a rating of 5, 6 or 7. This month 62% did so. Story
Other pharma companies have beaten Novavax to the punch in rolling out COVID-19 shots. But the Maryland drugmaker landed a roundhouse blow on Thursday, agreeing to supply 1.1 billion doses of its yet-to-be authorized COVID-19 vaccine. Novavax made the deal with Gavi, the Vaccine Alliance, and COVAX, which are working on equitable worldwide distribution of COVID-19 vaccines. Novavax will itself provide vaccines for high-income markets while the Serum Institute of India will supply other countries under a no-cost license. Story
The coronavirus pandemic was the dominant theme in the pharmaceutical industry in 2020. But GlobalData’s review of the top 10 companies by market cap revealed that the fortunes of many were not tied to their COVID-19 performance. While AbbVie had the largest market cap increase (44.3%) over the course of the year, despite a lack of COVID-19 products, big-time vaccine providers Pfizer and AstraZeneca failed to beat their pre-COVID market valuations. Other companies, however, such as Eli Lilly, Roche and Johnson & Johnson, parlayed their COVID successes into market cap growth. Story
Novartis CEO Vas Narasimhan saw his pay decrease from $11.61 million to $11.44 million in 2020, due largely to a pandemic-driven shortfall in sales. Narasimhan’s base salary increased by 5.5% last year, but a bigger decline in his annual bonus accounted for the overall compensation drop. Story
Pfizer provided data to the FDA showing its coronavirus vaccine can be stored at higher temperatures than previously known, which would allow pharmacies greater flexibility in managing their vaccine supplies. Now, the vaccine must be stored at temperatures between -80 and -60 degrees Celsius for up to six months—temperatures that require special, ultracold freezers. But Pfizer‘s new data show it can withstand storage at temperatures of -25 to -15 degrees Celsius, meaning standard pharmaceutical freezers would be suitable—provided the agency approves a label change.
The United Kingdom’s National Health Service established a social media effort designed to bolster confidence in the nation’s coronavirus vaccine push. On Friday, social media users gained access to an array of Facebook frames and Instagram GIFs that show “I’ve had my vaccine” or “I will get my vaccine.” The messages will be available in 13 languages by Feb. 22.
German health officials are emphasizing the safety of the AstraZeneca COVID-19 vaccine amid reports that thousands of essential workers are rejecting the shot because they’re afraid of side-effects. Like most European countries, Germany does not offer a choice of vaccine. As a result, many are skipping appointments and several hundred vials have gone unused.
President Joe Biden will travel to Michigan on Friday to tour a Pfizer manufacturing facility that’s cranking out COVID-19 vaccines. Biden is expected to discuss with Pfizer officials how employing the Defense Production Act can help the company quickly produce and distribute more vaccines. Pfizer has committed to supply 100 million doses by the end of March and a total of 300 million by the end of July.
South Korea announced it will spend $237.1 million to develop COVID-19 treatments and vaccines. The goal is to have a local vaccine developed by early next year. “Even though we will start COVID-19 vaccination soon, we have to secure our capacity to prepare (for) new infectious diseases in the long term,” said health and welfare minister Kwon Deok-cheol.
UPDATED: Thursday, Feb. 18 at 4:13 p.m. ET
Typical side effects of COVID-19 vaccines are fever, fatigue, nausea and headaches. But there is fear in some European countries that the effects are more prevalent with the AstraZeneca vaccine, the last of three to be authorized in Europe. In France, health authorities have ordered administration of the shot to be staggered to limit the potential impact on healthcare services. In Germany, some essential workers have refused the shot. In two regions in Sweden, vaccinations have been put on hold. Story
Pfizer and BioNTech‘s vaccine trial in pregnant women will include approximately 4,000 participants in the U.S. Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the UK. The women must be 18 years or older and 24 to 34 weeks into their pregnancy. The first doses have already been administered in the U.S. The study will assess the safety in infants of vaccinated pregnant women and potential transfer of antibodies to infants.
Approval of the Johnson & Johnson vaccine is expected in early March, but there will be only a “few million” doses available right away, according to coronavirus response coordinator Jeffrey Zients. Johnson & Johnson’s contract with the government calls for 100 million doses to be delivered by the end of June. White House chief medical advisor Anthony Fauci expressed his disappointment at the low numbers, but also said that he expects a significant increase from J&J in the spring. Story
The Belgian plant blamed for AstraZeneca‘s vaccine delivery shortfalls in Europe has undergone recent changes. Last month, Thermo Fisher acquired it as part of a $878.2-million buyout of Novasep’s viral vector manufacturing business, just a few months after Novasep identified the site for production of the adenovirus vector for AstraZeneca’s vaccine. Now, production capacity at the plant has “drastically” increased, EU industry commissioner Thierry Breton said. Story
UPDATED: Thursday, Feb. 18 at 11:26 a.m. ET
After two Canadian researchers recommended officials delay the second dose of Pfizer‘s vaccine, Pfizer responded, saying it has not evaluated alternative dosing regimens and that it’s up to health authorities to decide. Some countries, facing supply shortages, are considering dosing patterns that vary from how the vaccines were tested in trials. In their letter to the New England Journal of Medicine, the researchers also cited the first-dose efficacy of Moderna’s vaccine (92.1%). They added that while there is uncertainty about the duration of protection with a single dose, a second dose a month later provides “little added benefit in the short term.”
In another Pfizer study, which was published in the New England Journal of Medicine, scientists developed an engineered virus that contained the same mutations carried on the spike portion of the COVID-19 variant found in South Africa. Researchers tested the engineered virus against the blood from those given the vaccine and found a two-thirds reduction in neutralizing antibodies compared with its effect on the original version of the virus. Story
Johnson & Johnson has only a few million doses of its COVID-19 vaccine in its inventory, White House officials said. The company has committed to providing 100 million doses by the end of June, part of an agreement with the U.S. federal government. The pact carries an option for the U.S. to buy 200 million more doses. An FDA panel will review the J&J vaccine on Feb. 26. Story
Developing and selling coronavirus drugs and vaccines has produced a windfall for some in the drug industry, but the success isn’t always reflected in their stock prices. For example, giants like Pfizer and Gilead are down roughly 20% from their pandemic highs, placing them in contrast to smaller vaccine developers like BioNTech, Moderna and Novavax, whose share prices have performed much better. The Wall Street Journal explains why.
German health officials are battling a perception that the AstraZeneca COVID-19 shot is a “second-class vaccine.” Concern has been fueled by reports of fevers and headaches from those who have been inoculated. After EU regulators gave the AZ shot a limited approval, Germany has provided the vaccine only to those under age 65.
French drugmaker Valneva‘s COVID vaccine likely won’t score an approval until the final quarter of 2021, the company says, but many investors are still betting on the company. Why the optimism? Valneva is the only drugmaker in Europe or the U.S. working on an inactivated shot which stimulates an immune response by injecting a coronavirus sample that has been killed, a route used in the development of many other vaccines. As a result, Valneva’s shot has simpler storage requirements.
Billionaire Bill Gates said that vaccines developed by Novavax and Johnson & Johnson, which have yet to be approved in the U.S., will still be essential in the coronavirus fight, despite their weaker performance against a new variant of the virus identified in South Africa. Gates, whose foundation has donated millions of dollars to coronavirus research and treatment, told CNBC that “there is reduced efficacy, although Novavax and Johnson & Johnson still retain a lot of capability against those variants.”
Avigan, an antiviral drug from Fujifilm, has little benefit for COVID-19 patients once their symptoms become serious. Nine clinical trials revealed that the drug, known generically as favipiravir, helped patients in the early stages of their hospitalization but didn’t reduce mortality among those with mild to moderate cases.
The RECOVERY Trial, the world’s largest clinical trial for coronavirus treatments, has expanded internationally with the addition of Indonesia and Nepal. The trial, which was launched in the UK., has enrolled more than 36,000 patients and produced results that have already altered clinical care, reducing the risk of those hospitalized.
UPDATED: Wednesday, Feb. 17 at 4:31 p.m. ET
Alongside Pfizer, which has pledged 200 million more vaccine doses to the EU, Moderna will provide an additional 150 million doses to be delivered in the third and fourth quarters of this year. This brings Moderna’s supply commitment to the EU up to 310 million doses by the end of 2021. Story
Inconsistent manufacturing of AstraZeneca’s COVID-19 vaccine for clinical trials against the South African variant may account for the trial’s results, according to a note from SVB Leerink analysts on Wednesday. The analysts wondered if the FDA would raise concerns over manufacturing during the vaccine’s U.S. review. Story
A factory in Mexico will not be able to produce AstraZeneca’s COVID-19 vaccine until early April, the country’s foreign minister said. Shipments of the active ingredient used to make the vaccine have already arrived, but a complex certification process has held up production. Mexico has already begun receiving the first of 2 million doses of the AstraZeneca vaccine from India.
In a trial of Roche’s Actemra, most patients were also on the steroid dexamethasone, which has itself shown a mortality benefit in COVID-19. With the combination of Actemra and dexamethasone, the risk of progressing to a ventilator was reduced.
The Gaza Strip will receive 1,000 doses of Russia’s Sputnik V vaccine after Israel approved the transfer. These are the first vaccines to reach Gaza, which has a population of two million. The Palestinian territory has reported 53,000 coronavirus cases, including 538 deaths.
UPDATED: Wednesday, Feb. 17 at 11:48 a.m. ET
FDA authorization of the Johnson & Johnson vaccine would be a critical step in the United States’ battle against the pandemic, and it could be a step nearer as a key FDA panel is set to meet next week. Ahead of the meeting, FDA scientists are reviewing data from clinical trials and plan to present their findings to the committee. The review process for this vaccine has taken longer than those for Moderna and Pfizer, largely due to the complexity introduced by the COVID-19 variants.
Pfizer’s new 200 million-dose agreement with the EU will be delivered in 2021, with 75 million promised in the second quarter. The agreement is in addition to the 300 million doses Pfizer pledged to provide to the EU last year, all to be supplied in 2021. With the agreements, Pfizer expects to “deliver enough doses to vaccinate at least 250 million Europeans before the end of the year,” Pfizer CEO Albert Bourla said.
Moderna also inked a new supply deal with Europe, pledging an additional 150 million vaccine doses. In total, Europe has purchased 310 million doses of the company’s vaccine for delivery in 2021.
So far, the EU has been hindered in the fight against COVID-19 as it has experienced vaccine delivery delays from key vaccine players. By the middle of last week, Pfizer had delivered 23 million doses, 10 million short of what had been promised.
The South Africa variant of COVID-19 has appeared in 32 countries so far, many of which have yet to approve the Johnson & Johnson vaccine. South Africa was set to begin vaccinating healthcare workers this week with doses from AstraZeneca, but officials put the plan on hold after reviewing evidence that the AZ vaccine has limited effectiveness against the 501Y.V2 variant.
In Taiwan, health minister Chen Shih-chung said that his country and Pfizer–BioNTech were set to make a deal in December when the drugmaker backed out. He claimed that BioNTech’s partner in China, Shanghai Pharmaceutical, had opposed the deal. Taiwan has managed the pandemic effectively, reporting only 938 cases and nine deaths.
The South Korean National Intelligence Service is disputing a claim by South Korean lawmaker Ha Tae-keung, who told Fintech Zoom that North Korea had hacked Pfizer in an attempt to steal information on COVID-19 vaccines and treatments. The NIS said it “reported general incidences of hacking attempts,” but did not specify company names, including Pfizer. Ha responded that in an NIS briefing to lawmakers, Pfizer was named.
UPDATED: Tuesday, Feb. 16 at 3:30 p.m. ET
Britain is working with the Serum Institute of India to audit manufacturing processes, which could clear the way for it to supply the UK. and EU with AstraZeneca’s COVID-19 vaccine. Serum Institute currently manufactures the vaccine for many of the world’s poorer countries while the UK. and EU mainly receive supplies from British and European facilities. The news comes after AZ last week said it could ease European supply shortfalls by sourcing doses from non-European facilities. Story
AstraZeneca’s success in developing vaccines and drugs to battle COVID-19 has reaped dividends for company CEO Pascal Soriot, who has earned $21.52 million in 2020, according to the company’s annual report. AZ’s board cited Soriot for delivering on financial and scientific goals—and his “inspiring leadership”—amid the pandemic Story
Thomas Triomphe, EVP of Sanofi Pasteur, told Bloomberg the company was set to start early trials in the coming weeks and could roll out its mRNA-based vaccine before the end of 2021.
Amgen’s Corlanor, on the market for six years to treat heart failure, may find a new market as a treatment for COVID-19 “long-haulers,” according to researchers at the University of California, San Diego. In a trial of 22 patients with postural orthostatic tachycardia syndrome, who have similar symptoms to many recovering from COVID-19, those treated saw their standing heart rate drop from between 100-115 beats per minute to 77, compared with those taking placebo. Story
Fast-rising biotech Adagio Therapeutics has dosed its first subject in a phase 1 clinical trial of its monoclonal antibody candidate for COVID-19, ADG20. Once the safety of the drug has been determined, Adagio will assess whether ADG20 can treat and prevent COVID-19. Adagio has evidence that its candidate is effective against emerging variants, despite earlier reports of their resistance to antibody treatments. Story
Emerging variants of COVID-19 are hindering clinical trials, according to GlobalData. “Increased restrictive measures” have interfered with work to resume trials halted because of the pandemic. Those measures include strict lockdown requirements and social distancing procedures. Story
South Korea said it has found evidence of attempts by North Korea to steal coronavirus data from U.S. drugmaker Pfizer. Vaccine and treatment technology were the targets of cyberattacks by North Korea, South Korean intelligence officials said. South Korea and Pfizer are trying to determine whether the hacks were successful.
UPDATED: Tuesday, Feb. 16 at 12:12 p.m. ET
After halting its vaccine rollout, South Africa may sell its stockpile of AstraZeneca doses, said the county’s health minister.
AstraZeneca’s vaccine is the second to be approved by Australia. The country signed off on the Pfizer vaccine last month and received its first shipment of doses on Monday. Health minister Greg Hunt said he expects 1 million doses to be available each week by the end of March.
Japan will begin vaccinations next week as it prepares to host the 2021 Olympic Games, July 24-Aug. 7. The government hopes to have its entire population (126 million) vaccinated by the middle of the year.
Korea has contracted COVID-19 vaccine doses from Novovax and Pfizer that would inoculate 23 million. Combined with previous deals with the same two companies, Korea will be able to immunize 79 million. Korea will kick off vaccinations on Feb. 26, starting with those working and hospitalized in nursing homes.
The Pfizer vaccine has been highly effective in Israel, according to Clait, a health maintenance organization which covers more than half of the county. Among 600,000 who have been vaccinated, there has been a 94 percent drop in infections. The vaccinations have proven most effective for those a week after receiving their second shot.
Iceland’s success in its fight against the COVID-19 pandemic has cost the country a chance to serve as a case study by Pfizer on the ability of vaccines to create herd immunity. In hopes of inoculating 70 percent of its population by the end of March, Iceland wanted to secure 500,000 doses from Pfizer. But despite inoculating only 4 percent of the population, cases in Iceland have dropped, limiting the potential effectiveness of the study.
Speaking on “Face the Nation” on Sunday, Scott Gottlieb, the former commissioner of the Food and Drug Administration, urged the Biden administration to take “bespoke” efforts to vaccinate Americans in underserved communities. Gottlieb said that the emergence of new coronavirus variants, first identified overseas and now evident in five states, makes it imperative for Americans to be vaccinated as soon as possible, requiring more creative efforts from the government.
UPDATED: Friday, Feb. 12 at 2:50 p.m. ET
BD scored U.S. and European nods for a new COVID-19 test that also screens for influenza A and B—plus, it should detect coronavirus variants first discovered in South Africa and the UK., BD said. Running on the company’s BD MAX platform, the molecular lab test is designed to deliver results in two to three hours and process hundreds of samples per day. Concerning mutations, BD ran computer analyses showing 99.9% of the genetic sequences of the South African and UK. variants would still match up to the molecular targets used in its tests. Story
Mallinckrodt will have to wait for an FDA decision on its regenerative skin therapy treatment StrataGraft, thanks to COVID-19 travel restrictions that forced the delay of a manufacturing plant inspection, the company said Friday. The FDA was originally due to make a decision on StrataGraft, developed to treat deep second-degree burns, on February 2. Pandemic-delayed inspections led the FDA to push back decisions on a slew of drugs last year, with Bristol Myers Squibb’s CAR-T therapy liso-cel a prominent example. Story
North Carolina’s state health department on Thursday reported its first case of an emerging virus variant originally discovered in South Africa. The sample of the so-called B.1.351 variant came from an adult who hadn’t recently traveled and was detected by Labcorp during routine genomic sequencing. The variant has also cropped up in Maryland, South Carolina and Virginia. As of Thursday, the CDC had reported 13 B.1.351 cases in the states.
By April, it should be “open season” for vaccinations in the U.S., NIAID director Anthony Fauci told NBC. “Namely, virtually everybody and anybody in any category can start to get vaccinated,” he continued. Fauci said he was hopeful that the majority of Americans would be vaccinated by the end of summer.
“By the time we get to April, that will be what I would call open season,” Dr. Anthony Fauci says about the timeline for vaccination availability for all groups to begin getting shots. pic.twitter.com/BMGD3YSVex
— TODAY (@TODAYshow) February 11, 2021
Hungary is now administering the Gamaleya Institute’s Sputnik V vaccine, an official at Honved Hospital in Budapest told The New York Times. In bypassing the European Medicines Agency, Hungary has become the first European Union member state to use Russia’s shot. The country has some 2,800 doses left over from a 6,000-dose shipment delivered in December for testing, and it has said it expects to receive 2 million doses from Russia over the next three months. The decision has drawn fire from local health experts, who’ve urged Hungarian regulators to wait on EU approval.
India aims to vaccinate 300 million people by August—but over a four-week stretch, it was only able to get 7.5 million COVID vaccines into frontline workers’ arms, Reuters reports. At that rate, it would take the country years to hit its immunization target. Supply isn’t the issue, one local health expert said, but to meet the government’s timeline, India will need to start vaccinating between four and five times more people each day. The government itself plans to pick up the pace next month, with the goal to enlist more private hospitals once priority groups get the shot.
UPDATED: Friday, Feb. 12 at 9:40 a.m. ET
The U.S. locked up a previously announced deal to buy another 100 million vaccine doses from both Pfizer and Moderna, lifting the country’s total order from those drugmakers to 600 million doses. The companies will roll out shipments in regular intervals through the end of July, the Department of Health and Human Services said. The government is shelling out some $2 billion to Pfizer for the extra doses, while Moderna will receive roughly $1.65 billion. So far, the government has pledged $6 billion to Pfizer for shot supplies, while Moderna is due a total of $5.75 billion in sale proceeds and R&D investment.
Moderna says it has so far delivered 41 million vaccines to the U.S., and more than 22 million Americans have received at least one dose of its shot. The company said it’s confident it can supply a total of 100 million doses by the end of the first quarter and 100 million more in Q2. It’s working with manufacturing partners stateside to speed up deliveries and ship this latest order before the end of July.
The European Medicines Agency kicked off a rolling review of CureVac’s mRNA vaccine. The regulator will assess data on CureVac’s shot as it comes in, building the case for a potential marketing authorization. The company’s shot, CVnCoV, is currently plowing ahead in a phase 2b/3 trial in healthy adults in Europe and Latin America, CureVac said.
The U.S. government’s promised vaccine safety monitoring system, dubbed BEST, is still in the development stages and won’t be able to analyze safety data for weeks or months, various health officials told The New York Times. FDA officials told the Times that they hope to start analyzing vaccine safety data soon, though that likely won’t occur until after President Joe Biden has hit his goal of vaccinating 100 million Americans. Tracking vaccine safety is especially important given the record development time for Pfizer and Moderna‘s shots.
A government health panel in Japan OK’d Pfizer and BioNTech‘s vaccine Friday, with the country’s health minister expected to issue a formal approval Sunday, Reuters reports, citing Japanese broadcaster NHK. Around 400,000 Pfizer doses arrived from Brussels on Friday as Japan gears up to start vaccinating healthcare workers by the middle of next week.
The UK.’s National Health Service will roll out Roche’s rheumatoid arthritis med Actemra, also known as tocilizumab, to “thousands more” COVID-19 patients after a positive data readout from the RECOVERY trial. In the study, Actemra cut the absolute risk of death by 4% versus standard care. In combination with the steroid dexamethasone, the drug reduced relative death risk by 14% and cut hospitalization time for patients on oxygen support by five days.
Patients given blood thinners within 24 hours of being hospitalized with COVID-19 are roughly 30% less likely to die than those who don’t receive them, an observational study in The BMJ showed. Researchers followed more than 4,000 patients over 30 days; 84% of them had received an anticoagulant within one day of hospitalization. At the end of the study, 14.3% of those on blood thinners died, compared with 18.7% of patients in the non-anticoagulant group, marking an absolute risk decrease of 4.4%, or a relative risk reduction of 27%.
Pfizer and Moderna are testing their vaccines in children ages 12 and up and expect to have results by the summer. Based on those studies, the companies could then move to test their shots in even younger children, The New York Times reports. “Moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule,” a Pfizer spokeswoman told the newspaper. Moderna started testing its shot in kids ages 12 to 17 in December and aims to recruit 3,000 subjects for its study.
After German newspaper Handelsblatt last month reported AstraZeneca‘s vaccine was just 8% effective in people older than 65, experts and AZ itself quickly contested the figure. But the paper stood firm, citing an unnamed health ministry official, The BMJ reports. “Confusion is out of the question,” a follow-up Handelsblatt story states. “According to the data available to us so far, effectiveness in people over 60 is less than 10%.” The paper “turned the matter into a ‘he says, she says’ story” to absolve itself, Markus Lehmkuhl, a professor at the Karlsruhe Institute of Technology, told BMJ.
UPDATED: Thursday, Feb. 11 at 3:07 p.m. ET
Novavax‘s vaccine program has already started rolling reviews in Europe, the U.S. and elsewhere, and now the company is close to a supply deal with Europe, Reuters reports. Preliminary talks completed in December and officials “aim to agree the contract this week or next,” one source told the news service. The deal would be for an initial 100 million doses with an option for 100 million more.
Visby Medical scored an FDA emergency nod for its rapid, single-use PCR test designed to detect COVID-19 infections at the point of care. A palm-sized device that plugs into a power outlet can conduct the test, which takes about 30 minutes. Story
With COVID-19 vaccines already authorized, it’s becoming tougher for vaccine developers to enroll trial participants in placebo-controlled studies. Second-wave vaccine companies are responding by looking at studies that weigh immune responses, rather than protection versus placebo, the Wall Street Journal reports.
While vaccine supplies are limited now, former FDA commissioners Scott Gottlieb and Mark McClellan predict a scenario not too far away when supply will exceed demand. They penned a Wall Street Journal op-ed about how to boost demand so that doses don’t go unused.
UPDATED: Thursday, Feb. 11 at 11:40 a.m. ET
Roche’s rheumatoid arthritis drug Actemra, also known as tocilizumab, cut the risk of death by 4% over standard care—including dexamethasone—in patients hospitalized with severe COVID-19, new data from the University of Oxford’s RECOVERY trial show. The drug also helped patients leave the hospital faster and reduced the need for mechanical ventilation. In patients with severe inflammation, Actemra plus the steroid dexamethasone cut mortality by about 33% for patients needing simple oxygen and nearly 50% for those on invasive mechanical ventilation, the researchers said.
AstraZeneca‘s asthma med Pulmicort, or inhaled budesonide, cut the risk of urgent care or hospitalization by 90% over a 28-day stretch, a study run by the University of Oxford and posted on the pre-print server MedRxiv showed. Researchers looked at 148 patients, half of whom received 800 micrograms of Pulmicort twice a day. Alongside reduced risk of hospitalization, the drug also led to “quicker resolution of fever, symptoms, and fewer persistent symptoms” after 28 days.
Speciality chemicals company Evonik is investing in the short-term expansion of its speciality lipids production to help boost supplies of Pfizer and BioNTech‘s mRNA vaccine. Commercial lipid production is set to kick off at the company’s Hanau and Dossenheim, Germany, sites as early as the second half of 2021, Evonik said.
Merck & Co. is “actively involved” in talks with governments, health agencies and other drugmakers to chip in on the pandemic response, including manufacturing authorized COVID-19 vaccines, a spokesperson told Fierce Pharma. Merck hasn’t said which companies it could support, but there’ve been rumblings it may tie up with Novavax. Evercore ISI analyst Josh Schimmer said as much after Novavax presented phase 3 data last month, while Novavax CEO Stan Erck told CNBC that Merck “could be a good partner for us as they don’t have a competing product.” Story
Novartis Oncology’s new campaign “Let’s Talk about the C Word: From Cancer to Cures,” aims to remind people that cancer hasn’t vanished amid the COVID-19 pandemic. “Especially during the pandemic, cancer got completely forgotten, and what for me was very concerning is that screenings were disrupted and diagnostics are now very late,” Susanne Schaffert, Ph.D., president of the company’s oncology unit, told Fierce Pharma. The monthly series of six short videos launched on World Cancer Day and focuses on prevention, diagnosis and disease management. Story
UPDATED: Wednesday, Feb. 10 at 3:11 p.m. ET
AstraZeneca‘s shot can be used to vaccinate all adults ages 18 and up, a World Health Organization panel recommended Wednesday. Efficacy isn’t expected to differ between young and old recipients, Alejandro Cravioto, chairman of the WHO’s Strategic Advisory Group of Experts on Immunization, said. The recommendation comes as some European countries like Norway and Portugal have sought to limit the shot’s use in people over the age of 65.
AstraZeneca and its German manufacturing partner IDT Biologika aim to hasten output of finished vaccines in Europe by the second quarter. Looking ahead, both companies plan to invest in a capacity upgrade at IDT Biologika’s site in Dessau, Germany, building up to five 2,000-liter bioreactors that can churn out “tens of millions” of COVID shot doses per month. The new bioreactors are expected to come online by the end of 2022. The move could support production of shots with similar manufacturing processes, paving the way for “Europe’s future vaccine supply independence,” AZ said.
Several people who received Pfizer or Moderna‘s vaccine soon after developed the rare blood disorder immune thrombocytopenia, though it’s unclear whether the shots themselves were responsible, The New York Times reports. FDA and CDC officials are investigating and say the cases could be coincidental. Pfizer told The Times it so far hadn’t established a link to its vaccine, while Moderna told the news outlet it “continuously monitors the safety” of its shot. Hematologists said the shot may have played a part, but noted cases after vaccination were likely to be very rare.
South Korea approved AstraZeneca‘s vaccine for emergency use in all adults ages 18 and older, with the caveat that AZ still needs to provide late-stage clinical data, The Korea Herald reports. While the country OK’d the shot in older adults, its Ministry of Food and Drug Safety recommends doctors use caution before deciding to give the vaccine to people over the age of 65. Korea is in line to receive 1.5 million AZ doses on February 24.
Thailand’s drug regulator is expected to sign off on Sinovac’s shot around the same time the country receives its first 200,000-dose shipment later this month, Bloomberg reports. It will use the Chinese-made vaccine to launch its immunization effort, though the majority of Thailand’s vaccines will come from AstraZeneca via local drugmaker Siam Bioscience. Thailand was banking on a 50,000-dose delivery of AstraZeneca shots to start its vaccination program on February 14, but the drugmaker’s tiff with Europe has delayed shipments to the country, Bloomberg said.
The European Union made some missteps in its handling of the pandemic, Ursula von der Leyen, president of the European Commission, told lawmakers. “We were late to authorize,” she said, adding that the bloc was “too optimistic when it came to massive production, and perhaps too confident that what we ordered would actually be delivered on time”—bringing to mind the EU’s public supply beef with AstraZeneca. Still, it’s better that the EU moved as a bloc and didn’t leave member states to fend for supplies themselves, von der Leyen said.
Texas is teaming up with the feds to build out three mass vaccination sites, Reuters reports. Each site will aim to deliver about 10,000 doses a day and should start getting shots into patients’ arms by February 22, Jeffrey Zients, the White House’s COVID-19 response coordinator, said. The sites will pop in the Dallas and Houston areas, with one pegged for the Dallas Cowboys’ AT&T Stadium in Arlington. The Federal Emergency Management Agency (FEMA) will run the sites.
UPDATED: Wednesday, Feb. 10 at 9:30 a.m. ET
People may be getting COVID-19 vaccines every year for the next several years, Johnson & Johnson CEO Alex Gorsky told CNBC’s Meg Tirrell. He pointed to the rise of virus variants, warning that every time the virus mutates, “it’s almost like another click of the dial so to speak where we can see another variant, another mutation that can have an impact on its ability to fend off antibodies or to have a different kind of response not only to a therapeutic but also to a vaccine.”
Eli Lilly’s antibody cocktail of bamlanivimab and etesevimab won an FDA emergency nod to treat mild to moderate COVID patients ages 12 and up who are at high risk of advancing to severe disease or hospitalization. The therapy, delivered as a single intravenous infusion, should be given “as soon as possible” after a person tests positive and within 10 days of symptoms starting, Lilly said. The FDA also signed off on infusion times for bamlanivimab alone and in combination with etesevimab as short as 16 or 21 minutes, respectively. Story
BioNTech has kicked off mRNA production at its facility in Marburg, Germany, and estimates a single mRNA batch at current scale is good for some 8 million doses. To ship out those supplies, the production processes at Marburg must first be cleared by the European Medicines Agency, with an assessment pegged for February and March, BioNTech said. Once fully operational, the site will boast capacity for 750 million doses a year. BioNTech aims to crank out 250 million doses at Marburg in the first half of 2021 and plans to deliver the first doses from the site in April. Story
India-based drugmaker Wockhardt bagged a six-month extension of its agreement with the UK. to fill and finish AstraZeneca‘s vaccine, the Daily Post reports. Wockhardt subsidiary CP Pharmaceuticals will continue to carry out the work at its plant in Wrexham, Wales, which is also getting 40 new hires.
South Africa next week will start vaccinating frontline healthcare workers with Johnson & Johnson’s unapproved shot, health minister Zweli Mkhize said. The country will use the rollout to study the shot’s efficacy, particularly against a virus variant that’s become dominant in the country. South Africa is now bypassing AstraZeneca‘s shot altogether because it “does not prevent mild to moderate disease” caused by the variant, Mkhize said. “The Johnson & Johnson vaccine has been proven effective against the 501Y.V2 variant,” he said, adding that South African approval processes were underway.
Japan has locked down 144 million Pfizer vaccine doses—enough for 72 million people—but thanks to shortages of low dead space syringes needed to extract a sixth dose from vials, some 24 million shots will go to waste, the Independent reports. If healthcare workers can’t muster that sixth dose, the extra product will need to be tossed, government spokesman Katsunobu Kato said. “We will use all the syringes we have that can draw six doses, but it will, of course, not be enough as more shots are administered,” Norihisa Tamura, Japan’s health minister, said.
A Trump appointee put pressure on the FDA to green light hydroxychloroquine and convalescent plasma in COVID-19, according to nearly 100 pages of emails released by the House Select Subcommittee on the Coronavirus Crisis. Paul Alexander, who last year served as a senior advisor to then-HHS assistant secretary for public affairs Michael Caputo, reached out directly to FDA chief Stephen Hahn and former deputy commissioner for medical and scientific affairs Anand Shah to push the treatments—in at least one case after HCQ’s emergency nod had been rescinded.
Drugmakers need to set aside old rivalries to keep COVID-19 vaccine supplies afloat, Carlo de Notaristefani, a former Teva exec and a lead manufacturing and supply chain adviser to Operation Warp Speed, said. If a company’s vaccine program is delayed or terminated, manufacturing resources should immediately be divvied up among those still in the race, he said. To make the move more enticing for highly competitive pharma companies, the government should act as a matchmaker, providing collaboration incentives and adapting existing rules, he added.
UPDATED: Tuesday, Feb. 9 at 3:13 p.m. ET
mRNA vaccines are likely the “go-to” for a single-antigen pandemic where speed is key, but in other disease areas with established prophylactics, mRNA candidates will face competition from “standard of care” vaccines that boast a “well-characterized safety profile,” Sanofi CEO Paul Hudson told Barron’s. The COVID-19 pandemic helped put mRNA on the map, but that doesn’t mean developers should “walk away” from established tech just yet, vaccine experts agreed on a recent Fierce Pharma panel. Story
Verily is joining forces with Johnson & Johnson’s Janssen unit to identify early warning biomarkers for COVID-19 that could guide future treatments and potentially predict whether a person’s case may turn severe. Verily will use its Project Baseline testing program, collecting biological information and real-world data in the weeks right after a person tests positive, with subjects able to participate from their homes. The parties will also tap data from patients’ everyday lives to ID any health-related signals in the two years before and after they consent to the study. Story
Baltimore Mayor Brandon Scott wants Johnson & Johnson to sell 300,000 vaccine doses straight to the city to help distribute supplies equally. In a letter to J&J, Scott said that if the sale goes through—pending federal approval and interest from J&J—he would set up a subcommittee of the city’s Vaccine Distribution Task Force that includes company representatives, Baltimore health department officials and community leaders. Maryland governor Larry Hogan was less optimistic: “I mean, everybody would like a jump to the front of the line, but it’s not going to happen,” he said.
As Mayor, my highest priority is keeping Baltimoreans healthy and safe.
Today, I sent a proposal to JNJGlobalHealth?ref_src=twsrc%5Etfw”>@JNJGlobalHealth requesting partnership to directly purchase 300,000 vaccines manufactured here in Baltimore and ensure equitable vaccine distribution. Full letter below. pic.twitter.com/X68jR80y8F
— Brandon M. Scott (@MayorBMScott) February 8, 2021
Miami-based Veru reports that its cancer asset, VERU-111, charted a “statistically significant and clinically meaningful reduction” in the proportion of COVID patients who were treatment failures—meaning dead or alive with respiratory failure—in a 40-subject phase 2 trial. The company tested its drug in hospitalized patients at high risk of acute respiratory distress syndrome from the virus. At the 29-day mark, the VERU-111 group, which included 18 patients, had a treatment failure rate of 5.6%, versus the 20-patient placebo arm’s 30%. Story
Tiziana Life Sciences’ intranasal antibody hopeful foralumab helped patients in a small phase 2 study. The trial randomized 39 patients to receive foralumab, foralumab plus dexamethasone or no treatment. The foralumab group displayed 80% improvement in the lungs, compared to 75% in the combo cohort and 43% in the control group, CT scans showed. Antibodies usually aren’t a good fit for nasal delivery, but Tiziana pegged foralumab as an exception after assessing its ability to act on systemic immunity via the epithelial lining of the nose. Story
New oncology trials plummeted 60% globally during the first wave of the COVID-19 pandemic, which ran from January to May 2020, data out from Medidata and published by the JAMA network found. The pandemic “may be associated with longer term indirect effects on population morbidity and mortality through pathways such as halted drug development,” according to the JAMA findings. Story
UPDATED: Tuesday, Feb. 9 at 11:25 a.m. ET
Merck KGaA expanded its pact with German compatriot BioNTech to rapidly boost lipid supplies for the company’s mRNA shot by the end of the year. To build out its already impressive lipid production capacity, Merck KGaA says it’s spent the past several weeks tweaking production technologies and implementing new, complex process steps. Lipids are combined with mRNA to create lipid nanoparticles, central to the delivery of Pfizer and BioNTech‘s shot.
The viral vector vaccine developed by China’s CanSino Biologics was 65.7% effective at preventing symptomatic disease in phase 3. Against severe disease, the shot was 90.98% effective, Pakistan’s health adviser, Faisal Sultan, said on Twitter. CanSino later forwarded Sultan’s comments in a statement. Like Johnson & Johnson’s shot, CanSino’s vaccine works at one dose and is easier to store than the mRNA vaccines from Pfizer and Moderna. CanSino’s phase 3 included 30,000 subjects across Pakistan, Russia, Argentina, Mexico and Chile.
Johnson & Johnson is looking to manufacture its COVID-19 vaccine in India, Reuters reports, citing a local government official. The country currently feels confident about the efficacy of AstraZeneca‘s vaccine, which is being produced by Serum Institute of India for some countries under the name Covishield, the official added.
South Africa could still deploy AstraZeneca‘s vaccine in a “stepped manner,” rolling out 100,000 doses and monitoring their effect on hospitalizations and deaths, the Sunday Times reports. Multiple countries and health organizations defended AZ’s shot after a new study showed it was less effective against a virus variant discovered in South Africa. “Obviously the world is full of the wild type virus that this AstraZeneca vaccine is known to work against,” Richard Hatchett, CEO of CEPI, said. Other health experts cited limitations in the size and duration of the study.
India, for its part, hasn’t discovered any local cases of the South African variant and will continue to use AstraZeneca‘s shot in its vaccination drive, Reuters reports. The country will “intensify” its surveillance and watch other developments on the shot “in due course,” according to top Indian vaccine official Vinod Kumar Paul.
Israel’s MyHeritage lab, which handles more than 10,000 COVID-19 tests a day, unveiled partial evidence that Pfizer and BioNTech‘s vaccine stops the virus’ spread. The lab said positive test results among patients ages 60 and older had up to 60% smaller viral loads than those from patients between the ages of 40 and 59. The shift started in mid-January, when most of the country’s older population had received its first dose. The results are limited because MyHeritage didn’t know if individual samples came from patients who’d received the shot.
The coronavirus likely jumped to humans from an animal, Peter Ben Embarek, food safety and animal diseases expert at the World Health Organization, said Tuesday. Embarek’s remarks came after his WHO team wrapped its investigation on the coronavirus’ potential origins in the city of Wuhan. The exact animal host hasn’t been identified, and Embarek partially discounted the possibility of a direct jump from bats, suggesting more work needs to be done to trace potential transmission.
UPDATED: Monday, Feb. 8 at 3:10 p.m. ET
AstraZeneca and the University of Oxford will tweak their vaccine to target virus variants with mutations similar to the South African version, dubbed B.1.351. “Efforts are underway to develop a new generation of vaccines that will allow protection to be redirected to emerging variants as booster jabs, if it turns out that it is necessary to do so,” Oxford’s Sarah Gilbert, Ph.D., said in a statement. The new shot could be ready by fall, she added. The move comes after a new study cast doubt on the shot’s efficacy against mild and moderate disease caused by the B.1.351 variant. Story
Those study results led South Africa to halt its rollout of AstraZeneca‘s vaccine, prompting several other countries to defend the shot, Reuters reports. AZ’s vaccine offers adequate protection against “nearly all the variants” of the virus, French Health Minister Olivier Veran said, and all three shots cleared in Europe, including AZ’s, defend against serious infections, Jens Spahn, Germany’s Health Minister, said. There’s currently no evidence to suggest AZ’s shot has become less effective at preventing severe disease and death, Gregg Hunt, Australia’s Health Minister, added.
Covaxx’s multitope protein/synthetic peptide-based vaccine candidate, UB-612, yielded neutralizing antibodies in 100% of patients after two doses, early phase 1 data showed. Researchers looked at three doses—10, 30 and 100 micrograms—in 60 healthy adults between the ages of 20 and 55. At the the 100-microgram dose, anti-spike-protein receptor-binding domain and virus-neutralizing antibody responses “compared favorably” to those from hospitalized patients who’d recovered from COVID. The majority of side effects were short and mild, and none were serious, Covaxx added.
Eighty percent of Americans appear willing to get a COVID-19 shot, a new W20 Group study using search and social data found. Among politically right-leaning respondents—defined as those who follow at least three right-leaning politicians, journalists or news outlets—only 41% show a willingness to get the vaccine, versus 95% of the center left, 93% of the educated left and 91% of apolitical groups ready to get the shot. Sixty percent of those right-leaning respondents unwilling to get the vaccine cited freedom of choice in the matter as their main sticking point. Story
The Trump Administration meddled with testing guidance last summer “in order to hide evidence the virus was spreading rapidly among asymptomatic people,” James Clyburn, chairman of the House of Representatives’ Select Committee on the Coronavirus Crisis, alleges in letters to White House chief of staff Ron Klain and HHS acting secretary Norris Cochran. Clyburn’s claim relates to the CDC’s August guidance that people who’d been exposed to the virus and weren’t symptomatic didn’t need to get tested. The CDC has since acknowledged the potential for asymptomatic spread on its website.
A coronavirus variant that first cropped up in the UK., dubbed B.1.1.7, could become dominant in the U.S. by March, a new study published on the pre-print server medRxiv found. The variant is spreading fast in the states, doubling roughly every 10 days, the researchers said. The team estimates that the transmission rate of the British variant is about 30% to 40% higher than more common variants, too—and that number could rise as more data come in, one of the study’s co-authors told The New York Times.
UPDATED: Monday, Feb. 8 at 9:45 a.m. ET
Novavax‘s protein-based vaccine prospect has started rolling reviews in Europe, the UK., the U.S. and Canada. The company has started submitting early data on the program to regulators, and the reviews are designed to speed up the process for potential emergency authorizations. The vaccine is in phase 3 testing in the UK. and U.S., and a separate trial of the candidate previously showed high efficacy.
Pfizer aims to cut the time to produce a COVID-19 vaccine batch from 110 days to about 60 days, Chaz Calitri, VP for operations and sterile injectables, told USA Today. DNA production—the first step in Pfizer‘s vaccine manufacturing process—is one process in line for a speed boost, Calitri said. Making that DNA originally took 16 days, but it will soon take just nine or 10. Meanwhile, the company is adding production lines at its plants in Michigan, Missouri and Massachusetts.
AstraZeneca and the University of Oxford’s vaccine looks ineffective against mild or moderate disease caused by a virus variant first ID’d in South Africa, a non-peer-reviewed study showed. Looking at both the blood of vaccinated individuals and more than 2,000 healthy subjects, South African and Oxford University researchers found that while none of the subjects died or were hospitalized, a two-dose vaccine regimen failed to confer protection. Efficacy against severe disease, hospitalizations and deaths has yet to be determined.
With those data in hand, South Africa is halting its AstraZeneca vaccine rollout, Reuters reports. “This study confirms that the pandemic coronavirus will find ways to continue to spread in vaccinated populations, as expected,” Andrew Pollard, chief investigator of the Oxford vaccine trial, told the news outlet. “But, taken with the promising results from other studies in South Africa using a similar viral vector, vaccines may continue to ease the toll on health care systems by preventing severe disease,” he said.
Portugal’s health ministry recommends AstraZeneca‘s vaccine be used in people below the age of 65. Still, older people shouldn’t delay their vaccinations if AZ’s shot is the only one available, the ministry said. The country on Sunday received its first batch of 42,300 AstraZeneca doses. Portugal isn’t the first country to question the shot’s efficacy in older patients. Norway on Thursday said it wouldn’t give the vaccine to people over the age of 65, citing a lack of older participants in AZ’s trials.
Sinovac’s shot CoronaVac won a conditional marketing authorization from China’s drug regulator. Sinovac kicked off a rolling submission in September, filing for conditional authorization on February 3. The China National Medical Products Administration issued its green light on the basis of two month’s data from phase 3 trials, Sinovac said. Final results aren’t yet available, and efficacy and safety will be “further confirmed” the company added. The shot is currently approved for emergency use in Chile, Turkey, Indonesia and Brazil.
Orders for Zydus Cadila’s homegrown COVID-19 vaccine have outstripped capacity, Moneycontrol reports. “In terms of our opportunity size, we have orders far more than what we can make … I have to work on prioritization of supplies and manufacturing,” Sharvil Patel, managing director of Cadila Healthcare, told analysts. The company has been building out a facility to produce 120 million doses of its plasmid DNA candidate, which entered phase 3 last month. Meanwhile, Zydus says it’s hunting for manufacturing partners to ultimately hit a production target of about 200 million doses.
Hospital use of the steroid dexamethasone and Gilead Sciences’ antiviral Veklury, also known as remdesivir, has doubled since the summer, according to care coordination software company CarePort Health. Across the hospitals CarePort examined, Veklury use hit 17% the week of January 5, compared with 5% the week of July 7. Meanwhile, dexamethasone usage surged to 43% in January, versus 20% in July, a CarePort spokesperson said. Providers may be relying on those treatments as a stopgap until vaccinations are more widespread, CarePort figures.
UPDATED: Friday, Feb. 5 at 3:00 p.m. ET
German mRNA specialist CureVac is teaming up with the UK. Vaccines Taskforce to study coronavirus variants and develop vaccine candidates against selected mutations. The government will hustle along clinical trials in the UK. to secure emergency or conditional nods for the shots as quickly as possible. The pact covers an initial supply of 50 million variant vaccines, which will be manufactured in the UK. Should any of the vaccines pass muster with British regulators, they’ll be rolled out in the UK., as well as in its overseas and dependent territories. Story
Sales for Roche’s diagnostics division grew 14% over the full year of 2020, breaching 13.8 billion CHF, or about $15.3 billion. COVID-19 tests supplied a massive chunk of that revenue haul, helping to offset losses caused by pandemic lockdowns and delayed health screenings. The company’s molecular diagnostics segment carried the bulk of the growth, raking in some $4.16 billion—an increase of more than 90% over 2019 at constant exchange rates. Roche last year launched 15 COVID-19 tests, including rapid, point-of-care solutions and high-throughput, centralized lab diagnostics across all test types. Story
Regeneron’s antibody cocktail snared $146 million in fourth-quarter sales, falling short of analyst expectations and coming in well below the drugmaker’s own predictions. Still, the cocktail could perform better in 2021: Regeneron in January agreed to sell up to 1.25 million more doses to the U.S., building on its previous order for 300,000. If uptake improves, Regeneron could bank up to $2.625 billion on the new contract. The company still has $466 million worth of doses left to deliver from its initial deal, but it aims to roll out 750,000 doses from the second order by the end of June. Story
Gilead‘s antiviral Veklury, also known as remdesivir, ginned up $2.8 billion in 2020. The drug enjoyed a big boost in the fourth quarter, pulling $1.93 billion, as hospitalizations and treatments peaked on the back of a COVID-19 surge, the company said. Meanwhile, as vaccination efforts gain steam, Gilead estimates between $2 billion and $3 billion in Veklury sales for 2021. Beyond the company’s COVID superstar, overall sales fell 3% to $21.5 billion as generic competition for Truvada and Atripla took its toll. Story
Drugmakers ought to share their manufacturing capacity to help boost production of COVID-19 shots, WHO director general Tedros Adhanom Ghebreyesus said Friday. “We also need a massive scale-up in manufacturing,” he added.
Over time, SARS-CoV-2—the virus behind COVID-19—deletes part of the genetic code for the spike protein on its surface, which stops some antibodies from attaching to and neutralizing the virus, researchers at the University of Pittsburgh School of Medicine found. They’ve published their findings in the journal Science. The team found several genetic deletions, all of which changed the spike protein’s shape just enough so antibodies couldn’t recognize it. The virus variant first discovered in the UK. was among those found to have these deletions, they said. Story
The same “scalper bots” that buy Playstation 5s and designer sneakers to resell at astronomical prices are targeting COVID-19 vaccine appointments, prompting pharmacies like Walgreens and CVS to mount a defense, Reuters reports. Walgreens has set up security measures like bot prevention and detection, while CVS says its appointment site “has a layered defense that includes capabilities to detect automated cyber attacks, such as botnets.”
UPDATED: Friday, Feb. 5 at 10:45 a.m. ET
It’s official: Johnson & Johnson has filed for emergency FDA authorization of its one-and-done COVID-19 vaccine. The FDA has queued up an advisory committee to parse through the application on February 26. The move comes less than a week after the Big Pharma unveiled data showing its viral vector vaccine was 66% effective against moderate to severe disease. J&J plans to have doses ready to roll as soon as the FDA makes a decision, with the goal to sell 100 million shots in the U.S. by mid-year. Story
Pfizer and AstraZeneca‘s vaccines are “extremely safe,” says the UK.’s drug regulator. To reach that conclusion, the Medicines and Healthcare products Regulatory Agency looked at safety reports from nearly 7 million doses administered through January 24. MHRA received 22,820 reports of suspected reactions, but almost all cases were mild and largely involved reactions like arm soreness and flu-like symptoms. Those are typical responses to the vaccine, MHRA said, noting that severe allergic reactions to Pfizer‘s vaccine can happen, but are rare.
Pfizer pulled the emergency use application for its vaccine in India, Reuters reported. The pharma giant met with India’s drug regulator Wednesday, and “[b]ased on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” the company said. It plans to re-submit an approval request once more information becomes available. India’s drug regulator previously said it wouldn’t approve the shot without a small local trial in Indians, Reuters has reported.
The FDA will keep reviews for variant-focused booster shots swift, acting commissioner Janet Woodcock, M.D., said Thursday. If emerging variants necessitate boosters or changes to vaccines, the regulator won’t require the same large-scale trials needed to secure an emergency nod or approval, she said. The process will likely call for safety information, as well as a potential review from an external committee of experts. The FDA plans to issue a proposal on the process in the coming weeks, Woodcock said. Story
Pfizer is ahead of schedule in its quest to deliver an additional 100 million shot doses to the U.S., company representatives said Thursday before the Michigan House Health Policy Committee. That abbreviated timeline is the result of production boosts and a bonus sixth dose found in vials of Pfizer‘s vaccine, the representatives said. Those deliveries, originally pegged to arrive by the end of July, should now reach states by the end of May.
Moderna is in talks with South Korea to build out a $200-million vaccine manufacturing facility—potentially in Seoul, Park Young-sun, a former government minister involved in the talks, told the Asia Business Daily. It’s unclear when the plant could come online or how many doses it might produce. Story
South Korea on Friday authorized Celltrion’s COVID-19 antibody drug, Regkirona, though the company is still on the hook to supply phase 3 data, Korea Biomedical Review reports. The country’s Ministry of Food and Drug Safety cleared the drug in mild patients in high risk groups, as well as adult patients with moderate symptoms.
Daiichi Sankyo snared an outsourcing agreement with AstraZeneca to produce the drugmaker’s University of Oxford-partnered vaccine in Japan, Daiichi said Friday. Under the deal, the company’s Daiichi Sankyo Biotech unit will crank out doses through the fill-finish step at a facility tapped in the Japanese Ministry of Health, Labour and Welfare’s scheme “for developing and producing novel influenza virus vaccines.”
AstraZeneca, armed with results from a non-peer-reviewed study, recently suggested its shot could curb the coronavirus’ spread. Taking nasal swabs from vaccinated and unvaccinated people, AZ found positive tests were 50% lower among those who got two doses versus people who received no vaccine, making a case for the shot lowering transmission, it figures. Others aren’t convinced. “What they show is that there was [either] decreased viral shedding or decreased detection of virus”—not decreased spread, Carlos del Rio, associate dean of Emory School of Medicine, told Time.
The world’s approach to flu vaccines could provide a roadmap for the FDA’s booster reviews, Politico reports. Yearly flu shots are based on a foundational vaccine that’s altered to tackle the variants that emerge in a given season. Using this approach, drugmakers could skip lengthy trials enrolling thousands of subjects and instead prove safety and efficacy in smaller studies of a few hundred volunteers. “The flu model is the only thing that makes sense,” Paul Offit, M.D., told Politico, noting the challenge of running an efficacy trial now that many people have been vaccinated.
A slim 2.5% of the European Union’s population has received a first vaccine dose, putting the bloc well behind the U.S., the UK. and Israel. “We need to speed up vaccinations,” Hans Kluge, the World Health Organization’s European director, told news outlet AFP. Now, it’s up to drugmakers to take part in efforts to “drastically increase production capacity,” he said. He further recommended that wealthy nations share their shot supplies once they’ve vaccinated the elderly, healthcare workers and people with underlying conditions that put them at higher risk.
Norway won’t give AstraZeneca‘s vaccine to people over the age of 65, the Norwegian Institute of Public Health (FHI) said Thursday. FHI cited a lack of older participants in AstraZeneca‘s trials as cause for its decision. So far, about 135,000 Norwegians have received their first shot, with some 35,000 getting their second dose—all of those with Pfizer and Moderna‘s vaccines, FHI said.
Police in Florida are searching for a man who stole a gray Hyundai Accent loaded up with 30 vials of Pfizer and BioNTech‘s CVOID-19 vaccine. The keys were left in the ignition, and the car was boosted from a vaccination site at the Strawberry Festival Fairgrounds in Plant City, authorities said. The 30 vials contained between 150 and 180 doses.
UPDATED: Thursday, Feb. 4 at 2:55 p.m. ET
As Roche weathers biosimilar pressure on key medicines, the pandemic took a toll on sales of drugs such as multiple sclerosis med Ocrevus and wet age-related macular degeneration treatment Lucentis. Many patients stayed home and didn’t get treatments or didn’t switch to new offerings, the company said in its fourth-quarter results. Story
As Novavax negotiates more supply deals for its coronavirus vaccine candidate, the company this week unveiled an agreement in principle with the Swiss government for 6 million doses. Novavax’s vaccine was recently shown to be 89% effective in a late-stage study.
After officials in the Bolivian city of Trinidad last year started a campaign to give out free doses of Merck‘s anti-parasite drug ivermectin for COVID-19, the company says a data analysis doesn’t support using the medicine against COVID-19.
While doctors in places around the country are still having a hard time getting doses of the coronavirus vaccine, one doctor in the remote town of Cut Off, Louisiana, got a shipment this week, he told Fierce Healthcare. Story
UPDATED: Thursday, Feb. 4 at 11:45 a.m. ET
Amid worries about vaccine supply constraints, UK. researchers on Thursday kicked off a trial to assess a two-shot schedule combining Pfizer and AstraZeneca‘s shots. The study will look at the immune responses generated by an initial dose of Pfizer‘s shot, followed by AstraZeneca‘s—and vice-versa, at intervals of four and 12 weeks. Researchers plan to recruit some 800 participants and expect initial results by June. Story
AstraZeneca and the University of Oxford are working “as rapidly as possible” on next-generation COVID-19 vaccines to tackle emerging virus variants, Reuters reports, citing company research chief Mene Pangalos. “We’re working very hard, and we’re already talking about not just the variants that we have to make in laboratories, but also the clinical studies that we need to run,” he said during a media briefing. The company aims to have something ready by as early as autumn, he added.
Recruitment has picked up for Moderna‘s study assessing its mRNA vaccine in kids between the ages of 12 and 17, a company spokeswoman told the Boston Globe. The company aims to recruit 3,000 subjects and expects to deliver results by the middle of the year, she said. Pfizer last month finished recruitment for a trial of its own shot in children ages 12 to 15.
When the FDA cleared the use of a sixth dose in Pfizer‘s vaccine vials, demand spiked for special syringes needed to stretch supply. Thing is, the company had been working on a way to extract that bonus dose months before pharmacists had the idea themselves, The Washington Post reports. “I think this could have been anticipated. … It’s one more thing that was lost in the woodwork during the vaccine response,” former FDA staffer Jesse Goodman said. Meanwhile, Biden officials last week said they’d secured enough low-dead-space syringes to accompany all Pfizer shipments.
Pfizer won’t stop testing its shot against emerging variants anytime soon, the company’s vaccine chief, Philip Dormitzer, M.D., Ph.D., told ScienceInsider. Lab tests have so far shown South African and British variants could reduce efficacy, though the company doesn’t think it needs to alter its shot just yet, he said. The company is running tests on a variant first observed in Brazil, too, and expects to unveil South African and Brazilian data imminently. “At the rate that this virus is spinning out variants, we will be continuing to do this for quite some time,” Dormitzer added.
UPDATED: Wednesday, Feb. 3 at 3:30 p.m. ET
The European Medicines Agency’s human medicines committee (CHMP) kicked off a rolling review of Novavax’s shot, NVX-CoV2373, basing its decision on preclinical and early clinical data showing the vaccine triggers an antibody and immune cell response against the virus that causes COVID-19. The EMA will evaluate Novavax’s clinical data as it comes in until there’s enough evidence for a formal marketing authorization application.
Switzerland stopped short of approving AstraZeneca‘s vaccine as it awaits additional efficacy and quality data from North and South American trials, drug regulator Swissmedic said Wednesday. “As soon as the results have been received, a temporary authorization according to the rolling procedure could be issued at very short notice,” Swissmedic said. Meanwhile, the country bought 5 million CureVac doses, 6 million more Moderna doses and forged a preliminary pact for 6 million Novavax doses, for a total supply of more than 30 million shots.
Bristol Myers Squibb picked up the global rights to a pair of early-stage antibodies discovered by The Rockefeller University. The parties are keeping financial details close to the vest, with Rockefeller in line for sales royalties should the product hit the market. The university last month kicked off a 15-subject phase 1 study to assess subcutaneous and intravenous delivery of several doses of the two antibodies. If a low-dose subQ formulation is effective, which preclinical data suggest, BMS could be able to deliver large volumes of the product at a relatively low cost. Story
Biogen’s spinal muscular atrophy blockbuster Spinraza took a fourth-quarter sales hit courtesy of COVID-19. Sales of the drug slipped 34% compared to the same period last year, with the “majority” of that decline due to patients opting out of treatment center visits during the pandemic, CEO Michel Vounatsos said on an analyst call. He said COVID-19 was “accelerating switches to alternative treatment,” too, such as Roche’s oral competitor Evrysdi. Meanwhile, Novartis’ gene therapy rival Zolgensma has also turned up the heat on Biogen’s drug. Story
Meanwhile, GlaxoSmithKline’s shingles vaccine Shingrix posted 11% sales growth in 2020, signaling a slowdown for a product that more than doubled sales in 2019. Pandemic lockdowns had a hand in slashing vaccination numbers, and the company expects Shingrix disruptions to persist in the U.S. until at least the back half of 2021. While sales did tick up in the fourth quarter, governments prioritizing COVID-19 vaccinations will likely take a toll on “all adult vaccinations, including Shingrix,” Luke Miels, GSK’s president of pharmaceuticals, told investors Wednesday. Story
AstraZeneca‘s vaccine was 54.9% effective in trial subjects who got their second dose within six weeks of the first—and that figure jumped to 82.4% in patients who waited 12 or more weeks, new data published in Preprints with The Lancet showed. A standard dose was found to be 76% effective between 22 days and 90 days after the first injection, offering protection while people wait on a booster. The data support AZ chief Pascal Soriot’s recent recommendation that the European Union vaccinate as many people as possible now without holding back booster doses. Story
Serum Institute of India will provide 1.1 billion doses of AstraZeneca and Novavax’s vaccines to the World Health Organization’s equitable shot distribution scheme, Covax, UNICEF chief Henrietta Fore said Wednesday. Those deliveries will roll out over several years with individual doses priced at around $3 for low- and middle-income countries, she said.
BD is rolling out a new COVID-19 blood test in Europe designed to help hospitals flag patients who are more likely to require intensive care with a ventilator and are at higher risk of death. The test evaluates a person’s immune system by measuring the percentages and absolute counts of T, B and natural killer cells, plus subpopulations of T cells in peripheral blood. Researchers at BD have found that the risk for ventilation or death spikes if CD4 T-cell counts drop below 250 per microliter or if CD8 cells are under 100 per microliter. Story
UPDATED: Wednesday, Feb. 3 at 9:30 a.m. ET
GlaxoSmithKline is paying CureVac up to €150m ($180 million) to co-develop next-generation mRNA vaccines against COVID-19, with a focus on emerging virus variants. The partners will develop a number of candidates, which they figure could protect people who haven’t been vaccinated or serve as boosters if immunity wanes over time. Meanwhile, GSK has also tapped its Belgian manufacturing network to help produce up to 100 million doses of CureVac’s first-generation mRNA shot in 2021. Story
Evotec subsidiary Just-Evotec Biologics bagged a $28.6 million contract from the Department of Defense (DOD) to help produce COVID-19 antibody drugs. Just-Evotec will set aside present and future manufacturing capacity at its soon-to-be-completed J. POD facility in Redmond, Washington, for the next seven years. The DOD first tapped Just-Evotec in July 2020 to help pinpoint potential antibodies—a move that yielded “rapid process development and manufacture of high yielding mAbs against SARS-CoV-2,” the company said.
A recent Tweet got people wondering why more drugmakers haven’t stepped up to produce COVID-19 vaccines:
— James Hamblin (@jameshamblin) February 2, 2021
Thing is, that’s just wrong, medicinal chemist Derek Lowe wrote in his long-running “In the Pipeline” blog. There aren’t “dozens” of companies ready to produce Pfizer and Moderna‘s shots because making an mRNA vaccine is both a new and complex process, which requires special equipment that most companies simply do not have. He pointed to the step where lipids and mRNA are combined into lipid nanoparticles as a particularly challenging bottleneck. Pfizer and Moderna both seem to be doing this step in-house, likely using “special-purpose bespoke” microfluidics devices.
The FDA slapped New Jersey’s Eagle Pharmaceuticals with a complete response letter on its abbreviated new drug application for vasopressin, which the agency has flagged for its potential to treat COVID-19. Eagle has met twice with the FDA about the CRL and says it will hold an additional meeting within 30 days. The company will need to complete one additional short-duration study, which it plans to run in either mid-February or mid-March.
Mexico became the first North American country to authorize Russia’s Sputnik V vaccine, the Russian Direct Investment Fund said Wednesday. The vaccine has so far been cleared in 17 countries including Russia, Hungary, Argentina, Bolivia and Palestine.
Delaying the second dose of Moderna‘s shot appears fine, but doing the same for Pfizer‘s vaccine could cause deaths and infections to spike, a study posted on the pre-print server medRxiv found. Other experts aren’t convinced, National Post reports. The researchers’ underlying assumption that Pfizer‘s shot is just 52% effective after the first dose is faulty, Julie Bettinger, a member of Canada’s vaccine advisory board said. In fact, the first dose is closer to 90% effective after two weeks, Caroline Quach Thanh, M.D., chair of Canada’s National Advisory Council on Immunization, said.
Humanigen tapped CDMO Avid Bioservices to expand production capacity for its monoclonal antibody lenzilumab, designed to treat and prevent the immune hyper-response “cytokine storm.” Avid will start tech transfer and analytical validation services with a view to produce drug substance batches for potential commercial supply, the companies said. Humanigen has fully enrolled a phase 3 trial of the drug and says it could file for an emergency use authorization later this year.
UPDATED: Tuesday, Feb. 2 at 3:15 p.m. ET
Taking a cue from Pfizer, Moderna hopes to raise the number of doses in its vaccine vials from 10 to upward of 15, The New York Times reports. As Moderna ramps up shot production, the fill-finish stage has become something of a bottleneck, hindering efforts to boost distribution in the U.S. Moderna has discussed the move with the FDA, but has yet to submit manufacturing data to get the change approved, sources close to the talks told the Times.
CDMO Catalent saw its biologics revenue jump to $403.9 million in the second quarter of its fiscal year, marking a whopping 76% increase at constant currencies over the same period in 2019. That boost comes courtesy of the company’s myriad COVID-19 manufacturing contracts, which include vaccine pacts with AstraZeneca, Moderna and Johnson & Johnson, CEO John Chiminski said on an earnings call. The company is also looking to rapidly bring additional shot capacity online at facilities in the U.S. and Europe, he said. Story
Australia’s Ellume bagged a $231.8 million contract from the Biden Administration to set up its first U.S. production facility and deliver 8.5 million at-home tests. The FDA in December cleared Ellume’s test to be sold over-the-counter and used solo, regardless of whether a person has symptoms. The diagnostic is designed to go from swab to result in about 20 minutes. The planned U.S. facility is expected to produce more than 640,000 tests per day before year-end, building on Ellume’s current daily capacity of about 200,000 tests. Story
People who previously had COVID-19 may need just one vaccine dose to mount an effective antibody response, a study published on the pre-print server medRxiv found. Researchers reported that a single vaccine dose in patients with pre-existing immunity yielded antibody levels on par with—and sometimes exceeding—those seen in non-infected patients after their second dose. Changing the number of doses patients with pre-existing immunity receive could free up limited vaccine supplies, the authors suggest.
The U.S. Centers for Disease Control and Prevention is expanding efforts to track coronavirus variants, Director Rochelle Walensky, M.D., said. The agency now aims to sequence 7,000 coronavirus samples per week, up from just 251 during the week of January 10. As of last week, the CDC was working with commercial lab partners to overhaul its NS3 sequencing system to better catch virus variants, Walensky said. Its lab partners have pledged to analyze 6,000 samples per week by mid-February, she added.
It’s tough to tell the flu and COVID-19 apart—something Roche’s Genentech unit is stressing to patients in its new DTC campaign for influenza med Xofluza. A new TV spot takes an extra 15 seconds to say as much, and it encourages anyone experiencing flu-like symptoms to contact a healthcare provider. The pharma wanted to ensure viewers understand Xofluza doesn’t treat COVID-19, Laura Sullivan, the drug’s marketing director, said. Story
UPDATED: Tuesday, Feb. 2 at 11:21 a.m. ET
Pfizer expects to bag $15 billion in sales of its mRNA vaccine Comirnaty—and that number could be even higher, the company said Tuesday. In last year’s fourth quarter, the shot contributed $154 million. The company based its $15 billion estimate—part of its 2021 guidance—on doses set to be delivered in 2021 through established contracts, but the estimate could grow “if additional contracts are signed,” according to the company’s investor presentation. Story
Canada aims to produce Novavax’s vaccine at a new National Research Council plant in Montreal, CP24 reports. Prime Minister Justin Trudeau is expected to announce a deal with the company on Tuesday. The facility is designed to produce a slim 2 million doses per month and is still under construction, meaning production is still some two months out, CP24 said. Canada’s supply worries have intensified as the European Union imposes export controls on COVID shots following a supply kerfuffle with AstraZeneca. Canada’s Pfizer and Moderna doses are both made in Europe.
AstraZeneca‘s Chinese vaccine manufacturing partner, Shenzhen Kangtai, has completed a facility with capacity for 400 million AZ doses, the company said Tuesday. The expansion will allow Shenzhen Kangtai to double the capacity target it agreed to last year. AstraZeneca‘s vaccine could be approved in China by mid-2021, Reuters reports, citing comments made in November by Leon Wang, head of the company’s China operation.
The U.S. has set aside 5.8 million Moderna doses for states this week, marking a 1.5-million-dose boost from the 4.3 million doses the company supplied last week, according to the CDC. Pfizer, for its part, provided just under 4.4 million vaccine doses this week, up 70,000 doses from what it delivered last week. “Yesterday, we announced a 16% increase in supply flowing to states every week for the next three weeks to a minimum of 10 million doses per week,” White House COVID-19 response adviser Andy Slavitt said Wednesday at a press event.
Pfizer and Johnson & Johnson want to block shareholders from voting on resolutions that would force the companies to reveal the effect of government funding on vaccine pricing and access, Newsweek reports. Members of the shareholder activist group the Interfaith Center on Corporate Responsibility asked the companies for government funding receipts and how that funding could affect pricing. Pfizer and J&J both filed “no action requests” with the Securities and Exchange Commission in December. They’ve claimed the proposals attempt to “micromanage” the companies. Story
Against the pandemic backdrop, drugmakers have increasingly turned to PR communications to get out day-to-day messages about drug supply, patient support and more. For Evoke Kyne, whose client list includes COVID-19 bigwigs Johnson & Johnson and AstraZeneca, that means 20 recent hires across its specialty creative, digital, social and earned media teams, plus double-digit revenue growth in 2020. “In a time last year when many people couldn’t find work, our category found an abundance of needs,” Maryellen Royle, partner and global head of operations, said. Story
UPDATED: Monday, Feb. 1 at 3:05 p.m. ET
China’s Clover Biopharmaceuticals parted ways with GlaxoSmithKline’s adjuvant in favor of one from Dynavax. Clover had been testing its vaccine candidate with adjuvants from both companies, but said it had settled on Dynavax’s after weighing “manufacturing considerations” and reviewing vaccine data from phase 1, which assessed both shot boosters. Clover and Dynavax expect to start a phase 2/3 trial in the first half of the year. Story
Pfizer and Moderna will continue to lead COVID-19 vaccine sales, but AstraZeneca, Novavax and Johnson & Johnson’s shots have blockbuster potential, too, analysts figure. Despite lower overall efficacy in phase 3 than its mRNA competitors, J&J’s shot still provides a “compelling one-dose profile with much more straightforward distribution and logistics,” SVB Leerink analyst Mani Foroohar, M.D., wrote Monday. AstraZeneca, for its part, could snag $1.9 billion in vaccine revenues this year, followed by $3 billion in 2022, fellow SVB Leerink analyst Andrew Berens predicted. Story
The Mayo Clinic and nference are expanding their data analytics partnership to tackle research projects in digital pathology and heart rhythm diagnostics. Last January, Mayo tapped nference to build an artificial intelligence-powered engine that would transform years of clinical records into an annotated database. In 2020, the companies used the system to answer questions about the COVID-19‘s long-term complications and more. For instance, nference’s platform found the virus’ favored ACE2 receptor spanned multiple tissues, from the airway to the gastrointestinal tract. Story
Pharma has gone all in on digital solutions during the COVID-19 pandemic, but that may not be working out so well for doctors, recent research from Indegene found. Forty-nine percent of physicians polled expressed dissatisfaction with the industry’s social media engagement. Meanwhile, 46% of doctors said they weren’t happy with marketing emails and 42% took issue with telephone sales calls with sales reps. Another 39% of physicians said they were unsatisfied with both websites and webinars. Story
The World Health Organization inked a deal with India’s Premier Medical Corporation to help automate the company’s manufacturing capacity. The agreement, which covers R&D, technology transfer and scale-up provisions, supports Premier’s goal of delivering at least 250 million test kits at less than $2.50 apiece—less than half the cost of the rapid antigen tests from Abbott and SD Biosensor that are already prequalified by WHO. The company has current capacity for 3 million tests per month, which it hopes to boost to 10 million per month by 2021’s third quarter. Story
China arrested more than 80 suspects thought to have manufactured and sold at least 3,000 counterfeit COVID-19 vaccines, The New York Times reports, citing China’s state-run news agency, Xinhua. The primary suspect, identified by the surname Kong, had been injecting saline into vials and pawning them off as vaccines since September, Xinhua said.
The U.S. has given about 30 million vaccine doses and, as of Sunday, has been averaging more than 1.3 million vaccinations per day in the past week—surpassing an average of less than one million per day two weeks earlier, The New York Times reports. The U.S. would be in good shape were it not for looming virus variants. With the possibility that those mutations become dominant this spring, “we really have to vaccinate the American population by late spring, early summer,” Peter Hotez, M.D., Ph.D., a vaccine scientist at Baylor College of Medicine in Houston, said.
And just as the U.S. was correcting the course on its vaccine rollout, a blizzard hit. New York City is postponing COVID vaccinations scheduled for Monday and Tuesday as snow blankets the city, Mayor Bill de Blasio said. The winter storm has also hamstrung vaccination efforts in New Jersey, Washington, Philadelphia and other areas, The New York Times reports.
Rep. Stephen Lynch, D-Massachusetts, tested positive for COVID-19 after getting both doses of Pfizer and BioNTech‘s shot, the lawmaker’s spokesperson said. Lynch is asymptomatic and feeling fine, and he’ll self-isolate and vote by proxy in Congress this week, she added. It can take a few weeks for the body to develop immunity after vaccination, the CDC has noted. “That means it’s possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and still get sick,” the agency said.
UPDATED: Monday, Feb. 1 at 11:40 a.m. ET
Eli Lilly has joined forces with local health systems to launch dedicated infusion centers serving central, northern and now, southern Indiana—part of a bid to increase access to antibody drug bamlanivimab. The rollout of Lilly’s antibody drug and Renegeron’s antibody cocktail has been slow, with infusion presenting one significant barrier to access, experts have noted. Lilly’s local partners include the State of Indiana, Community Health Network, Eskenazi Health, Franciscan Health, Saint Joseph Health System and more. Story
Amid a European supply kerfuffle, AstraZeneca will send 9 million more vaccine doses to the European Union in the first quarter, increasing deliveries from February to March by about 30%, European Commission chief Ursula von der Leyen said. Deliveries will also kick off a week earlier than expected, she said on Twitter. The company is also working to boost production capacity in Europe, von der Leyen added.
Step forward on vaccines.AstraZeneca?ref_src=twsrc%5Etfw”>@AstraZeneca will deliver 9 million additional doses in the first quarter (40 million in total) compared to last week’s offer & will start deliveries one week earlier than scheduled.
The company will also expand its manufacturing capacity in Europe.
— Ursula von der Leyen (@vonderleyen) January 31, 2021
Bayer will produce German compatriot CureVac’s mRNA shot starting in 2022. The company has “necessary capacities” in place to crank out the experimental vaccine, CVnCoV, and aims to produce 160 million doses in the first 12 months, Stefan Oelrich, Bayer’s pharmaceutical head, told reporters. CureVac pushed its shot into a phase 3 trial in December and has set the goal to produce several hundred million vaccine doses through 2021, CEO Franz-Werner Haas said. Story
Speaking of CureVac, the mRNA specialist said Monday that it had started setting up manufacturing capacity with CDMO Rentschler Biopharma—on the hook for large-scale production of the formulated mRNA for CureVac’s shot. The companies in December agreed to set aside production lines at Rentschler’s site in Laupheim, Germany, where the CDMO aims to crank out more than 100 million doses of CureVac’s vaccine per year.
Meanwhile, Pfizer‘s German mRNA partner BioNTech will boost second-quarter vaccine deliveries to the European Union by up to 75 million doses, the company said Monday. The move comes as Germany and other EU member states lag behind Israel, the UK. and the U.S. with their vaccine rollouts. AstraZeneca recently said it would cut initial deliveries to the bloc, citing manufacturing shortfalls in Europe, while Pfizer and BioNTech said they would temporarily squeeze early shipments to Europe, Canada and other countries as they complete a factory upgrade in Belgium.
The World Health Organization’s equitable vaccine distribution scheme Covax plans to distribute 35.3 million doses of AstraZeneca‘s vaccine to to 36 Caribbean and Latin American states from mid-February to the end of June, WHO’s regional office said. WHO is expected to finish its review of AZ’s shot for a possible emergency listing in the next few days, the Pan American Health Organization said. Meanwhile, Bolivia, Colombia, El Salvador and Peru will also get a combined 377,910 doses of Pfizer and BioNTech‘s mRNA shot from mid-February.
Vaccine specialist Dynavax Technologies tapped the Coalition for Epidemic Preparedness Innovations (CEPI) to support supply of Dynavax’s CpG 1018 advanced adjuvant, pegged for use in COVID-19 vaccines developed by CEPI grantees. CEPI will provide a forgivable loan of up to $99 million for the potential manufacture of “hundreds of millions” of vaccine doses through 2021, the companies said.
The dry-ice needed to transport Pfizer‘s vaccine at ultra-cold temperatures is putting a squeeze on the frozen food industry, Modern Retail reports. The same week in December when dry ice manufacturer ThermaFreeze’s stock jumped to $32.25, up from $0.80 per share the previous month, frozen waffle maker Evergreen said it would delay shipments of the breakfast food thanks to a lack of dry ice at its warehouse—and that’s just one example.
UPDATED: Friday, Jan. 29 at 11:20 a.m. ET
Johnson & Johnson’s single-dose vaccine candidate was just 66% effective overall in moderate to severe COVID-19 cases, with that number rising to 85% in severe disease, phase 3 data showed. The shot proved 72% effective at preventing moderate to severe COVID-19 in the U.S., but its overall effectiveness fared worse outside the country, with 66% efficacy in Latin America and 57% efficacy in South Africa. The shot performed better against severe disease, displaying “(c)omplete protection against COVID-19 related hospitalization and death” after 28 days, J&J said. Story
Speaking of J&J, the company plans to deliver some 200 million vaccine doses to the U.S., should its candidate snare an emergency nod. The order volume appeared in a footnote in a Government Accountability Office report published Thursday. Meanwhile, a spokesperson for the company told BNN Bloomberg that J&J plans to supply the U.S. with 100 million doses in the first half the year.
Amid supply concerns in Europe, AstraZeneca‘s COVID-19 vaccine won a conditional approval from regulators there on Friday. The approval was widely expected, and the regulators didn’t add an age restriction for people 65 and older. There had been a question about the age group after German officials raised concerns over a lack of data. AZ’s shot is now authorized for people 18 and older in Europe.
Novavax’s shot candidate hit 89.3% efficacy in phase 3. In the 15,000-subject UK. study, there were 56 COVID-19 cases in the placebo arm, versus six in the vaccine group at the interim analysis. Thirty-two of those cases were infected with the virus variant first ID’d in the UK., with a post hoc analysis putting the efficacy against the B.1.1.7 variant at 85.6%, compared with 95.6% in older variants, Novavax said. Meanwhile, the shot was only 49.4% effective against the South African variant, data from a 4,400-subject phase 2b showed. Story
First Sanofi, now Novartis: The Swiss Pharma juggernaut has signed on to help Pfizer and BioNTech crank out their COVID-19 vaccine, Comirnaty. Under the deal, BioNTech will use Novartis’ production facility in Stein, Switzerland. Manufacturing will start in the second quarter, with deliveries pegged to kick off in Q3. Novartis will receive bulk mRNA active ingredient from BioNTech and fill it into vials, which it will then bounce back to BioNTech for global distribution. Novartis is in “advanced” talks to support other companies developing COVID vaccines and drugs, too. Story
South Korea’s Ministry of Food and Drug Safety recommended Celltrion’s antibody therapy Regkirona, also known as CT-P59, to treat patients with moderate disease, plus those with mild symptoms who are in high-risk groups, Korea Biomedical Review reports. More data is needed to confirm the drug’s preventative effect, as well as its efficacy in patients with mild COVID-19, an advisory committee reviewing Regkirona said. The drug regulator could authorize Regkirona once Celltrion submits phase 3 data, the head of the review committee said.
Pfizer and BioNTech‘s mRNA shot Comirnaty looks as safe in the real world as it did in clinical trials, and no new side effects have emerged, the European Medicines Agency said in its first safety update on a COVID-19 vaccine. EMA’s safety committee, PRAC, assessed reports of deaths after receiving the shot, including deaths in frail, older patients, and found that there was no link between those cases and the vaccine.
Amid an ongoing vaccine supply row with the European Union, AstraZeneca published the contract it signed with the bloc last August. The contract allows EU member states access to up to 300 million vaccine doses, with the option to buy 100 million more. AZ last week said it planned to cut initial deliveries to the EU from 80 million doses to 30 million, blaming production shortfalls at its European manufacturing operations.
The UK.’s top priority is to vaccinate its own population, but the country will help its “friends and neighbors” with shot supplies where it can, The Herald reports, citing Home Office Minister Lucy Frazier. The move comes after the European Union called on AstraZeneca to divert vaccine doses made in the UK. to Europe. Meanwhile, Scotland plans to start publishing AstraZeneca‘s supply data next week in the interest of full transparency, the country’s First Minister, Nicola Sturgeon, said.
AstraZeneca, for its part, offered the European Union an extra 8 million vaccine doses to help ease supply concerns, but that number is still far below what the bloc is looking for, an EU official told Reuters. The drugmaker said it could potentially bump up first-quarter deliveries to 39 million doses, but that still comes in well below the 80-million-dose minimum it had originally promised to deliver in that time, the official—who was directly involved in the talks—told Reuters.
UPDATED: Thursday, Jan. 28 at 3:10 p.m. ET
Amid concerns about supply of AstraZeneca‘s COVID-19 vaccine in Europe, a new wrinkle has emerged for the forthcoming rollout. German officials recommended against the vaccine’s use in people 65 and older, citing a lack of evidence in the age group, UPI reports. AstraZeneca responded that the conclusion is “not an accurate reflection of the totality of the data.”
After news that AZ won’t be able to fulfill its first-quarter order in Europe, officials are facing pressure to restrict exports of COVID-19 vaccines, Sky News reports. Officials are also investigating the plant in Belgium at the root of the manufacturing issue.
The South African COVID-19 variant that has raised scientists’ concerns has been found in the U.S., the Wall Street Journal reports. Two people with no connections and with no travel history to South Africa have been identified to have the variant, according to the report.
Supply shortfalls aren’t just hitting Europe. Canada’s first-quarter deliveries of Pfizer‘s mRNA could come up 500,000 doses short, an official said.
UPDATED: Thursday, Jan. 28 at 11:45 a.m. ET
Swiss Pharma Novartis is in talks with several companies to potentially chip on manufacturing for COVID-19 diagnostics and vaccines, a company spokesperson told Fierce Pharma. It isn’t the company’s first pandemic push, though. Last year, Novartis’ gene therapy unit AveXis agreed to produce an early-stage COVID-19 gene therapy under investigation by researchers at Massachusetts General Hospital and Massachusetts Eye and Ear. Story
Separately, the U.S. government is considering leveraging the Defense Production Act to tap drugmakers to produce Pfizer/BioNTech and Moderna‘s vaccines. The Biden Administration is “not afraid to explore every option to get more vaccines to the public as quickly as possible,” White House senior COVID-19 advisor Andy Slavitt said at a media briefing this week.
French vaccine specialist Valneva kicked off production of its inactivated, adjuvanted vaccine candidate. At the same time, the company announced it had finished enrollment for its phase 1/2 clinical trial and expects to report initial results in April. The company has recruited 150 healthy adults between the ages of 18 to 55 for the study, which launched in December. Valneva has agreed to supply up to 190 million doses of its shot to the UK. and is in “advanced” talks with the European Commission to provide up to 60 million doses, should the vaccine win out in the clinic.
The European Union should “explore all options” and use “all legal means” to ensure it gets the vaccines it ordered, European Council President Charles Michel wrote in a letter to four EU leaders. This could result in the EU blocking vaccine exports if they violate existing contracts between drugmakers and the bloc, an EU official told Reuters. The European Commission on Friday is expected to outline criteria it would use to assess those exports.
The Belgian government on Thursday said it had inspected the local Novasep facility at the center of AstraZeneca‘s European vaccine delivery woes. Experts from the country’s federal medicine agency will now work with Dutch, Spanish and Italian experts to deliver a report in the next few days, aiming to assess whether production shortfalls are truly behind AstraZeneca‘s reduced shipments, a spokesperson for Belgium’s health minister said. AZ last week said it would cut initial shot deliveries to Europe from 80 million to 31 million doses, citing reduced manufacturing yields in Europe.
AstraZeneca has rejected the EU’s recommendation to divert vaccines from its UK. manufacturing sites to Europe, Bloomberg reports. The European Union has alleged that AstraZeneca used EU funding to boost production in the UK. “We regret the continued lack of clarity on the delivery schedule and request a clear plan from AstraZeneca for the fast delivery of the quantity of vaccines that we reserved for the first quarter,” EU health commissioner Stella Kyriakides said.
It’s now suspected that anti-vaxxers were behind a bomb hoax that forced Wednesday’s evacuation of a Wockhardt facility in Wrexham, Wales, where the company is finishing doses of AstraZeneca‘s vaccine, The Telegraph reports. “Unfortunately there are anti-vaxxers out there, which is why security is being taken so seriously at this plant,” a source told the British daily. The contents of the package, which weren’t actually viable as a bomb, are now being investigated to track down the responsible parties. Wockhardt’s manufacturing schedule wasn’t disrupted.
The UK. will offer genomic sequencing capacity to other countries to support the tracking of coronavrius variants, Pharma Times reports. The so called New Variant Assessment Platform will be led by Public Health England alongside NHS Test and Trace, plus academic partners and the World Health Organization’s SARS-CoV-2 Global Laboratory Working Group. Countries will be able to apply for assistance through WHO if they don’t already have an established channel in the UK., the news outlet said.
Pfizer and BioNTech‘s vaccine was largely effective against virus mutations first identified in the UK. and South Africa, a lab study found. While the antibodies generated by the vaccine worked slightly less well against mutations found in the South African variant, the “findings do not indicate the need for a new vaccine to address the emerging variants,” Pfizer said. Meanwhile, both Moderna and Pfizer are investigating booster shots to tackle virus variants.
UPDATED: Wednesday, Jan. 27 at 3:07 p.m. ET
Sanofi signed on to produce more than 100 million doses of Pfizer and BioNTech‘s vaccine in Europe this year, with the first batches pegged for delivery from the drugmaker’s Frankfurt, Germany, site by August, a Sanofi spokesperson told Fierce Pharma. Sanofi’s own vaccine candidates remain top priority, he added. A phase 2b study of Sanofi and GlaxoSmithKline’s experimental shot is scheduled to start next month, and the company also has a Translate Bio-partnered mRNA candidate in the pipeline. Story
Regeneron’s antibody cocktail was mostly effective against viral variants first identified in the UK. and South Africa, Regeneron and Columbia University researchers independently confirmed in lab tests. Both antibodies in the company’s imdevimab and casirivimab cocktail demonstrated neutralizing activity against the B.1.1.7 variant, first discovered in the UK. The cocktail was effective against the South African variant, B.1.351, too, although the potency of casirivimab was reduced.
Eli Lilly is teaming up with GlaxoSmithKline and its partner Vir Biotechnology to test Lilly’s authorized antibody drug, bamlanivimab, in combination with GSK and Vir’s experimental antibody therapy VIR-7831. The companies will assess the combo in Lilly’s Blaze-4 trial to determine whether the two neutralizing antibodies bind to different epitopes of the coronavirus’s spike protein, which could improve potency and lower the odds of viral variants evading treatment. Story
Spanish drugmaker PharmaMar’s myeloma drug plitidepsin displayed anti-SARS-CoV-2 activity 27.5 times more potent than Gilead Sciences’ Veklury (remdesivir) in human cells, researchers from the Icahn School of Medicine at Mount Sinai and the University of California, San Francisco found. The researchers published their study in Science and, in a separate paper posted on bioRxiv, said the drug also showed antiviral activity against a virus variant first identified in the UK. PharmaMar says it’s now in talks with regulators to launch a phase 3 study of plitidepsin in COVID. Story
CDMO Lonza is on track to get two more production lines for Moderna‘s vaccine up and running at its Visp, Switzerland, site this quarter, though it may take “a couple months” for the site to reach “cruising speed,” CEO Pierre-Alain Ruffieux told reporters Wednesday. The company recently said it started manufacturing work using its first new Swiss line; once the other two become operational, the company will have total capacity for 400 million doses per year across Europe and the U.S. Story
AstraZeneca tapped virtual trial specialist Care Access Research to hustle along a U.S. study of the company’s late-stage monoclonal antibody combo, AZD7442. Care Access will leverage its siteless approach for the phase 3, which is targeting more than 1,000 patients in the U.S. and the UK. The company’s so called “Mobile Sites on Demand” capability brings research—including people, equipment, software and processes—to places and communities that would otherwise have limited access to clinical studies. Story
Police evacuated Wockhardt’s Wrexham, Wales, facility—tapped for fill-finish work on AstraZeneca‘s vaccine—after the company received a suspicious package, the BBC reports. A bomb squad was deployed, with police later stating the package was made safe and that its contents would be “taken away for analysis.” Wockhardt said its staff was able to return, adding that its production schedule hadn’t been disrupted.
Europe cleared Abbott Laboratories’ rapid Panbio antigen test for both self-performed screening under supervision and widespread use by people without COVID-19 symptoms. The lateral flow test, which is similar to Abbott’s U.S.-authorized BinaxNOW test, uses a nasal swab, which is plugged into the small, portable device to deliver a visual result in about 15 minutes. Abbott plans to pair its rapid tests with a smartphone app called Navica that will allow people to display their results. Story
UPDATED: Wednesday, Jan. 27 at 11:30 a.m. ET
Pfizer and BioNTech are working a booster shot to tackle coronavirus variants, Pfizer told Reuters. “We are already laying the groundwork to respond quickly if a variant of SARS-CoV-2 shows evidence of escaping immunity by our vaccine,” the company said. Meanwhile, the company still needs work with regulators to hammer out studies for the booster. Story
The U.S. aims to buy another 200 million doses from Pfizer and Moderna, which would raise the country’s total supply to 600 million doses, President Joe Biden said. The move comes as Biden confirmed the government will boost the number of doses going out to states from 8.6 million per week to 10 million for the next three weeks. Story
AstraZeneca reportedly bailed on a meeting with the European Union to talk about the reduction in its vaccine delivery volume, The Irish News reports, citing an EU official. The European Union would “insist on them” coming back for discussions should AZ’s vaccine get approved, the official said. Meanwhile, ABC News reported that AstraZeneca said it hadn’t pulled out of talks and was planning for a meeting later Wednesday.
The story took another turn when Austrian health minister Rudolf Anschober told reporters that AstraZeneca had simply delayed the meeting. “AstraZeneca has postponed today’s round of negotiations until tomorrow,” he said. “From my point of view that is not a big problem.”
Meanwhile, AstraZeneca never committed to a hard timeline for its vaccine deliveries in Europe, CEO Pascal Soriot told la Repubblica Tuesday. “Our contract [with the European Union] is not a contractual commitment. It’s a best effort,” he said. “In fact, getting there, we are a little bit delayed.” Because the UK. inked its purchase with AstraZeneca early, the company had a “head start” on resolving supply chain issues that are now plaguing the EU, Soriot said. Story
Meanwhile, some of the details Soriot revealed in his interview were confidential, Reuters reports, citing an EU official. The bloc is now requesting that AstraZeneca publish its contract with the European Union, the official said.
Japan’s JCR Pharmaceuticals will produce 90 million doses of AstraZeneca and the University of Oxford’s vaccine, Nikkei Asia reports. JCR will then send the doses it makes to Japanese compatriots Daiichi Sankyo and Meiji for finishing and packaging, though it will likely take until May for the locally produced vaccine to be distributed, Nikkei said. The country in December agreed to purchase 120 million doses of the shot.
Bharat Biotech’s vaccine Covaxin neutralized a UK. variant of the coronavirus, a lab study posted on bioRxiv showed. The company, alongside the Indian Council of Medical Research and the National Institute of Virology, Pune, assessed blood samples from 26 people who’d received Covaxin against the mutant virus. Bharat’s vaccine was approved in clinical trial mode earlier this month, raising concerns about the shot’s efficacy.
India’s Dr. Reddy’s Laboratories canned its COVID-19 study of Fujifilm’s flu med Avigan in patients with moderate to severe symptoms in Kuwait after the drug failed to hit its primary endpoint. Patients on Avigan saw sustained improvements in oxygen levels at the seven-day mark, compared to the placebo arm’s eight. The company plans to continue a phase 3 trial in the U.S. in an outpatient setting.
UPDATED: Tuesday, Jan. 26 at 3:19 p.m. ET
Regeneron unveiled early phase 3 data supporting the use of its antibody cocktail for “passive vaccination.” REGEN-COV was 100% effective at preventing COVID-19 symptoms versus placebo in the trial, which assessed the drug in people at high risk of contracting the disease from exposure to infected family members. Passive vaccination with the drug slashed the overall rate of infection by half, and infections in patients on the cocktail were asymptomatic, brief and had a “short duration” of viral shedding, which can lead to the illness’ spread, the company said. Story
Meanwhile, a combination of two Eli Lilly antibodies led to a 70% reduction in the risk of COVID-19 hospitalization or death, phase 3 data showed. In the study of more than 1,000 high-risk patients recently diagnosed with COVID-19, 11 people given a combination of bamlanivimab and etesevimab were hospitalized and none died, compared with 26 hospitalizations and 10 deaths in the placebo arm. The antibody duo also reduced viral load and improved resolution of symptoms. Story
Ahead of Johnson & Johnson’s vaccine readout, now pegged for early next week, chief financial officer Joe Wolk said the company is “optimistic” and expects to deliver “a very robust data set.” An emergency nod for the company’s single-dose shot could help ease early vaccination efforts. AstraZeneca, Pfizer and Moderna‘s vaccines all require two doses, and with many countries demanding more, supply is struggling to keep up. J&J, for its part, aims to deliver 100 million doses to the U.S. by the end of June and 200 million to the EU by year-end. Story
Speaking of Johnson & Johnson’s supply commitments, the company is “very comfortable” with those deals and “well on track” to make its deliveries, CFO Wolk said on the company’s Tuesday conference call with analysts. Aside from its commitments to Europe and the U.S., the company has also pledged 100 million doses to developing countries through Gavi, the Vaccine Alliance, with plans to start those deliveries in the year’s second half. Future supply agreements present “somewhat of a fluid situation,” Wolk said, adding that the volume of doses would affect the selling price. Story
Pfizer shouldn’t count an extra sixth dose in vials of its vaccine toward its U.S. supply contract “until the supply of specialized syringes meets that of Pfizer vials,” watchdog Accountable Pharma said Tuesday. Pfizer was originally receiving $97.50 for the five doses in each vial but now stands to make $117 per vial “by counting an extra dose that may or may not be extractable,” the watchdog said. BD, the world’s largest syringe maker, recently told Reuters it lacks capacity to “substantially” boost U.S. supplies of low dead space syringes, needed to pull Pfizer‘s sixth dose.
States may start receiving more vaccines next week, The Washington Post reports, citing two people close to the plan. Weekly shot allocations are expected to jump from about 8.6 million doses to 10 million doses—an increase of about 16%. White House coronavirus response coordinator Jeff Zients is expected to call governors Tuesday to inform them of the boost, possibly thanks to the release of more Moderna doses, according to The Post’s sources.
After 14 to 18 days, people who received one dose of Pfizer‘s vaccine were 33% less likely to be infected, Clalit, Israel’s largest state-mandated health services organization, said. Clalit compared 200,000 people ages 60 and up who’d received their initial shot with another 200,000 people who hadn’t been vaccinated. Maccabi Health Services separately reported a 60% drop in infectious 13 to 21 days after patients received their first shot. Among the 428,000 Israelis who got both doses, only 63 people became infected a week later, the Israeli Health Ministry and Maccabi said Monday.
A fast-spreading coronavirus variant first identified in Brazil has cropped up in the U.S., Minnesota officials announced Monday. Officials said they’d identified one person infected with the so called P.1 variant, and that the individual in question had a “recent travel history to Brazil.” Separately, Minnesota has detected eight cases of a variant first ID’d in the UK., which could become dominant in the U.S. sometime in March, the CDC has warned. Another mutation that emerged in South Africa has yet to appear stateside.
Meanwhile, the Centers for Disease Control and Prevention is stepping up surveillance and study of viral mutations, director Rochelle Walensky told Fox News. Working with the National Institutes of Health, the FDA and the Pentagon, the CDC will work to assess the effect of vaccines and therapeutics on coronavirus variants, she said. Concerns have mounted this week over the possibility that the variant detected in South Africa may evade antibody treatment and reduce the efficacy of vaccines.
UPDATED: Tuesday, Jan. 26 at 11:37 a.m. ET
Following a supply cut in Europe, AstraZeneca has offered to kick off vaccine deliveries on February 7, about a week earlier than originally planned, two European Union officials told Reuters. The EU has also pressed the company to divert doses made in the UK. to the European Union, at least through March, though AZ hasn’t said whether it will go that route. One of the sources, briefed on the talks, told Reuters AZ had revised its upward supply goals for February, while the second official, involved directly in discussions, said there was no offer to boost supplies.
On the heels of AstraZeneca‘s delivery reduction, the European Union is telling Pfizer and other drugmakers that they need permission from the bloc to export vaccine doses to the UK., The London Economic reports. Pfizer, which is producing doses of its shot Comirnaty in Belgium, will need to offer “early notification” anytime it wants to ships EU-made doses to non-bloc countries, Stella Kyriakides, Europe’s health commissioner, said.
Serum Institute of India is set to deploy 3 million AstraZeneca doses to Saudi Arabia in about a week, company CEO Adar Poonawalla told Reuters. Each dose will cost $5.25, he added. SII doesn’t plan to divert any of its Covishield doses to Europe, despite AstraZeneca‘s recent vaccine supply woes there, because the move would siphon shots away from places like India and Africa, Poonawalla said.
AstraZeneca‘s shot is more than 8% effective in people over the age of 65, Germany’s health ministry clarified after a major mixup by local news outlets Bild and Handelsblatt. The newspapers published separate stories citing the low figure, with Bild suggesting German officials were worried the shot would fail to win approval with the European Medicines Agency. It seems the journalists confused the 8% of patients in AZ’s trial who were between the ages of 56 and 69 with efficacy data, the country’s health ministry said.
The Bild and Handelsblatt reports are “completely incorrect,” an AstraZeneca spokesperson told German news outlet DW. The company pointed to vaccine data published in The Lancet that showed 100% of older adults generated spike-specific antibodies after their second dose. The UK.’s Joint Committee on Vaccination and Immunisation and the country’s Medicines and Healthcare products Regulatory Agency both vouched for the shot’s efficacy in people over the age of 65, AZ added.
Meanwhile, “we could and should have been better prepared for this pandemic,” AstraZeneca chief Pascal Soriot said on a virtual panel, blasting the “me first” approach that many countries have taken. In particular, he called out subpar international collaboration and pandemic preparedness. Looking forward, world leaders should adopt lessons learned from COVID-19 and invest more heavily in early detection and prevention, he said.
Sweden halted its Pfizer vaccine payments as it works to determine just how many doses are in each vial, local newspaper Dagens Nyheter reports. The country wants to know whether it’s been charged for an extra sixth dose found in vials—a dose Europe’s drug regulator approved earlier this month—rather than the five doses it agreed to. The country is also pushing Pfizer and the European Commission to reach a definitive agreement on the dose count for each vial.
Providing its shot in a six-dose vial is Pfizer‘s best chance at stretching its vaccine supplies, company board member and former FDA commissioner Scott Gottlieb told CNBC. “The bottom line here is that this is a very scarce resource. We need to make sure every dose gets used,” he said. With approval for that sixth dose in place, Pfizer can now deliver 120 million doses in the first quarter, rather than 100 million, he said—but there’s a catch: To pull out that extra dose, pharmacists need special low dead space syringes.
Moderna has delivered 30 million vaccine doses to the U.S. as of Tuesday, Bio Stocks reported on Twitter. The company is still on track to roll out 100 million doses by March and 200 million by the end of June.
Company has supplied over 30M doses to U.S. Govt to date.
Remains on track to deliver 100M doses by end of March.
Remains on track to deliver 200M doses by end of June
— Bio Stocks™ (@BioStocks) January 26, 2021
Meanwhile, Johnson & Johnson aims to unveil phase 3 data on its single-dose vaccine hopeful next week, CFO Joseph Wolk said. Wolk restated that the price per regimen wouldn’t surpass $10, adding that the company plans to onboard seven vaccine production facilities by end of the second quarter.
*J&J TO REPORT VACCINE DATA BY EARLY NEXT WEEK: CFO
*J&J TO ONBOARD 7 VACCINE PRODUCTION FACILITIES BY Q2 END: CFO
*J&J CFO: GUIDANCE DOES NOT INCLUDE COVID-19 VACCINE SALES
— zach (@zbiotech) January 26, 2021
The World Health Organization now recommends that clinicians put COVID-19 patients in the awake prone position, on their front, to improve oxygen flow, and it’s also vouching for the use of low-dose anticoagulants to prevent the formation of blood clots, WHO spokeswoman Margaret Harris said at a U.N. briefing. For patients who continue to display symptoms after recovery, WHO is pushing for the use of pulse oximetry, used to measure oxygen levels, to determine whether a person should be admitted to the hospital.
UPDATED: Monday, Jan. 25 at 3:15 p.m. ET
Merck & Co. canned both of its COVID-19 vaccine candidates, citing lackluster efficacy data in phase 1. The candidates, V590 and V591—developed with IAVI and picked up in Merck‘s Themis buyout, respectively—triggered immune responses inferior to those seen in infected patients. The responses were also weaker than those spurred by rival vaccines. Merck will now shift its attention to two experimental therapies in the works—a fusion protein it snagged in its OncoImmune takeover, and the Ridgeback Bio-partnered antiviral molnupiravir. Story
While Moderna‘s vaccine has so far stood up against two fast-spreading coronavirus variants, it’s less effective against the more recently identified South African mutation, prompting the company to weigh a third shot and variant-specific booster. The variant candidate, designed to target the South African mutation, B.1.135, is moving into preclinical trials and a phase 1 U.S. study, Moderna said Monday. Meanwhile, Pfizer and BioNTech in December said testing had shown their mRNA vaccine, Comirnaty, consistently “neutralized multiple mutant strains.” Story
Upstart generics maker Civica Rx is plowing $124.5 million into a sterile injectables manufacturing plant in Petersburg, Virginia—part of its partnership with Phlow Corp to crank out essential meds for COVID-19. The 120,000-square-foot facility will have capacity for 90 million vials and 50 million pre-filled syringes per year, focusing on drugs for COVID-19 patients as well as meds used in emergency rooms, intensive care units and surgeries. The facility will ultimately employ more than 180 staffers once it comes online, sometime in the next three years, Civica said. Story
Scientists examining the immune system’s effect on the microbiome found two molecules that could offer new treatment strategies for asthma and COVID-19. Upon transplanting gut bacteria from an immune-deficient mouse model into normal mice, the team found that the bacteria displayed enhanced metabolism of the molecule L-tyrosine, creating a byproduct called p-cresol sulfate (PCS). Both supplements protected against lung inflammation in asthma models and animal models of acute respiratory distress syndrome (ARDS)—a common byproduct of severe COVID-19. Story
President Joe Biden‘s quest to roll out 100 million vaccine doses in his first 100 days in office is “a floor… not a ceiling,” which “reflects the realities of what we face, what could go right but also what could go wrong,” Surgeon General pick Vivek Murthy told ABC. Approval of Johnson & Johnson’s single-dose vaccine would help meet that goal, but it isn’t essential given current supplies of Pfizer and Moderna‘s shots, he said. Meanwhile, establishing better distribution channels via mobile units and strategically-placed community vaccination centers will be equally essential, he added.
Italy is weighing legal action against AstraZeneca, which committed a “serious contractual violation” on Saturday when it told the country to expect 3.4 million vaccine doses in the first quarter, down from the 8 million it had hoped for, Prime Minister Giuseppe Conte said. The delivery reduction comes after Italy’s COVID-19 commissioner, Domenico Arcuri, said the country was bracing for a 29% drop in Pfizer/BioNTech doses after this week.
The FDA rolled back its emergency authorizations for N95 respiratory decontamination systems, cutting down the number of times each mask could be safely reused to just four. Systems from companies like Battelle, Steris and Stryker kill viruses and bacteria on the masks by gassing them with hydrogen peroxide vapor. Early last year, when supplies of personal protective equipment were at a minimum, the agency allowed masks to be reprocessed up to 20 times on certain hardware. Story
When the city of Los Angeles converted Dodger Stadium from a testing center into a mass vaccination site, it temporarily removed about one-third of all government-funded testing in the county, Kaiser Health News reports. Less testing capacity could mean people have to wait longer for appointments, increasing the risk of potential spread. Those delays haven’t happened yet, LA Mayor Eric Garcetti said; still, many health experts caution that testing is just as important as vaccination, especially as a tool to assess the longer-term efficacy of authorized shots.
On the East Coast, New York City will delay opening vaccination centers at Yankee Stadium and Citi Field, thanks to low vaccine supplies, mayor Bill de Blasio said. Another site at the Empire Outlets on Staten Island, originally pegged to open last week, has also been put on hold. On Monday, the city had 19,032 first doses on hand and expected to receive a little less than 108,000 more this week—not nearly enough to keep up with the pace of immunization, de Blasio said.
Want to watch the Miami Heat play? First, you need to pass the sniff test. The Heat will use coronavirus-sniffing dogs to screen fans hoping to attend games at the American Airlines Arena, The Boston Globe reports. The dogs were deployed earlier this season to screen small numbers of guests—mostly friends and family of Heat players and staff, though starting this week, a limited number of ticket holders will be allowed in.
UPDATED: Monday, Jan. 25 at 11:40 a.m. ET
Moderna says its vaccine appears to work against coronavirus variants first identified in South Africa and the UK., citing new results from lab studies assessing the blood of eight patients who received the shot. The study showed no reduction in neutralizing titers against the B.1.1.7 variant, which first cropped up in the UK. And despite a six-fold reduction in neutralizing titers against the South African variant, B.1.351, levels remained above those expected to provide protection, Moderna said.
Humanigen tapped Emergent BioSolutions to speed up production of the drugmaker’s experimental antibody drug lenzilumab. Emergent’s aim is to shore up supplies of the drug, currently in phase 3, ahead of a possible emergency nod in 2021’s first quarter. For its seventh COVID-19 manufacturing tie-up, Emergent plans to leverage a new flex fill line at its Baltimore, Maryland, drug product manufacturing facility.
Korea’s Daewoong Pharmaceutical got a thumbs up to run a phase 3 trial of its oral protease inhibitor, Foistar, in COVID-19 patients. The drug, approved in Korea in 2012 to treat chronic pancreatitis, will be given to 1,012 COVID patients across two Seoul hospitals starting in February. Daewoong has completed a phase 2 study of the drug in patients with mild symptoms, but it did not yield statistically significant data.
The European Medicines Agency could clear AstraZeneca‘s shot for emergency use on Friday, Yahoo! News reports, citing an official from Germany’s health ministry.
Meanwhile, European Union chief Ursula von der Leyen spoke to AstraZeneca CEO Pascal Soriot Monday, clarifying that she expects the British pharma to fulfill its established orders to Europe, her spokesperson, Eric Mamer, said. Soriot said his company was doing everything possible to speed deliveries to Europe, though wider supply problems emerged Monday, Reuters reports.
Over the weekend, health commissioner Stella Kyriakides also wrote a letter to the company seeking “further clarifications,” a Commission spokesman on public health said. In her letter, Kyriakides argued that production scale-ups have to happen “concurrently” with clinical trials to get doses out as quickly as possible, the spokesman said. Story
AstraZeneca also plans to cut supplies to Australia in March after the company said it was facing a “significant supply shock,” the country’s health minister, Greg Hunt, told reporters. Meanwhile, Thailand says it will now receive 150,000 AZ doses rather than an expected 200,000. AZ’s EU delay is tied to reduced yields at a site run by its viral vector manufacturing partner Novasep.
Speaking of Australia, the country on Monday issued a complete approval for Pfizer and BioNTech‘s vaccine, which has largely been cleared for emergency use in countries where it’s available. The country plans to vaccinate some 80,000 people per week starting in late February, Prime Minister Scott Morrisson said.
Pfizer will ship fewer vials of its vaccine to the U.S. than originally planned, thanks to updated FDA guidance allowing pharmacists to extract a sixth dose from the vials, which were originally designed to hold five. The FDA’s decision marked an immediate 20% jump in Pfizer‘s vaccine capacity and now, the company is folding that extra dose into its overall order for 200 million U.S. shots by July, The New York Times reports. Story
So-called “low dead space” syringes are needed to pull out that sixth dose, and Pfizer on Friday finalized a deal with the Biden Administration to track shipments where the specialty injectors are available, a source close to the matter told The Washington Post. Shipments with regular syringes will count toward five doses, while those accompanied by low dead space syringes will count for six. Meanwhile, the administration on Friday said it would leverage the Defense Production Act to secure more of the devices.
Italy tweaked its vaccination plan to prioritize patients’ second dose after Pfizer announced a temporary reduction in deliveries as it completes an upgrade on a Belgian manufacturing plant. Nearly 1.38 million doses have been administered so far, the country’s deputy health minister Pierpaolo Sileri said. Among those, 100,863 people have received their second shot. The delivery adjustment has further prompted Italy to delay vaccination for people over 80 years old by four weeks, with a delay of six to eight weeks for the rest of the population.
Germany bought a combined 200,000 doses of Eli Lilly’s antibody drug bamlanivimab and Regeneron’s antibody cocktail for €400 million ($484 million). The move makes Germany the first European nation to purchase the drugs, which are cleared for emergency use in the U.S.
UPDATED: Friday, Jan. 22 at 3:23 p.m. ET
A new coronavirus variant that emerged in South Africa seems to evade treatment with convalescent plasma and may render the current vaccines on offer less effective, South African researchers wrote in a paper published on bioRxiv. “This lineage exhibits complete escape from three classes of therapeutically relevant monoclonal antibodies,” the researchers said, adding that the variant shows “substantial or complete escape” from antibodies in the plasma of recovered COVID-19 patients. That bodes ill for potential reinfection and the efficacy of spike-based vaccines, they said.
Chances are “very high” that a South African variant of the coronavirus is spreading in the U.S., Illumina CEO Francis deSouza told CNBC. “[The] reality is, in the U.S. we’re doing very little genomic surveillance,” he explained. Sequencing giant Illumina has been working with the CDC to assess the prevalence of a variant first ID’d in the UK., B.1.1.7, across the U.S., though efforts are lagging behind those of other countries. The UK. is sequencing about 10% of the cases they see, while the U.S. currently sequences around 0.3% of positive cases, deSouza said. Story
With a European authorization looming, AstraZeneca notified EU officials this week that its first-quarter vaccine deliveries will be lighter than expected, thanks to “reduced yields at a manufacturing site within our European supply chain,” a company spokesperson told Fierce Pharma. The company aims to supply “tens of millions” of doses to the EU in February and March as it continues to boost production volume, she added. The supply squeeze comes shortly after Pfizer and BioNTech reduced their own EU deliveries as they finish a plant upgrade in Belgium. Story
Eli Lilly is armed with data showing its antibody drug bamlanivimab can prevent symptomatic infections, but because those data are limited to long-term care facilities, where many are now getting vaccines, the drug may continue struggling to catch on. Getting the therapy to patients is its own challenge, SVB Leerink analyst Geoffrey Porges said in a note. “[T]his hinges on quick, targeted distribution… by the U.S. government, which is a significant unknown factor,” he said. The fact that the drug needs to be infused presents another distribution barrier, he added. Story
The pandemic put mRNA vaccines on the map last year, and the technology’s future looks bright, experts said on a Fierce Pharma virtual panel. The manufacturing process for mRNA shots is “universal,” Mariola Fotin-Mleczek, chief technology officer at CureVac, said, meaning different vaccines can be made at the same plant. IAVI’s Swati Gupta thinks scientists will look to explore the platform beyond infectious diseases. Still, researchers shouldn’t give up entirely on proven vaccine tech, Rajeev Venkayya, president of Takeda’s global vaccines business unit, said. Story
Facing the prospect of another year without in-person events, the Biotechnology Innovation Organization (BIO) has made “some staff reductions… to align the organization for the new strategic direction,” CEO Michelle McMurry-Heath, M.D., Ph.D, said. BIO currently has two in-person meetings lined up, though it “expects to offer virtual-only events throughout most of 2021.” Story
Walmart is gearing up to offer vaccines in Georgia, Indiana, Louisiana, Maryland, New Jersey, South Carolina and Texas, plus Chicago and Puerto Rico, a company spokesperson told Reuters. Healthcare workers can already get vaccines through the retailer in New Mexico and Arkansas. The company said Friday that it should be able to deliver 10 million and 13 million doses per month at full capacity.
UPDATED: Friday, Jan. 22 at 11:22 a.m. ET
Bharat Biotech’s COVID-19 vaccine, authorized in India under the name Covaxin, proved safe and induced an immune response in phase 1, data published in the The Lancet Infectious Diseases journal showed. The shot was well-tolerated across dose groups and no serious safety events were reported. All side effects were mild to moderate and were more frequent after the first dose, Bharat said. Bharat’s shot is currently in phase 3 testing and was approved in “clinical trial mode” just one day after India’s drug regulator pressed the company for more efficacy data.
Five people are dead after a fire broke out in a building under construction at Serum Institute of India’s (SII) headquarters in Pune. The blaze may have started as a result of welding work, Fintech Zoom reports, citing Pune’s mayor. Production of AstraZeneca‘s vaccine, which SII is cranking out under the name Covishield, won’t be affected, CEO Adar Poonawalla said.
The European Commission wants clarity from Pfizer over further vaccine delivery delays reported by a handful of European countries, a European Union executive told Reuters. Originally, Pfizer and the Commission said delays would only occur this week as Pfizer scales up its Puurs, Beligum, plant. Italy has been told to now expect a 20% order reduction next week, while the Czech Republic said deliveries could drop by as much as 30% over the next two weeks.
Poland may sue Pfizer if it fails to make its vaccine deliveries on time, Piotr Müller, Poland’s government spokesman, said. Poland received 176,000 doses of Pfizer‘s shot this week, down about 50% from what it expected. Pfizer has said it will temporarily squeeze shot deliveries to Europe and Canada as it completes a plant upgrade in Puurs, Belgium. Poland’s health minister Adam Niedzielski on Thursday said the missing doses would be made up from mid-February, “but if this is not the case then of course legal measures will have to be considered,” Müller said.
France, meanwhile, could impose sanctions on Pfizer and BioNTech if vaccine shipments are further reduced, Clement Beaune, the country’s minister for European affairs, told the Europe 1 radio network. That said, Pfizer‘s vaccine deliveries are expected to return to normal on Monday, he said.
European Union countries are scrambling to get their hands on low dead space syringes that would allow a sixth dose to be extracted from vials of Pfizer and BioNTech‘s vaccine, Yahoo! Finance reports. Europe’s drug regulator on January 8 OK’d the use of a sixth dose from each Pfizer/BioNTech vial, originally meant to hold five. Meanwhile, countries will have to pay for that extra dose regardless of whether they have the syringes to make use of it, since the companies’ supply commitments are “based on delivery of doses, not vials,” Pfizer said.
UPDATED: Thursday, Jan. 21 at 2:10 p.m. ET
The challenges for antibodies from Regeneron and Eli Lilly have been well documented, and now a new wave of antibodies from AstraZeneca and other companies is in development to potentially solve that problem and the separate issue of viral mutations. A Regeneron spokeswoman said the company’s antibody should stand up to known variants, while Eli Lilly’s drug could be susceptible to the South African variant, a representative said. Story
Headlines about low vaccine acceptance have raised alarm in recent months, but amid the rollout, sentiment seems to be improving. In a new Harris Poll, researchers found a 69% acceptance rate for COVID-19 vaccines, just shy of the all-time high of 73%. Story
On the subject of vaccine acceptance, Pfizer and BioNTech are running their own effort with partners to encourage people to get vaccinated. The companies, together with a coalition of health organizations, recently debuted an unbranded awareness campaign that reminds people about the way life used to be. The partners plan 25- to 30-second videos outlining the possibilities following vaccination. Story
While President Joe Biden has his hands full with the COVID-19 pandemic, he has a talented group of advisors, as well. NIAID director Anthony Fauci is staying on board as chief medical advisor, and numerous other experts are joining the effort. Stat has a list of 10 key officials of note.
As the new administration pushes to vaccinate 100 million people in 100 days, new CDC director Rochelle Walensky said COVID-19 vaccines won’t be in every pharmacy by the end of next month, NBC News reports.
UPDATED: Thursday, Jan. 21 at 11:15 a.m. ET
Eli Lilly’s antibody therapy bamlanivimab cut the risk of symptomatic COVID-19 in nursing home residents and staff, data from the company’s phase 3 Blaze-2 trial showed. Among 965 participants who tested negative at the start of the study—299 of them residents and another 666 staff—Lilly linked bamlanivimab to a roughly 57% reduction in risk of contracting symptomatic COVID-19 versus placebo. Among residents specifically, those treated with the drug were up to 80% less likely to develop symptomatic disease, Lilly said.
Adding Roche’s arthritis med Actemra to standard care is no better than standard care alone at cutting death rates among the sickest COVID-19 patients, results from a small Brazilian study published in the British Medical Journal showed. Clinical outcomes among 65 patients who got the drug plus standard treatment failed to beat those in the control arm. The study, though small, contradicts results from a larger UK. trial, which found the drug, as well as Sanofi and Regeneron’s Kevzara, significantly curbed death risk in patients needing intensive care.
Among 189,000 Israelis screened for COVID-19 after receiving their first Pfizer shot, 12,400 people tested positive, the Israeli health ministry said. Most people contracted the virus shortly after their first dose, though around 1,410 tested positive two weeks after that, when the vaccine should have started taking effect. Meanwhile, another 69 people became infected after receiving both doses. The efficacy of Pfizer‘s shot climbs from 52% to 89% between day 15 and day 21 after patients get their first injection, the company has said.
The UK.’s vaccine rollout dodged a major pitfall after rainwaters from Storm Christoph surrounded a Wockhardt manufacturing facility in Wrexham, North Wales, tapped for fill-finish work on AstraZeneca‘s vaccine. Emergency teams subverted flooding by establishing resources like gullies, the leader of Wrexham County Borough said. Meanwhile, a Wockhardt spokesperson told The Irish News that manufacturing hadn’t been interrupted and no water made it inside. Story
South Africa will buy 1.5 million AstraZeneca shots from Serum Institute of India at $5.25 per dose, a senior health administration official said. Deliveries are expected to start before the end of the month. Meanwhile, South Africa is set to receive another slate of vaccines in March through the African Union. Under that deal, the country is expected to pay $3 per dose of AstraZeneca‘s shot.
Japan’s Panasonic is leveraging its refrigerator tech to develop storage boxes for Pfizer‘s vaccine, which must be kept at a frigid -94 degrees Fahrenheit, The Asahi Shimbun reports. The box will incorporate dry ice to keep the shots cool and doesn’t need to be plugged in, the company said. Samples will be ready in March, with a final product expected a month or two after that.
UPDATED: Wednesday, Jan. 20 at 3:08 p.m. ET
The premier of Ontario, Doug Ford, has asked President Joe Biden to share “a million” vaccine doses from Pfizer’s Kalamazoo, Michigan plant, after Canadian officials reported Tuesday that the country wouldn’t receive any Pfizer doses next week and 50% fewer than expected over the next month. Pfizer recently confirmed a brief reduction in shot deliveries to Europe and Canada as it wraps a capacity upgrade on a plant in Puurs, Belgium.
Meanwhile, Italy plans to press charges both “civil and criminal, where possible” against Pfizer for delayed vaccine deliveries linked to its Belgian plant upgrade, Domenico Arcuri, Italy’s special commissioner for the pandemic, said in a statement. Italian officials discussed the delay with Pfizer Tuesday, but the talks “did not have the effect we were hoping for,” Arcuri wrote. He added that Pfizer would not make up the difference in deliveries next week.
President Joe Biden is putting science first in his efforts to curb the pandemic. Human Genome Project head Eric Lander, Ph.D., is Biden‘s pick for presidential scientific advisor, as well as director of the Office of Science and Technology Policy. Frances Arnold, Ph.D.—the first American woman to win the Nobel Prize in chemistry—and Maria Zuber, Ph.D., an expert in geophysics and planetary science, will serve as external co-chairs of the President’s Council of Advisors on Science and Technology. Francis Collins, M.D., will stay on as director of the NIH, while Janet Woodcock, M.D., appears the likely pick for FDA commissioner. Story
One challenge President Biden now faces? Convincing people to take an approved vaccine. Rather than focusing on straight talk and hard stats, vaccine campaigns should instead appeal to peoples’ desire for a return to normalcy, execs from Digitas Health, McCann Health and Ogilvy Health told Fierce Pharma. “To overcome vaccine hesitation, you’re going to have to have a lot of different segmentation and a lot of different messages,” Justin Freid, chief growth and innovation officer at CMI/Compas, added. Story
New York-based Ride Health, which works with a network of transportation providers to get patients to and from hospitals, is partnering with the NIH-backed ACTIV-2 study, assessing treatments for COVID-19, and the NIH-founded COVID-19 Prevention Trials Network. The goal is for Ride Health to provide transportation to and from study sites through its network of COVID-19-equipped providers, meaning drivers will follow guidelines from the CDC, plus state-mandated precautions. Story
India on Wednesday started exporting Serum Institute of India (SII)-produced doses of AstraZeneca’s vaccine to nearby countries. The first exported Covishield doses, set for delivery to Bangladesh, Bhutan, the Maldives, Myanmar, Nepal and the Seychelles, are being donated, India’s Foreign Ministry said. Several of those countries have separate vaccine orders on the docket or are in talks with Serum Institute. Bangladesh, for instance, expects to receive 2 million Covishield doses on Thursday and has separately purchased 30 million doses from SII.
COVID-19 vaccines from Moderna, AstraZeneca, Sinopharm and Sinovac are in the “final phase” of review for a possible emergency use listing by the World Health Organization, Reuters reports, citing an internal WHO document. The agency on December 31 cleared Pfizer and BioNTech’s mRNA-based vaccine for emergency use.
UPDATED: Wednesday, Jan. 20 at 11:16 a.m. ET
As states expand vaccine eligibility to people over the age of 65, older patients enrolled in Novavax’s late-stage shot trial want to be “unblinded” and, if they received placebo, drop out to get Moderna or Pfizer‘s vaccine, The Washington Post reports. Recruitment of trial subjects has slowed, too. Novavax in December set out to recruit 30,000 people for its U.S. trial, including 25% in the over-65 category. As of last week, the company said it had enrolled 9,000 patients and would ask the FDA to weigh data from the same age group in a fully-enrolled UK. trial if it missed its recruitment goal. Story
Pfizer and BioNTech‘s vaccine appears to work against a fast-spreading British variant of the coronavirus, further lab tests showed. The latest study, still awaiting peer review, used a synthetic virus with 10 mutations characteristic of the British variant. The antibodies in the blood of 16 patients who received Pfizer and BioNTech‘s vaccine, Comirnaty, neutralized the pseudovirus as well as they did the older version of the virus.
Japan secured another 24 million doses of Pfizer and BioNTech‘s mRNA vaccine, building on a previous order for 120 million doses, the country’s health ministry said. The expanded order gives Japan enough doses of Pfizer‘s shot to vaccinate 72 million people out of its total population of 126 million, Nikkei Asia reports. Pfizer‘s vaccine is currently the one and only COVID-19 shot under review in Japan. The government is looking to kick off vaccination efforts by late February, Prime Minister Yoshihide Suga said.
Swedish biotech Cyxone has applied to run a phase 2 trial of its rheumatoid arthritis hopeful rabeximod in moderate COVID-19 patients requiring oxygen therapy who are not on mechanical ventilation. The aim is to see whether the drug could cut the risk of severe respiratory symptoms caused by immune responses run-amok. Cyxone will compare two doses of the drug against placebo in 300 subjects, with plans to release initial data in the third quarter of 2021.
The UK. is more than halfway toward its goal of vaccinating 300,000 elderly nursing home residents, and mobile vaccination teams armed with AstraZeneca and the University of Oxford’s shot have helped get it there, The Wall Street Journal reports. The shot doesn’t need to be diluted, making delivery more efficient, plus, patients don’t need to be monitored for anaphylaxis after getting their injection. AZ’s vaccine remains stable for six month at fridge temps and can be used in smaller batches, too. This versatility has led to its prioritization for nursing home residents, Fintech Zoom said.
In searching for a fast-spreading British variant of the novel coronavirus, Californian researchers discovered the state had a mutation of its own, which may be responsible for a recent surge, The New York Times reports. The variant seems to have emerged in July but lay low until November, when it started to spread. The mutation, dubbed CAL.20c, accounted for more than half of the virus genome samples collected in Los Angeles laboratories on Jan. 13, the NYT said, citing a new study that has yet to be published.
The African Union has locked down 270 million vaccine doses beyond the World Health Organization’s Covax distribution scheme, and each dose will cost member countries between $3 to $10, Reuters reports. Serum Institute of India will provide 100 million doses of AstraZeneca‘s vaccine for $3 per dose, while Pfizer is offering 50 million doses at $6.75 apiece. Finally, Johnson & Johnson will offer 120 million doses of its single-shot vaccine at $10 each.
UPDATED: Tuesday, Jan. 19 at 3:17 p.m. ET
A factory upgrade in Puurs, Belgium is putting a temporary squeeze on deliveries of Pfizer and BioNTech‘s shot to Europe, Canada and a few other regions, The Wall Street Journal reports. Unveiled last week, the Puurs expansion should start boosting output in February and is set to “significantly” increase deliveries in the first and second quarter, BioNTech said. Deliveries will return to normal starting next week, the companies added. Six EU countries were quick to hit back, calling the situation “unacceptable” in a letter to the companies, Reuters reports. Story
Pfizer supports President-elect Joe Biden‘s plan to roll out 100 million vaccine doses in his first 100 days in office, CEO Albert Bourla said. Biden on Thursday unveiled a $1.9 trillion plan to combat COVID-19, which includes federally-assisted vaccination centers, mobile clinics, an expanded healthcare workforce and more. As for whether available shot supplies support Biden‘s goal, “It will be a hefty lift, but we have enough to do that,” Rochelle Walensky, Biden‘s pick for CDC chief, told CBS’ Face the Nation.
The World Health Organization’s equitable vaccine distribution scheme Covax—co-led by Gavi, The Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI)—could soon secure doses of Pfizer and BioNTech‘s mRNA shot, senior adviser Bruce Aylward said. Covax aims to start deploying doses to low- and middle-income countries in February.
Pfizer and BioNTech will provide the FDA with a Biologics License Application—needed to snare full approval for their COVID-19 shot—in the first half of 2021, with a view to secure a green light in the second half of the year, the companies told Fox News.
Clinical trials combining AstraZeneca‘s COVID-19 vaccine with Russia’s Sputnik V shot could kick off in early February, Alexei Repik, chairman of the Russian drugmaker R-Pharm, which is on deck to produce both vaccines, told Reuters. Researchers will look to recruit some 100 subjects for the first two phases of the study, which will take place in Azerbaijan, Argentina, Saudi Arabia, the United Arab Emirates, Belarus, Russia and elsewhere.
Brazil’s drug regulator on Sunday cleared AstraZeneca and Sinovac’s shots for emergency use. The Brazilian government aims to launch a national vaccination campaign on Wednesday, though it’s still waiting on doses from AstraZeneca to arrive, Reuters reports. The country has locked down 2 million AZ million doses through the Serum Institute of India, which should arrive this week, the country’s health minister said Sunday.
Cancer vaccine specialist Gritstone Oncology is developing a vaccine against SARS-CoV-2 that could work against other coronaviruses, too. The vaccine leverages Gritstone’s EDGE technology, which uses machine learning to predict antigens presented by tumor cells or virus-infected cells that the immune system can see. The company has snared a grant from the Gates Foundation for preclinical work, while the NIAID is set to conduct a phase 1 trial. Story
Thermo Fisher is laying out up to $550 million to buy handheld test maker Mesa Biotech. Mesa early last year bagged an emergency nod for its rapid, molecular Accula test at point-of-care for COVID-19. It’s also been pegged in the National Institutes of Health’s “Shark Tank”-style COVID-19 diagnostics competition, winning federal funding to help scale up its manufacturing lines. Mesa will receive $450 million cash, plus up to $100 million more for future milestones. The deal is expected to close by the end of March. Story
UPDATED: Tuesday, Jan. 19 at 10:00 a.m. ET
Approvals for Johnson & Johnson and AstraZeneca‘s COVID-19 vaccines are mere “weeks away,” the nation’s top infectious disease expert, Anthony Fauci, told Meet the Press. J&J has said it’s expecting late-stage results on its shot by the end of January. J&J’s shot, which is designed to work at a single dose—unlike Pfizer and Moderna‘s two—could help expedite vaccination efforts in the U.S., health officials figure.
Pfizer and BioNTech are cutting European vaccine deliveries in the next few weeks, thanks to factory modifications—and now Germany’s Bayer wants to to fill in the gaps with supplies of CureVac’s mRNA shot. “We are ready to pull out all the stops for this,” Bayer chief Werner Baumann told German paper Welt am Sonntag. Several EU countries complained Friday that Pfizer and BioNTech would scale back promised deliveries as they work on upgrades at Pfizer‘s plant in Puurs, Belgium.
State epidemiologist Erica Pan, M.D. urged California to temporarily pause distribution of one Moderna vaccine lot after fewer than 10 patients at a San Diego clinic suffered severe allergic reactions requiring medical attention within a day of being vaccinated. The manufacturer, the CDC and the Food and Drug Administration are investigating.
Governor Andrew Cuomo went straight to the source to ask Pfizer to sell vaccine doses directly to New York State. That move would require approval from the Department of Health and Human Services, the drugmaker replied.
Two people have died after receiving COVID-19 vaccines in India, and local shot maker Bharat Biotech on Monday warned people who are immunocompromised or have “any allergies” to avoid its vaccine. Bharat’s shot was recently authorized in “clinical-trial mode,” just one day after authorities pressed the company for more efficacy data. An Indian 52-year-old hospital worker died a day after getting AstraZeneca‘s Covishield shot. Government officials said the man suffered from cardiac arrest, but stressed that his death wasn’t related to the vaccine. A second person who was vaccinated Saturday died Monday, though it remains unclear whether he got Bharat’s or AZ’s vaccine, both of which are authorized in India.
The Subject Expert Committee of India’s Central Drugs Standard Control Organisation is weighing whether to OK phase 1 and 2 clinical trials of Bharat Biotech’s intranasal vaccine candidate. The adenovirus vectored candidate, BBV154, has so far triggered a protective immune response in mice and hamsters. Earlier this month, Bharat’s two-dose intramuscular vaccine was authorized alongside AstraZeneca‘s shot, produced by Serum Institute of India under the name Covishield, in-country.
Mexico is set to receive 200,000 Pfizer vaccine doses Tuesday before shipments are temporarily paused for the next three weeks. The pause supports a United Nations proposal to limit purchases as vaccine shipments make their way to poorer countries. It shouldn’t scupper Mexico’s plans to vaccinate its citizens, President Manuel Lopez Obrador said. The country is currently locking in shot deliveries from China’s CanSino, Russia and AstraZeneca, he said.
Norway won’t change its policy on Pfizer and BioNTech‘s vaccine after reports of deaths among older, frail patients who’d received the shot. As of Jan. 14, 23 deaths potentially linked to the vaccine had been reported by the Norwegian health registry. “It is important to remember that about 45 people die every day in nursing homes in Norway, so it is not a given that this represents any excess mortality or that there is a causal connection,” Camilla Stoltenberg, director of the Norwegian Institute of Public Health, said.
Serum Institute of India (SII) is homing in on a deal to supply the WHO-Gavi equitable vaccine distribution effort Covax with around 300 million to 400 million more vaccine doses, sources told Rediff. The 400-million-dose supply deal would be separate from a previous agreement SII made to supply 100 million doses each of AstraZeneca and Novavax’s shot.
Israel is offering Pfizer weekly updates on its immunization program to help other countries improve their vaccination drives and achieve “herd immunity.” Under the deal, the country is providing epidemiological data like the number of confirmed COVID cases, hospitalizations, deaths, the number of patients on ventilators, plus age and other demographic breakdowns. So far, about a quarter of the country’s citizens have received their first dose.
UPDATED: Friday, Jan. 15 at 1:51 p.m. ET
The Norwegian Medicines Agency says it’s received reports of 23 deaths potentially linked to Pfizer and BioNTech‘s COVID-19 vaccine Comirnaty. It has so far assessed 13 of the reported cases. Common side effects of the mRNA vaccine like fever and nausea may have contributed to the deaths of certain older, frail patients, the agency’s chief physician, Sigurd Hortemo, said in a statement.
A COVID-19 vaccine developed by the Sinopharm subsidiary China National Biotec Group (CNBG) appears safe in children as young as three years, Reuters reported, citing China’s state-run press agency, Xinhua. It wasn’t immediately clear which of CNBG’s two late-stage vaccines was tested in children, though it could be the company’s BBIBP-CorV candidate, Reuters surmised, pointing to a previously disclosed phase 2 trial of that shot in children aged three to 17 years old. Story
Researchers at the University of Cambridge developed a DNA test to catch secondary infections, like pneumonia, that may come about during COVID-19 treatment. Patients on mechanical ventilation often receive anti-inflammatory drugs to ease lung damage, but this can leave them more susceptible to bacteria and fungi in the hospital. Developed in collaboration with Public Health England, the test is designed to identify the infection and suggest the proper antibiotic response. It’s currently being rolled out to healthcare providers via Cambridge’s NHS Foundation Trust. Story
Parexel is joining forces with Signify Health to better understand clinical trial diversity and re-model their studies accordingly. The partnership aims to boost trial access, bring studies into patients’ homes and identify social determinants of health to “facilitate connections among local resources, patients, and caregivers,” the pair said in a release. The issue of clinical trial diversity was thrown into sharp relief last year as the COVID-19 pandemic exposed longstanding healthcare inequities. Story
How do you launch a drug during a pandemic? Technology—plus a rolodex full of established contacts, Incyte CEO Hervé Hoppenot told Fierce Pharma. Incyte navigated the launches of two new cancer meds in 2020—Pemazyre and Monjuvi—thanks to its sales reps’ existing relationships with cancer centers and doctors, who were willing to jump on Zoom to get the skinny, he said. Things are “quite a bit more challenging” for companies without those connections, Hoppenot admitted. Story
UPDATED: Friday, Jan. 15 at 9:33 a.m. ET
Moderna is offering a third dose of its vaccine to patients who were vaccinated twice in the biotech’s phase 1 trial—part of an ongoing study to see whether booster doses are necessary, safe and effective. Moderna is extending the booster to participants six to 12 months after they got their second doses. The company said it may also study a third shot in patients from its late-stage trial, if antibody persistence data warrant it.
President-elect Joe Biden tapped David Kessler, M.D., to take the reins at Operation Warp Speed, The New York Times reports. Kessler was FDA chief during George Bush and Bill Clinton’s presidencies and is co-chair of the Biden transition team’s pandemic task force. He will split top responsibilities with Gen. Gustave Perna, who will keep his role as Warp Speed’s chief operating officer. Kessler will work to speed deliveries of vaccines throughout the country and is also expected to kick off a major antiviral development program, transition officials told NYT.
Meanwhile, President-elect Biden on Thursday asked Congress for about $400 billion in additional pandemic funding to establish a national vaccination program, expand COVID-19 testing and hire on some 100,000 healthcare workers. Biden envisions about $20 billion going toward the addition of an unspecified number of vaccination sites, including mobile ones. He wants to plug another $50 billion into expanded testing efforts, as well as hire on a suite of public health staffers and boost efforts to track emerging virus variants, too.
When India launches its mass vaccination campaign Saturday, the government will approach AstraZeneca and Bharat Biotech’s shots “equally,” and people won’t have a say in which vaccine they get, Vinod Paul, who heads a government panel on vaccine strategy, told Reuters. Bharat’s shot Covaxin was recently authorized in “clinical-trial mode,” just one day after authorities pressed the company for more efficacy data. Many health experts have since challenged Covaxin’s go-ahead. Meanwhile, late-stage data on the vaccine are expected in March.
Speaking of AstraZeneca, the Serum Institute of India (SII) expects WHO to issue an emergency nod for the British drugmaker’s shot “in the next week or two,” SII chief Adar Poonawalla said at the Reuters Next conference. SII hopes to start supplying shots to the agency’s equitable vaccine distribution effort, Covax, by the end of January, he said. WHO late last year listed Pfizer and BioNTech‘s mRNA shot for emergency use in a bid to hasten vaccination efforts in the developing world.
UPDATED: Thursday, Jan. 14 at 3:25 p.m. ET
Moderna linked up with Uber to boost shot confidence and make it easier for people to get vaccinated, too. It’s still early-stage stuff, but initial ideas include promoting vaccine safety through in-app messages on the Uber network, as well as folding rides into the vaccine scheduling process. The goal is to provide widespread access and improve outreach to underserved populations and people who are vaccine-hesitant, Michael Mullette, Moderna’s VP of commercial operations in North America, said. Story
A slate of tech companies and health organizations—including Microsoft, Oracle, Salesforce, Cerner and the Mayo Clinic—have partnered on the Vaccination Credential Initiative, aiming to establish a standard for digital vaccination records. The goal is to eventually provide people with an “encrypted digital copy of their immunization credentials” on their smartphones, or a printed QR code for people without a device.
As certain hospital and nursing home staffers refuse vaccines, employers are adopting unusual measures to sweeten the offer—like cash, extra time off and Waffle House gift cards—or threatening to fire their workers altogether, The New York Times reports. Long-term care chains Juniper Communities and Atria Senior Living are making the shot non-negotiable if employees want to keep their jobs, for instance. Meanwhile, critics told NYT it’s unethical to pressure low-paid workers into getting the vaccine.
Florida’s so-called “vaccine tourism,” is taking heat, The Wall Street Journal reports. The state has made the vaccine available to anyone age 65 and older, including nonresidents, drumming up interest from people in places like Canada and Latin America eager to fly over for a quick shot. The move has frustrated academic experts, politicians and residents across the Sunshine State. Meanwhile, Gov. Ron DeSantis said he wasn’t opposed to giving the shot to those who live in Florida part-time, but added that the state’s “discouraging people to come to Florida just to get a vaccine.”
The wildly divergent efficacy figures for Sinovac’s shot, CoronaVac—which Brazilian scientists most recently pegged at a little over 50%—could put China’s plans for global health diplomacy at risk, the NYT reports. Countries that bought the shot may question its efficacy, which could lead to political fallout in places like Brazil, where the prospect of importing CoronaVac has already been fraught. Meanwhile, the piecemeal release of data “just reinforced the narrative that this vaccine is not good,” Brazilian-American epidemiologist Denise Garrett told NYT.
Twitter on Thursday briefly restricted the official account of Russia’s Sputnik V vaccine, prompting the Russian Direct Investment Fund to put out a call to action for its followers to demand restored access. Turns out, that wasn’t necessary. “This account was temporarily locked in error by an automated spam filter. This action has been reversed and the account is now fully operational,” Twitter said in a statement. The temporary shutdown may be tied to “a possible security breach from Virginia, USA,” the Sputnik V account said.
UPDATED: Thursday, Jan. 14 at 9:45 a.m. ET
Johnson & Johnson’s single dose COVID-19 vaccine seems to trigger a safe and effective immune response in people young and old, phase 1/2 data published in the New England Journal of Medicine showed. Ninety percent of volunteers developed neutralizing antibodies by day 29, while all volunteers had detectable antibodies by day 57. Plus, patients’ immune responses lasted all 71 days of the trial. Fever, headache, fatigue, muscle aches and injection site pain comprised the most common side effects.
Initial Johnson & Johnson vaccine shipments could arrive in Europe by April 1, a European Union official told Reuters. The European Medicines Agency has been conducting a rolling review of J&J’s shot since the start of December. Earlier Wednesday, EU lawmaker Peter Liese told the news outlet that J&J would submit an application for approval in February, citing Health Commissioner Stella Kyriakides.
Alexion is halting enrollment of its phase 3 Ultomiris trial in severe COVID-19 patients requiring mechanical ventilation. The move comes on the heels of an independent data analysis, which found Ultomiris plus best supportive care didn’t meaningfully boost survival at day 29 versus supportive care alone. The study will continue for patients already enrolled, Alexion said. Story
The industry can expect COVID-19 work to be “recurring and long-lasting,” Operation Warp Speed chief Moncef Slaoui said Wednesday at the J.P. Morgan Healthcare Conference. While the general public may be holding out hope that the pandemic will simply disappear, “we cannot forget,” Slaoui warned. “We forgot with Ebola. We forgot with Zika.”
Scientists at The Ohio State University Wexner Medical Center and College of Medicine have ID’d a new variant of the coronavirus that bears a mutation identical to the variant from the UK.—though it likely cropped up in a version of the virus already present in the U.S., they said. Meanwhile, the researchers reported another U.S. variant with three gene mutations not previously seen together in SARS-CoV2. At this point, researchers say they have no evidence to suggest the new variants might affect vaccine efficacy.
President-elect Joe Biden on Wednesday evening is expected to blueprint plans for trillions of dollars of government spending to tackle COVID-19 and its effects on the economy. Part of that package will fuel vaccine development, testing and contact tracing efforts, Brian Deese, the soon-to-be director of the National Economic Council, said Wednesday at the Reuters Next conference.
UPDATED: Wednesday, Jan. 13 at 3:30 p.m. ET
Under its $1 billion Operation Warp Speed (OWS) contract, Johnson & Johnson was originally set to provide 12 million vaccine doses by the end of February and 100 million by the end of June, but federal officials have now been informed the company is behind on its production timeline, sources told The New York Times. OWS chief Moncef Slaoui last week said the company would be able to deliver doses in the “single-digit” millions by February’s end as J&J works to boost those numbers over the following months, the NYT reports. Story
Sinovac’s vaccine was just 50.38% effective in a Brazilian phase 3, the Butantan Institute—which ran the trial—and the government of Sao Paulo said Tuesday. That’s well below the 78% success rate Butantan reported last week, which it has now linked to efficacy against mild COVID cases. Meanwhile, it reported the shot was 100% effective against moderate and severe cases, but just 50.38% effective overall. Elsewhere, early phase 3 data from Indonesia placed efficacy at 65.3%, while Turkey said the shot was 91.25% effective.
Armed with an educational grant from the Johnson & Johnson Institute, medical education video game developer Level Ex has created new pandemic-specific levels for its Airway Ex, Pulm Ex and Cardio Ex mobile games. Similar to a flight simulator for pilots, Level Ex’s games place players in a digital emergency room, facing patients who may or may not be infected with COVID-19. Players must determine whether the virtual patient is infected and, if so, decide how to safely deal with them to minimize spread. Story
Researchers from the University of Bonn, the Karolinska Institute and Scripps Research Institute designed a COVID-19 drug based on “nanobodies,” the tiny antibodies produced by camelids. By fusing two nanobodies picked from a llama and an alpaca immunized with the virus, the researchers synthesized nanobodies able to simultaneously attack multiple sites of the virus’s spike protein and fight mutated variants, too, a study published in Science showed. A University of Bonn spinoff, Disclosure Therapeutics, plans to push two lead candidates into the clinic this year. Story
Celltrion’s experimental antibody helped mild-to-moderate COVID-19 patients in a phase 2/3 trial. The 40 mg/kg dose—the lower of two Celltrion is testing—reduced progression to severe disease by 54% versus placebo at day 28, while reduction was 68% in a subgroup of moderate COVID patients aged 50 years and older. Patients on the low dose recovered in 5.4 days, compared to 8.8 days in the control group, with the difference even larger in certain subgroups. Meanwhile, viral load fell significantly versus placebo at Day 7. Story
Pfizer and BioNTech were able to raise their projected 2021 vaccine output to 2 billion doses thanks to some “very out of the box” manufacturing,” Pfizer chief Albert Bourla said Tuesday. The company has launched a slate of initiatives, including changing the way it works with partners on raw materials, reimagining its operational flow to boost capacity, designing new equipment and more, he said. Story
Don’t discount CureVac’s role as a major vaccine player just yet, Marianne De Backer, head of business development at Bayer—which recently penned a vaccine pact with CureVac—said Wednesday at the J.P. Morgan Healthcare Conference. “[We] will need between 12 (billion) and 14 billion doses to get a full handle on the pandemic,” she said, suggesting every company in the vaccine race should “continue to put all the effort in to curb this pandemic.” Story
It’s still too early to say when AstraZeneca might turn a profit on its vaccine, Ruud Dobber, EVP and biopharma president at the company, said in a Fierce JPM Week interview. “Let’s first deliver all the doses, let’s make sure people are getting vaccinated, and then we will decide at a certain stage when we are going to commercialize the vaccine,” he said. AZ has said it won’t profit off the vaccine during the pandemic, though a report emerged in October that the drugmaker might be ready to declare the pandemic over as soon as July. Story
UPDATED: Wednesday, Jan. 13 at 9:20 a.m. ET
The U.S. agreed to buy all doses of Regeneron’s antibody cocktail delivered by June 30, amounting to upward of 1.25 million, the company said. The deal brings the government’s total potential order to over 1.5 million doses. Uptake of the treatment has been underwhelming, George Yancopoulos, M.D., Ph.D., Regeneron’s R&D chief, said at this week’s J.P. Morgan healthcare conference—a problem the company said it could remedy by working more closely with the U.S. government.
Operation Warp Speed chief Moncef Slaoui has resigned at the request of President-elect Joe Biden‘s transition team. Slaoui will stick around for the next 30 days to ease the switch, two people close to the matter told CNBC. His role will likely be diminished once Biden takes office on Jan. 20, the sources added.
Pfizer is working with BioNTech to ratchet up its 2021 vaccine production goal to 2 billion doses, CEO Albert Bourla, Ph.D., reiterated Tuesday. Pfizer will also implement a label change to include six doses in each vial instead of five—plus, it’s rolling out a new syringe that reduces the chances of liquid becoming stuck in the needle.
Some Australian scientists think the country should delay its immunization drive with AstraZeneca‘s vaccine, citing potential efficacy issues, Reuters reports. “The question is really whether [AstraZeneca‘s vaccine] is able to provide herd immunity,” Stephen Turner, president of the Australian and New Zealand Society for Immunology, told the news service. AZ’s shot boasted 62% efficacy in phase 3, well below the 90%-plus success rates of Pfizer and Moderna‘s vaccines.
Despite those calls, Australia’s CSL remains committed to production of the 50 million AstraZeneca doses it agreed to churn out last year—even as investors call for CSL to break into the mRNA space, The Sydney Morning Herald reports. A CSL spokeswoman told the news outlet that the first locally produced doses would be available in the second quarter of the year, subject to regulatory approval. The company said it could look to mRNA in the future but likely couldn’t produce mRNA vaccines in time for this pandemic.
China’s Sinovac could double annual capacity for its pandemic shot, CoronaVac, to 1 billion doses as early as next month, the group’s chairman, Yin Weidong, said Wednesday. Sinovac’s existing production line boasts capacity for 500 million doses per year, while another line with the same capacity could come online by February, Yin said.
UPDATED: Tuesday, Jan. 12 at 3:13 p.m. ET
Some COVID-19-related documents and data breached in a December cyberattack on the European Medicines Agency (EMA) have surfaced online, the regulator said Tuesday. The EMA didn’t disclose which documents or data were leaked, adding that law enforcement was on the case. Pfizer and BioNTech in December said documents related to their COVID-19 vaccine, Comirnaty, had been accessed in the attack.
French shot developer Valneva is in “advanced” talks with the European Commission to supply Europe with up to 60 million doses of its inactivated vaccine candidate, the company said. The shot entered phase 1/2 studies in December, with initial safety and immunogenicity data expected in April, Valneva said. Meanwhile, the company in September agreed to supply the UK. with up to 190 million doses.
A new coronavirus variant, similar to those identified in South Africa and the UK., has cropped up in Japan, the country’s National Institute of Infectious Diseases (NIID) said. The variant was found in four passengers traveling from Brazil, one of whom was asymptomatic upon arrival before he was later hospitalized, Japan’s Ministry of Health added. The NIID has alerted the World Health Organization and said it is investigating whether the variant could trigger more severe disease.
Uptake of Regeneron’s antibody cocktail needs to improve, R&D chief George Yancopoulos, M.D., Ph.D., said Monday at the annual J.P. Morgan healthcare conference. To overcome potential treatment barriers—Regeneron’s cocktail requires a prescription and must be infused—the company plans to work “much more closely” with the government to effectively deliver its cocktail to patients, he said. Plus, the therapy should stand up against emerging virus variants, since “it reduces the likelihood that a single variant can become resistant to both antibodies in the cocktail,” CEO Len Schleifer, M.D., Ph.D., said. Story
For many drugmakers, changes made during the pandemic are here to stay. Eli Lilly, for instance, plans to continue leveraging virtual trials that feature remote patient monitoring and digital interactions with trial sites, CEO David Ricks said Tuesday. Meanwhile, the advent of remote work has inspired Moderna to weigh how it leverages talent regardless of geography, the company’s chief, Stéphane Bancel, said. Story
The first wave of COVID-19 vaccines wont be enough to quell the pandemic, Swati Gupta, Ph.D., an executive with IAVI, said on a Fierce JPM Week panel. While those early launches will help end the “acute” phase of the pandemic, COVID-19 will likely become endemic, so “we also need to plan for longer-term management of the disease.” Others, like Valneva CEO Thomas Lingelbach, are confident there will be demand for follow-up vaccines. Those shots could offer efficacy at a single dose, prove easier to scale up or be better-suited to refrigerated storage, Gupta added. Story
UPDATED: Tuesday, Jan. 12 at 1:12 p.m. ET
The Trump administration is switching up its vaccine rollout, Axios first reported. First, the administration aims to promptly release the majority of shots on tap, rather than holding them back for second doses, Department of Health and Human Services Secretary Alex Azar told ABC’s “Good Morning America.” It’s also calling on states to give the vaccine to everyone 65 and older, plus those with underlying health conditions, he said. President-elect Joe Biden last week said he wanted to release most available doses to get them out to the public faster. Meanwhile, Azar is set to share further details at a midday press conference.
UPDATED: Tuesday, Jan. 12 at 11:26 a.m. ET
GlaxoSmithKline and Vir Biotechnology will run a National Health Service-backed trial assessing Vir’s antibody hopeful, VIR-7832, in early COVID-19. The so-called Agile trial is due to kick off in the first quarter of 2021 and will take place at multiple sites in the UK., the companies said. Meanwhile, the partners have another Vir antibody, VIR-7831, currently in two phase 3 studies. The new trial comes as experts are emphasizing the need for additional COVID-19 therapeutics.
AstraZeneca‘s vaccine is up for review this month in Europe, the European Medicines Agency said. The regulator on Tuesday said it received an application from AstraZeneca and could make an authorization decision as early as Jan. 29. The EU has locked in an order for up to 400 million AstraZeneca doses and expects to receive initial deliveries two weeks after authorization.
Los Angeles County is pulling Curative’s oral swab COVID-19 test from its mobile testing sites after the FDA warned that the startup’s diagnostic carries a risk of false results—and in particular, false negatives, local outlet KTLA reports. Asymptomatic patients are especially likely to receive incorrect results, the FDA added. Curative tests at 14 sites operated by the city will remain unaffected by the county’s decision.
Japan’s Chugai Pharmaceutical saw its shares surge Tuesday on the heels of a UK.-funded study showing rheumatoid arthritis meds Kevzara and Actemra could reduce the risk of death and hustle COVID-19 patients out of intensive care units faster. Chugai co-developed Actemra, also known as tocilizumab, with Roche, while Sanofi and Regeneron are working together on Kevzara, also known as sarilumab.
Elsewhere in L.A., officials are converting Dodger Stadium from a testing site to a vaccination center, hoping to eventually immunize 12,000 people a day, the Los Angeles Times reports. Until Monday, Dodger Stadium was the largest testing site in the U.S. and had administered more than 1 million tests since May.
The Biomedical Advanced Research and Development Authority folded Albany Molecular Research’s (AMRI’s) Albuquerque, New Mexico, facility into its CDMO network. AMRI’s Albuquerque site houses a large fill-finish facility that is already supporting COVID-19 vaccine production, the company said.
UPDATED: Monday, Jan. 11 at 3:05 p.m. ET
Novavax tapped contract manufacturer Baxter BioPharma Solutions to support commercial-scale production of its vaccine hopeful, NVX-CoV2373, at the CMO’s facility in Halle, Germany. The move is intended to boost availability of the shot, still in phase-3 studies, across Europe and the UK., the partners said in a release.
Moderna is kicking off deliveries of its mRNA vaccine to European Union and European Economic Area member states on Monday, a spokesperson told Fierce Pharma. All shipments will be handled by the Switzerland-based transport and logistics firm Kuehne+Nagel through its centralized pharma hub in Europe.
Merck KGaA snapped up German mRNA manufacturer AmpTec to bolster development and production for customers using the platform to make diagnostics, therapeutics and vaccines, including those for COVID-19. With mRNA technology on the rise, Merck says it’s plotting related scale-ups at AmpTec’s existing site in Hamburg, Germany, plus its own home base in Darmstadt. Story
As the scramble to repurpose drugs against COVID-19 tapers off, “I think what we’re seeing is the emergence of real customized drugs that are highly focused on SARS-CoV-2,” Ann Leen, Ph.D, chief scientist at AlloVir—developing off-the-shelf T-cell therapies to combat viruses—said during a Fierce JPM Week panel. As experts’ understanding of COVID-19 evolves, it’s clear there won’t be a “silver bullet,” Wendy Holman, CEO of Ridgeback Biotherapeutics, said. “It’s important to have multiple shots on goal and potentially, combination therapy.” Story
Select Publix pharmacies in Florida will start deploying COVID-19 vaccines, Gov. Ron DeSantis said—and all available appointments have already been booked, local outlet ClickOrlando reports. Each site plans to vaccinate around 120 people per day, the supermarket chain said. Publix is also supporting vaccination drives in Georgia, Alabama, Tennessee, South Carolina, North Carolina and Virginia.
President-elect Joe Biden got his second dose of Pfizer‘s vaccine on camera Monday. This marks Biden‘s second televised vaccination—part of a bid to boost confidence in the shot. Vice President-elect Kamala Harris was also taped when she received her first dose of Moderna‘s shot in December, one week after Biden‘s initial injection. Biden has pledged to roll out 100 million COVID-19 shots during his first hundred days in office and recently suggested the U.S. release nearly all doses on hand to hasten distribution efforts.
Synairgen’s inhaled form of interferon beta-1a raised levels of a short form of ACE2 that doesn’t allow the COVID-19 virus to enter cells and may also have a protective effect, researchers at the University of Southampton found. Last summer, Synairgen showed that its interferon drug lowered risk of progression to severe COVID-19 in a 101-subject trial, but there was a caveat: Interferon is known to increase levels of the cell surface protein ACE2, which serves as the entry point for the virus that causes COVID-19. Story
NeuroRx and Relief Therapeutics’ coronavirus treatment hopeful Zyesami has been pegged for inclusion in the I-SPY COVID-19 Trial. Sponsored by San Francisco’s Quantum Leap, the I-SPY platform study is assessing multiple drugs in patients hospitalized with severe COVID-19. Zyasemi is also being studied in two U.S. phase 2b/3 trials in COVID-19 respiratory deficiency, both as an inhaled and intravenous option.
Russia wants to expedite its immunization program by potentially halving the two-dose regimen of its Sputnik V vaccine, The New York Times reports. While Russia’s shot currently leverages two types of genetically modified human adenoviruses, the single-dose approach would see only one type of the cold virus administered in each shot, Sputnik V’s developer, the Gamaleya Institute, said.
UPDATED: Monday, Jan. 11 at 9:27 a.m. ET
Fujifilm Diosynth and Texas A&M’s Center for Innovation in Advanced Development & Manufacturing (CIADM) kicked off production of two vaccine candidates at CIADM’s Flexible Biomanufacturing Facility in College Station, Texas. Fujifilm has been tapped to crank out bulk drug substance for Novavax’s candidate, NVX‑CoV2373, which kicked off phase 3 testing the U.S. and Mexico in December. The company is also manufacturing the shot at commercial scale at its Morrisville, North Carolina, plant.
BioNTech ratcheted up its vaccine production forecast at this year’s virtual J.P. Morgan healthcare conference. The company now has its sights set on 2 billion doses by year-end, up from an original 1.3 billion-dose goal. Meanwhile, it’s looking to boost supply capacity by introducing a new six-dose vial, alongside plans to establish new sites, suppliers and CMO pacts.
It’s time for the U.S. to “hit the reset” on its vaccine rollout strategy, ex-FDA chief Scott Gottlieb, M.D., told CBS News’ “Face the Nation” Sunday. With some 40 million doses available, the government should adopt an “all-of-the-above approach” to push shots out through different channels like “big-box stores” and the federal sites President-elect Joe Biden has talked about setting up. So far, only about 6.7 million Americans have received the first of two necessary doses, according to the CDC.
Meanwhile, front-line healthcare workers at greater Manchester hospitals in the UK. will have to wait 11 weeks before they can get their second dose of Pfizer and BioNTech‘s vaccine, Manchester Evening News reports. The British government last month unveiled plans to delay patients’ second shots as the country prioritizes delivery of initial doses. Pfizer itself has cautioned against the move, warning that available data do not support a longer lag time between doses. The recommended schedule is 21 days after the first dose.
Gregory Michael, a 56-year-old doctor from South Florida, died two weeks after taking Pfizer and BioNTech‘s COVID-19 vaccine. A CDC spokesman confirmed to local news outlet South Florida Sun Sentinel that it’s investigating one death where a vaccine may be involved, but didn’t confirm whether it was specifically reviewing Michael’s case. Pfizer is running its own investigation, though it doesn’t believe there is any direct connection between the death and its vaccine, a spokesperson told the Sun Sentinel.
The Indian government is in talks with the Serum Institute of India (SII) to lower the price of AstraZeneca‘s vaccine, sources close to the matter told The Economic Times. While the country’s drug regulator has authorized shots from AZ and local developer Bharat Biotech, it hasn’t locked down firm orders with either company, ET wrote. SII chief Adar Poonawalla in November said the shot would cost around ₹1,000 ($13.55) per dose on the private market in India and around ₹250 ($3.40) per dose for the government.
Pfizer and BioNTech‘s vaccine will only be available in “major cities” in the Philippines, thanks to a lack of cold chain capability in the country, a presidential spokesperson said. The country recently locked in an order for 30 million doses of Novavax’s vaccine through the Serum Institute of India, the spokesperson added. Plus, the country is in talks with Moderna, AstraZeneca, Johnson & Johnson, Sinovac and Russia’s Gamaleya Institute.
UPDATED: Friday, Jan. 8 at 3:10 p.m. ET
With the U.S.’ shot rollout lagging, President-elect Joe Biden wants to release nearly all available vaccine doses, his transition team said Friday. “[Biden] supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” a spokesman for the transition team said. One potential hurdle? Releasing those doses all at once could make it harder for people to receive their second shot on time. Both Moderna and Pfizer‘s vaccines call for two doses at specific intervals.
Labcorp is teaming up with the CDC to conduct a large-scale genomic study tracking new mutations in the coronavirus. The agency plans to collect random samples from around the U.S., providing a baseline that should allow national and state-level surveillance programs to catch emerging cases. With Labcorp’s facilities on deck, the CDC says it aims to more than double the number of genomic samples sequenced per week. Story
Moderna named industry vet Corinne Le Goff chief commercial officer as the drugmaker embarks on its first-ever product launch—which just so happens to be the second COVID-19 vaccine to market in the U.S. Le Goff joins from Amgen, where she was most recently senior VP and president of the company’s U.S. business. Aside from its pandemic shot launch, Moderna is gearing up for a phase 3 study of its mRNA-based cytomegalovirus vaccine. Story
Pfizer has agreed to boost vaccine deliveries to Israel in exchange for data on the country’s immunization program, Prime Minister Benjamin Netanyahu said Thursday. More than 1.7 million Israelis have already received their first dose, and the country has sketched out the goal to be able to vaccinate all citizens over the age of 16 by the end of March. While Israel’s second Pfizer shipment was originally scheduled to arrive in February, that delivery is now expected Sunday. Plus, Pfizer has agreed to provide the country with millions more doses, Netanyahu said.
It’s fine if priority vaccination groups overlap, the CDC said Friday, clarifying guidance that many states have already implemented as they hustle to get shots out to the public. Healthcare workers and nursing home residents should be first in line, followed by essential workers and people over the age of 75, the agency has said. The CDC’s website is now updated to show that the various priority groups—1A, 1B and 1C—could intersect.
Meanwhile, healthcare providers in the UK., plus some parts of Florida, Tennessee and Texas, are using the online ticketing service Eventbrite to schedule vaccine appointments, The New York Times reports. It’s far from a perfect system, though: Scams for bogus vaccination slots have already been reported in Florida, while some have cited the need for a computer and a speedy internet connection to book an appointment as a potential barrier to access.
UPDATED: Friday, Jan. 8 at 9:17 p.m. ET
The European Commission floated a deal to snag an extra 200 million doses of Pfizer and BioNTech‘s vaccine, with the option to later purchase 100 million more. Building on a previous deal for up to 300 million doses of the partners’ shot, the expanded order would allow the bloc access to some 600 million doses. Deliveries of the newly secured product would begin in the year’s second quarter, the commission said.
The UK. authorized Moderna‘s mRNA vaccine Friday, adding a third shot to its pandemic arsenal. The country also locked down an additional 10 million Moderna doses, bringing its total order to 17 million. Deliveries are pegged to begin in the spring. So far, roughly 1.5 million people in Britain have received at least one shot, Bloomberg reports.
Pfizer and BioNTech‘s vaccine seems to work against a key mutation in variants of the novel coronavirus found in South Africa and the UK., a lab study showed. Blood collected from 20 patients who received the shot in Pfizer‘s phase 3 successfully neutralized the so-called N501Y mutation, located in the receptor binding site of the spike protein. The partners have now shown their vaccine works against 16 different mutations of the virus. Story
The World Health Organization (WHO) is reviewing shots from AstraZeneca and China for a possible emergency listing, Kate O’Brien, the agency’s immunization director, said Thursday. The WHO is also “in discussions and beginning processes with other vaccines,” she added. The agency on Dec. 31 listed Pfizer and BioNTech‘s vaccine for emergency use.
Australia inked a deal for 51 million doses of Novavax’s late-stage vaccine, with the option to buy up to 10 million more doses, the company said Thursday. Shipments are expected to kick off in mid-2021. Novavax launched a U.S. phase 3 study in December after weathering multiple manufacturing delays.
South Africa is in “advanced” talks with Johnson & Johnson to lock down vaccine supplies, the country’s health ministry said Thursday. Local manufacturer Aspen Pharmacare aims to kick off production of J&J’s shot in late March or early April, but those Aspen doses are earmarked for export. The country is set to receive 1.5 million doses through the Serum Institute of India this month and next, which it will use to vaccinate healthcare workers.
Turkish drugmaker Abdi Ibrahim got the OK from the country’s health ministry to manufacture and fill vials of inactivated vaccines, plus mRNA vaccines, against COVID-19, state-run news outlet Anadolu Agency reported. The company has capacity for 20 million doses, Nezih Barut, chairman of Abdi Ibrahim, told Anadolu.
UPDATED: Thursday, Jan. 7 at 3:10 p.m. ET
mRNA specialist CureVac tapped German compatriot Bayer to support clinical development, manufacturing, regulatory affairs and marketing on its late-stage vaccine hopeful, CVnCOV. With their forces combined, the partners aim to crank out “hundreds of millions” of doses once the shot is approved. No financial details were given. CureVac will be on deck in the EU and a few other markets, while Bayer holds options to be the rights owner in most ex-U.S. territories. Story
Roche’s Actemra (tocilizumab) and Sanofi’s Kevzara (sarilumab) reduced death rates by 8.5% in patients hospitalized with severe COVID-19, a British study showed. The REMAP-CAP trial, still awaiting peer review, enrolled some 800 subjects. Patients receiving either Kevzara or Actemra had a mortality rate of 27.3%, compared to 35.8% in the control arm. On average, patients treated with the rheumatoid arthritis meds were also discharged from intensive care units around seven to 10 days earlier than those in the control group. The UK. plans to start using the drugs immediately. Story
South Africa’s Aspen Pharmacare could start producing doses of Johnson & Johnson’s vaccine in late March or early April, if approvals are in place, Stavros Nicolaou, group senior executive for strategic trade at Aspen, told Reuters. The company is waiting on a technology transfer and currently has capacity for up to 300 million doses. All shots produced by Aspen will be exported and folded into J&J’s global supply, Nicolaou said.
Peru locked in the delivery of 1 million Sinopharm vaccine doses this month—part of a larger deal for 38 million doses from the Chinese firm, President Francisco Sagasti said Wednesday. Peru has also closed a deal for 14 million AstraZeneca doses, though shipments aren’t expected to begin until September, Sagasti said.
Sinovac’s shot CoronaVac proved 78% effective in phase 3, Brazil’s Butantan Institute said. Among more than 12,000 healthcare workers enrolled in the trial, no one developed severe cases of COVID-19, the São Paulo-based research center said. Turkey unveiled interim phase 3 data in December showing the vaccine was 91.5% effective. Indonesia is also running a late-stage study of the vaccine but has yet to issue results. Story
William Hanage, Ph.D., associate professor of epidemiology at the Harvard T.H. Chan School of Public Health, is trying to break down two coronavirus variants at the top of everyone’s mind:
As millions of COVID-19 vaccines start rolling out, drugmakers of all kinds should brace for a wave of side effect reports and lawsuits. “Unprecedented” development timelines, emergency use authorizations and media scrutiny will likely drive high incidences of vaccine side effect reports, Torrey Cope, a partner at law firm Sidley Austin, told Fierce Pharma. Meanwhile, vulnerable people set to receive the first vaccines are likely on multiple medications, and companies who make those drugs can expect new reports, too, another partner at the firm said. Story
UPDATED: Thursday, Jan. 7 at 9:12 a.m. ET
Moderna‘s mRNA shot could provide years of protection against COVID-19, though more data are needed to support that claim, CEO Stéphane Bancel said. Concerns from early last year that a shot might only work for a few months are “out of the window,” he said. “The antibody decay generated by the vaccine in humans goes down very slowly … We believe there will be protection potentially for a couple of years.”
Johnson & Johnson’s single-dose vaccine could snare UK. approval within weeks, local scientists and government officials told The Telegraph. Britain has purchased 30 million doses of the vaccine, developed by J&J’s Janssen unit, with the option to purchase another 22 million doses. Meanwhile, UK. Vaccine Taskforce adviser Sir John Bell said he was hopeful J&J supplies could reach the country in time for British vaccination rates to pick up by mid-February.
States need to intensify their vaccine rollouts, and any extra supplies should be used to swiftly vaccinate the elderly or people with underlying health conditions, Department of Health and Human Services Secretary Alex Azar said at a media briefing Tuesday. “We cannot let perfection be the enemy of good,” he said. “Prioritized recommendations are simply recommendations, they should never stand in the way of getting shots in the arms.”
Meanwhile, the UK.’s vaccine rollout is lagging, thanks to limited supply. Now, the government is working with both Pfizer and AstraZeneca to ramp up deliveries, health minister Matt Hancock said. “The manufacturers are doing a brilliant job, and they’re delivering to the schedule that’s agreed, but that schedule is the amount of vaccine that we have … [We] expect to see that amount of vaccine being delivered going up.”
India’s Bharat Biotech has recruited 25,800 volunteers for its late-stage vaccine trial, the company said Thursday. Bharat’s shot, dubbed Covaxin, bagged an emergency use authorization in India Sunday, just seven weeks after starting a phase 3 study. Krishna Ella, chairman of Bharat, recently defended the company’s approval, pointing to a government notification from 2019 that says “good quality immunogenicity data” from phase 1 and 2 trials can be used to win an emergency license.
UPDATED: Wednesday, Jan. 6 at 3:06 p.m. ET
AstraZeneca‘s vaccine now boasts emergency nods in India, Argentina, Mexico, the Dominican Republic, El Salvador and Morocco, the British pharma said Wednesday. The shot’s approval in India, where AZ has teamed up with Serum Institute of India to crank out 1 billion doses for low- and middle-income nations, is an important step toward delivering the vaccine to millions of people worldwide, AZ chief Pascal Soriot said.
Meanwhile, India’s drug regulator has blocked Serum Institute of India (SSI) from exporting doses of the AstraZeneca shot for several months as the country prioritizes vaccinating its own vulnerable populations first, company CEO Adar Poonawalla told the Associated Press. Exports to the WHO’s Covax distribution initiative won’t start until March or April, though SII is working to sign a larger agreement with Covax for 300 million to 400 million doses, he said. SII has so far pledged 200 million doses to the distribution effort, split between AZ and Novavax’s shots.
New York will start fining hospitals that fail to dispense their allocated vaccine doses within a week of receiving supplies, Gov. Andrew Cuomo said Monday. What’s more, the state will also bar those hospitals from receiving future doses. Florida, meanwhile, is allocating doses to hospitals that dispense them quickest, while sites that fail to push the vaccine out fast enough will have their supplies shipped to hastier locations, Gov. Ron DeSantis said.
The U.S. could soon administer at least 1 million COVID-19 vaccines per day, NIAID director Anthony Fauci told the Associated Press. After a slow start, U.S. vaccination efforts are ramping up, reaching some half a million shots a day, he said, adding that President-elect Joe Biden‘s bid to hit 100 million vaccinations during his first hundred days in office was an achievable goal. “Any time you start a big program, there’s always glitches. I think the glitches have been worked out,” Fauci said.
The University of California, San Diego, is using sidewalk vending machines to dispense self-administered COVID-19 tests to students and staff, the La Jolla Light reports. After a nose swab is performed, samples are sealed and returned to drop boxes around campus for analysis by the university’s own EXCITE laboratory. Results are typically returned within 12 to 24 hours. The school currently requires all students on campus to be tested weekly, regardless of symptoms. Story
Color, which bagged a slate of FDA emergency nods for COVID-19 testing and self-sampling kits last year, raised $167 million in a series D funding round as it looks to scale up and expand into digital vaccine logistics. Color’s software platform is used to manage California’s COVID-19 testing efforts, and the company also works with diagnostics maker PerkinElmer to process up to 150,000 samples per day. Looking ahead, Color aims to launch vaccine delivery systems through its established testing networks. Story
UPDATED: Wednesday, Jan. 6 at 9:38 a.m. ET
A South African variant of the novel coronavirus appears to “obviate” certain countermeasures like antibody drugs, former FDA Commissioner Scott Gottlieb, M.D., told CNBC. The variant, which has cropped up in South Africa and Brazil, seems to partially escape prior immunity, which could make recovered patients’ own antibodies and currently approved antibody therapies less effective, Gottlieb warned. “Now, the vaccine can become a backstop against these variants really getting more of a foothold here in the United States, but we need to quicken the pace of vaccination,” he said.
The European Medicines Agency gave Moderna‘s vaccine a thumbs-up, recommending its authorization for people ages 18 and older. The agency’s human medicines committee (CHMP) based its recommendation on phase 3 data showing Moderna‘s shot was 94.1% effective. Once the European Commission rubber-stamps the EMA’s approval, Moderna‘s vaccine will join Pfizer and BioNTech‘s as the second authorized in the EU.
Moderna and the National Institutes of Health are determining whether supplies of the company’s vaccine could be doubled by halving the dose, The New York Times reports. Warp Speed chief Moncef Slaoui, M.D., on Monday said people who received two 50-mcg doses of Moderna‘s shot, compared to the standard 100-mcg regimen, showed an “identical immune response,” referring to data from an early phase 2 study. To change the dosing, Moderna will need to look back at its phase 2 or run a new study.
The UK. should administer second doses of Pfizer and BioNTech‘s vaccine within 21 to 28 days or, in exceptional circumstances, within six weeks, the World Health Organization (WHO) said Tuesday. The UK.’s Joint Committee on Vaccination and Immunisation had recommended patients get their second shot within three to 12 weeks to stretch initial supplies. “[It] is important to note that there is very little data from the trials that underpin this type of recommendation,” one WHO expert said.
Some 3.5 million AstraZeneca vaccine doses are awaiting approval from the UK.’s Medicines and Healthcare products Regulatory Agency (MHRA), Sky News reports. So far, only 530,000 AZ doses out of an initial order for 4 million have been cleared for use through batch testing. The MHRA is working in parallel with AstraZeneca‘s own batch-testing process to speed up deliveries.
India’s authorization of Bharat Biotech’s vaccine is taking more heat. The Indian drug regulator’s subject expert committee actually requested more efficacy data just one day before apparently reversing its stance to issue an OK, documents show. Bharat’s vaccine, Covaxin, is still in phase 3 testing and was approved “in clinical trial mode”—unconventional language that’s left some experts perplexed.
U.S. Rep. Kevin Brady, R-Texas, said Tuesday that he’d tested positive for COVID-19 after receiving an initial dose of Pfizer‘s vaccine. “As recommended, I received a first dose of the Pfizer vaccine Dec 18 & also recently tested negative for Covid on New Years Day. Begin treatment tomorrow,” Brady tweeted.
On Sunday, the Transportation Security Administration said 1.3 million Americans passed through airport security—the highest daily tally of travelers since the pandemic began, the Center for Infectious Disease Research and Policy reports. Many states are now bracing for a surge of new infections in the wake of the holidays. Hard-hit Southern California has told paramedics to conserve oxygen and not to bring patients with little hope of survival to hospitals. Meanwhile, COVID-19 patients now occupy 1 in 5 hospital beds in Texas—a record for the state, the Texas Tribune reported.
UPDATED: Tuesday, Jan. 5 at 3:07 p.m. ET
The European Medicines Agency is due to decide on Moderna‘s mRNA vaccine Wednesday. The agency’s human medicines committee (CHMP) met Monday to discuss the shot but said it would need to meet again on Wednesday. The EMA will also hold a public meeting Jan. 8 to outline its assessment, approval and vaccine rollout plans for European Union citizens, Politico reports.
Meanwhile, Moderna on Monday raised the low end of its global vaccine production estimate from 500 million doses to 600 million doses this year. The company is also planning new investments and hiring to potentially hit a target of 1 billion doses by year-end. The U.S. recently bought an additional 100 million doses from Moderna, and Canada and the European Commission expanded their orders last month. Story
The FDA put a planned phase 1 of Altimmune’s intranasal vaccine candidate on hold, which the company attributed to the need for protocol modifications and additional manufacturing and quality-control info. Altimmune’s candidate, AdCOVID, is an adenovirus type 5-vectored vaccine designed to offer protection after one dose. Story
Brazil is revving up for a national vaccination campaign, despite a dearth of injector devices, Reuters reports. The government plans to requisition surplus stocks from the country’s syringe and needle makers, the health minister said, after an electronic auction last week turned into a fiasco.
France is “accelerating and simplifying” its vaccination program as it lags behind its European neighbors, Olivier Veran, the country’s health minister, said Tuesday. France first focused on vaccinating nursing home residents and caretakers, but the government has now added healthcare workers and paramedics to that group. The plan is to start vaccinating people ages 75 and up by the end of the month.
Vaccine rollouts in other countries are also moving more slowly than expected, The New York Times reports. England aims to vaccinate some 13.9 million citizens from its four most vulnerable groups by February, Prime Minister Boris Johnson said, but as of Dec. 27, fewer than 800,000 people in the country had received the shot. In the U.S., around 4.5 million people have been vaccinated, well below the 20 million the government had aimed for.
India, which authorized AstraZeneca and Bharat Biotech’s shots Sunday, plans to launch its vaccination program next week, the country’s federal health secretary said. Around 29,000 cold storage facilities have been set up, and health officials carried out large-scale dry runs around the country. It’s aiming to vaccinate 300 million people by July.
The Republic of Palau, an archipelago in the Pacific Ocean with a population of around 18,000, hasn’t recorded a single coronavirus case or death since the pandemic began. With the arrival of 2,800 Moderna vaccine doses Saturday—which the country bought through the U.S.’ Operation Warp Speed program—Palau is on its way to becoming one of the first countries vaccinated against the disease, too, Fintech Zoom reports.
UPDATED: Tuesday, Jan. 5 at 9:34 a.m. ET
Mexico on Monday cleared AstraZeneca and the University of Oxford’s vaccine for emergency use, Hugo López-Gatel, the country’s top epidemiologist, tweeted. AstraZeneca in August laid out plans to work with the Mexican and Argentine governments to crank out 150 million initial doses for Latin America, with plans to later produce at least 400 million more doses for the region.
Israel Monday became the third country to authorize Moderna‘s mRNA vaccine behind Canada and the U.S. The country’s health ministry has locked down 6 million doses, and deliveries are expected to begin this month, Moderna said.
Belgium is set to receive half the doses of Pfizer and BioNTech‘s vaccine it ordered for January, thanks to an unspecified technical hiccup last month, Yves Van Laethem, a spokesman for the country’s health ministry, said. “The company Pfizer, which supplies us, will only be able to supply half of the planned doses for the month of January and so we go from 600,000 doses to a little over 300,000 doses.” Belgium on Tuesday started vaccinating residents and healthcare staffers at nursing homes.
In a statement issued Monday, FDA commissioner Stephen Hahn and Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said it would be “premature” and “not rooted solidly in the available evidence” to reduce the number of COVID-19 vaccine doses, extend the length of time between doses, alter the dose itself or mix and match vaccines to stretch supplies without supporting data. The UK. recently opted to delay peoples’ second vaccines in a bid to get initial shots out to more of the public. Story
The UK.’s Emergex Vaccines teamed up with Brazil’s Institute of Technology on Immunobiologicals of the Oswaldo Cruz Foundation—also known as Fiocruz—to develop a COVID-19 shot using Emergex’s next-gen T-cell vaccine tech. Emergex has so far completed preclinical development work on its shot, including toxicology and immunoproteomic research into the MHC Class I peptide expression library for cell surface expressed peptides on coronavirus infected cells, which define an effective T-cell response against the disease, Emergex said.
Inovio tapped fledgling biotech Advaccine Biopharmaceuticals Suzhou to help develop, manufacture and market its DNA-based vaccine candidate, INO-4800, in Greater China. In exchange for those exclusive Chinese rights, Advaccine will license its plasmid manufacturing process for use with the shot and other Inovio pipeline candidates, with the right to sublicense to Inovio’s manufacturing partners, the companies said. Inovio will receive $3 million upfront for the deal, and up to $108 million should the vaccine hit certain sales and regulatory milestones in China.
Novo Nordisk extended its COVID-19 patient assistance program until June 30, 2021—a bid to help people who’ve lost health insurance thanks to a job-status change during the pandemic. The program allows diabetes patients using Novo Nordisk insulin to receive insulin free of charge for 90 days. Patients can also potentially receive a free, one-time supply of up to three vials or two pen packs of insulin in instances where rationing may be a concern, Novo says.
An Advocate Aurora Health pharmacist who left out 57 vials of Moderna‘s vaccine was deliberately trying to spoil the shots because he feared they would mutate peoples’ DNA, the Associated Press reports. Wisconsin’s Steven Brandenburg, arrested last week, could face charges for the move that sent enough vaccine product for 500 people down the drain.
UPDATED: Monday, Jan. 4 at 3:26 p.m. ET
While the UK. is delaying second doses of AstraZeneca and Pfizer‘s vaccines to allow more people to get the initial shot, U.S. health officials are none too keen on the idea, The New York Times reports. “I would not be in favor of that,” NIAID director Anthony Fauci told Fintech Zoom last week. Others fear the country’s piecemeal approach to shot distribution would only be complicated further by the switch. “Doubling the number of doses doesn’t double your capacity to give doses,” Saad Omer, a vaccine expert at Yale University, told the Times.
South Korea kicked off its review of AstraZeneca‘s vaccine, with a view to approve the shot for emergency use in 40 days, the country’s drug safety ministry said. South Korea in December inked a deal for 20 million AZ doses, and initial shipments could arrive as early as this month. The country also has deals with Pfizer, Moderna and Johnson & Johnson, with plans to start vaccinations in February.
RedHill Biopharma’s oral SK2 inhibitor opaganib appears to help COVID-19 patients on oxygen support, phase 2 data showed, though a larger study is needed to confirm the experimental cancer med’s benefit. Among 40 participants who developed pneumonia and required oxygen, RedHill reported a 68% reduction in the median total oxygen needed for patients on opaganib, compared to a 46.7% reduction in the control arm. The company’s data reveal didn’t include a statistical analysis. RedHill launched a 270-subject phase 2/3 last summer and expects top-line results in Q1. Story
Acrotech Biopharma’s lymphoma drug Folotyn (pralatrexate) inhibited replication of the coronavirus more strongly than Gilead‘s antiviral Veklury (remdesivir), researchers at the Chinese Academy of Sciences’ Shenzhen Institutes of Advanced Technology (SIAT) found. The chemotherapy’s side effects could limit its use in COVID-19 patients, but the study supports the use of hybrid virtual screening for pandemic drug repurposing, the team figures. It used different AI platforms to screen a library of 1,906 currently marketed drugs that could bind to the coronavirus’s RNA-dependent RNA polymerase. Story
India’s Bharat Biotech signed a letter of intent with Malvern, Pennsylvania-based Ocugen to co-develop its inactivated vaccine, Covaxin, for the U.S. market. Ocugen is on deck for clinical development, registration, and commercialization stateside. The companies plan to finalize the deal “in the next few weeks,” while Ocugen says it has set up a vaccine scientific advisory board to chart the shot’s path to market. Bharat’s vaccine won an emergency nod in India on Jan. 3.
Meanwhile, Bharat’s authorization, which came just seven weeks after the drugmaker kicked off phase 3 trials, is taking heat from local experts, Fintech Zoom India reports. “The decision to approve an incompletely studied vaccine, even under accelerated process, raises more questions than answers,” a member of the All India Drug Action Network (AIDAN) said in a statement. The Indian government said it authorized Bharat’s vaccine on “safety and immunogenicity data,” but did not include efficacy data in its approval announcement.
UPDATED: Monday, Jan. 4 at 9:26 a.m. ET
By the third week of January, AstraZeneca aims to double vaccine production to 2 million doses per week, an anonymous staffer told Fintech Zoom. AZ has pledged 100 million doses to the UK., where its vaccine was authorized last week. The UK. government has said some 530,000 AZ doses should be available in the country Monday, local outlet Channel 4 News reported.
Meanwhile, 82-year-old dialysis patient Brian Pinker on Monday became the first person in the UK. to receive AstraZeneca and the University of Oxford’s shot following the late-December authorization.
AstraZeneca‘s vaccine snagged an emergency nod in India, where it’s being produced by Serum Institute of India (SII) under the name Covishield. SII has pledged to crank out 1 billion AZ doses for developing nations, including India. The country’s drug regulator also authorized Bharat Biotech’s inactivated shot Covaxin. The country has laid out a goal to vaccinate 300 million people—a mix of healthcare workers, older citizens and others—by August 2021.
Thanks to stockpiling efforts, Covishield doses are ready to roll out “in the coming weeks,” Serum Institute of India CEO Adar Poonawalla said. AstraZeneca‘s vaccine could be easier to store and distribute, too; unlike mRNA vaccines, which must be stored at ultracold temperatures, Covishield can be kept at 2 to 8 degrees Celsius (about 36 to 46 degrees Fahrenheit)—about as chilly as your standard refrigerator.
Moderna‘s mRNA vaccine, administered at two doses 28 days apart, proved 94.1% effective against COVID-19, phase 3 data published in the New England Journal of Medicine showed. The final analysis covered 196 coronavirus cases, with 185 cases observed in the placebo group and 11 cases recorded in the vaccine arm. Moderna is plotting additional trials of its vaccine in pregnant women, children below the age of 12 and special risk groups like the immunocompromised.
Moderna and the FDA are considering giving people a half-dose of the drugmaker’s shot to expedite vaccination efforts, Operation Warp Speed chief Moncef Slaoui told CBS. “We know it induces identical immune response,” he said of the half dose, adding that the move would help the government immunize “double the number of people with the doses we have.” U.S. officials originally outlined a goal to vaccinate 20 million Americans by the end of 2020. As of Saturday morning, the CDC said it had administered 4,225,756 vaccine doses out of a total 13,071,925 delivered. Story
A small number of people with facial fillers who received Moderna‘s vaccine in the company’s phase 3 study experienced facial swelling, the FDA advisory committee reviewing the shot said. “What happens is you take a vaccine and suddenly your immune system ramps up,” plastic surgeon Amir Karam told NBC 7 San Diego. “The thinking is basically because of that effect of the immune system it’s targeting the areas that you have filler in and causes a more robust inflammatory response.” The side effect is easily treated and shouldn’t discourage people from getting the vaccine, he added.
Pfizer and BioNTech are offering South Africa 50 million vaccine doses for healthcare workers between March and the end of 2021, though the cost is “prohibitive,” the country’s presidency, speaking on behalf of the African Union, told Bloomberg. South Africa is also in supply talks with Johnson & Johnson, Pfizer and AstraZeneca, which has directed the country to source its shots through Serum Institute of India.
Pfizer is pushing for people to receive their second vaccine dose within the recommended 21-day period, warning, “there is no data to demonstrate that protection after the first dose is sustained” after that time. Britain’s Joint Committee on Vaccination and Immunisation has since recommended vaccinating more people in at-risk groups before giving others their second doses.
UPDATED: Tuesday, Dec. 22 at 8:47 a.m. ET
Amid concern about the new coronavirus variant spreading in England, BioNTech CEO Ugur Sahin said the company is confident its vaccine will work against the strain. It’s “highly likely that the immune response by this vaccine also can deal with the new virus variants,” he said.
So far during the vaccination push with the Pfizer and BioNTech shot, there have been eight cases of severe allergy-like reactions, Science reports. There’s a growing suspicion among some scientists that polyethylene glycol, a compound in the mRNA packaging, could be responsible. Others doubt the link. The U.S. plans to investigate.
CureVac has launched another pivotal study for its coronavirus vaccine. The biotech started a phase 3 trial of its vaccine, CVnCoV, in healthcare workers in partnership with the University Medical Center Mainz. The trial will enroll 2,500 people 18 and older and test the vaccine against placebo for the workers, who are at a higher risk of becoming infected than the general population.
Johnson & Johnson originally planned to recruit 60,000 participants for its global phase 3 vaccine trial, but earlier this month said it would halt enrollment at around 40,000 people. The company says it can still seek a U.S. authorization in early 2021, but doctors at trial sites in South America were disappointed in the company’s decision to abruptly halt recruitment, Reuters reports.
Amid Novavax‘s push to complete vaccine testing and potentially seek an emergency use authorization, the biotech has named a chief operating officer. Rick Crowley, who previously served at TerSera Pharmaceuticals, Crealta Pharmaceuticals and other companies, is joining the biotech.
Following the Committee for Medicinal Products for Human Use‘s endorsement of Pfizer and BioNTech‘s vaccine, the European Medicines Agency has formally approved the shot. The distribution across Europe is set to start later this week.
The U.S. Attorney’s Office for the District of Maryland has seized and shut down fake websites claiming to represent Moderna and Regeneron. The sites stole user information for cyberattacks.
UPDATED: Monday, Dec. 21 at 3:02 p.m. ET
Codagenix and the Serum Institute of India (SII) launched a 48-subject phase 1 study in the UK. to assess the safety, tolerability and immunogenicity of their single-dose, intranasal COVID-19 vaccine. Dosing at an hVIVO-run site is pegged to start early next year. While that puts the partners well behind the leading developers in the vaccine race, Codagenix and SII’s candidate could carve out a niche if booster shots are needed to maintain protection against the virus. Plus, the partners’ candidate, COVI-VAC, is stable beyond the subzero temps needed to store Pfizer‘s shot. Story
IBM is pairing its Digital Health Pass app with Salesforce‘s online employee management platform, Work.com, to help businesses and public spaces reopen as COVID-19 vaccines become available. IBM‘s app aims to provide personalized, sharable health credentials after vaccinations, temperature checks and test results via an encrypted digital wallet on a smartphone, plus contract tracing and other services. Story
Beckman Coulter sketched out launch plans for a $4 antigen test designed for mass screening, with the goal to ship up to 25 million units per month by March. The Access antigen assay, which runs on high-throughput laboratory hardware, can deliver individual results in 30 minutes while processing up to 200 samples per hour. The company is currently submitting the test to the FDA for an emergency nod, Beckman Coulter said. Story
Walgreens Boots Alliance and CVS Health are spearheading a program, in partnership with the federal government, to vaccinate roughly 7 million people in more than 70,000 long-term care facilities across the U.S. While some residents received shots last week, the partners’ full rollout kicked off Monday, Reuters reports.
The FDA turned back Novartis’ cholesterol drug inclisiran—cornerstone of the Swiss Pharma’s $9.7 billion buyout of The Medicines Company—thanks to “unresolved facility inspection-related conditions.” The agency didn’t take issue with the drug’s safety or efficacy, Novartis said. The holdup is “essentially due to COVID-19 travel restrictions (FDA couldn’t inspect a third-party facility),” an RBC Capital Markets analyst wrote Sunday. It’s a fate shared by BMS’ CAR-T hopeful liso-cel, which recently had its approval timeline pushed back after the FDA missed an on-site inspection. Story
Most agree the industry’s pandemic pivot to digital marketing is here to stay. “[There’s] no going back now—we are going to digitalize healthcare,” Marie-France Tschudin, president of Novartis Pharmaceuticals, said in July. Meanwhile, pharma marketers and sales reps are getting more creative on the virtual front: Razorfish Health, for instance, created healthcare provider mailers for a new drug launch, complete with an Amazon Dash button, which, when pressed, sends out a request for a sales rep call or drug samples. Story
Meanwhile, telemedicine could be here to stay, too. Nearly 80% of specialists in the U.S. say they’ve started using telemedicine tech to reach more patients this year, a GlobalData survey found, with more than 75% of respondents saying they planned to keep using the tech after the pandemic. Elsewhere, digitally minded companies like Everlywell, Pear Therapeutics and Evidation Health have bagged millions of investment dollars to grow their telehealth offerings in 2020. Story
UPDATED: Monday, Dec. 21 at 9:05 a.m. ET
The FDA on Friday cleared Moderna‘s mRNA vaccine for emergency use in people ages 18 and older, teeing up immediate, nationwide distribution for the U.S.’ second authorized COVID-19 shot. Moderna plans to deploy 20 million doses to the U.S. by year-end, while Pfizer, first to authorization, has pledged 25 million doses. Both companies say they’re on track to deliver 100 million doses by the end of the first quarter, while Moderna recently agreed to supply 100 million more shots in the second quarter. Story
The EMA’s Committee for Medicinal Products for Human Use (CHMP) on Monday vouched for the conditional marketing authorization of Pfizer and BioNTech‘s mRNA vaccine in people ages 16 and older in Europe. The European Commission is set to review and potentially rubber-stamp the CHMP’s decision “in the near future,” Pfizer and BioNTech said in a release. If the commission grants Pfizer‘s shot a CMA, the decision will immediately extend to all 27 EU member states.
China aims to vaccinate 50 million people before Feb. 15—the date of the Lunar New Year, when many people are expected to travel, a Shanghai vaccine expert and former immunologist with the city’s CDC said during a teleconference with China’s National Health Commission. The country currently has five vaccine candidates in late-stage testing.
President-elect Joe Biden and incoming First Lady Jill Biden will receive Pfizer‘s vaccine on live television Monday morning. Meanwhile, Vice President-elect Kamala Harris plans to get her shot after Christmas, on the advice of doctors who suggested she and Biden stagger their first injections. Last week, Vice President Mike Pence became the highest-ranking elected U.S. official to receive the vaccine when he, Second Lady Karen Pence and Surgeon General Jerome Adams rolled up their sleeves to get Pfizer‘s shot—also on live TV.
With authorizations for Pfizer and Moderna‘s vaccines locked in, Johnson & Johnson is the next likely contender to apply for approval stateside, Admiral Brett Giroir, M.D., assistant secretary at the Department of Health and Human Services, told ABC News. J&J is expected to submit its adenovirus hopeful for authorization in January, Giroir said. The drugmaker last week said it had finished recruiting for its phase 3 trial and aims to deliver early efficacy data by the end of next month.
A new strain of COVID-19 first detected in the UK. spreads quickly, and work is underway to determine whether it leads to higher mortality, too, Chris Whitty, England’s chief medical officer, said in a statement Saturday. “As a result of the rapid spread of the new variant, preliminary modeling data and rapidly rising incidence rates in the South East, the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) now consider that the new strain can spread more quickly,” he said.
Italy on Sunday reported it had one patient infected with the new strain of the coronavirus found in Britain. The patient, now in isolation, recently returned from a trip to the UK., Italy’s health ministry said. Meanwhile, Australia on Monday confirmed it had identified two patients infected with the new strain.
UPDATED: Friday, Dec. 18 at 3:20 p.m. ET
Belgium’s budget state secretary, Eva De Bleeker, tweeted—and then deleted—the prices the EU has negotiated for Pfizer and Moderna‘s vaccines, The New York Times reports. Pfizer‘s shot, due for a European approval decision Monday, will cost €12 ($14.70) per dose, bringing up the cost for a full two-dose course to €24 ($29.38). Moderna‘s shot will cost $18 per dose, or $36 for a full course, according to the leaked price list.
The National Institutes of Health kicked off dosing in sub-studies of GlaxoSmithKline and Vir Biotechnology’s antibody hopeful, plus a two-antibody combo from Brii Biosciences. To start, researchers will test the two drug regimens against placebo in 450 subjects hospitalized with mild to moderate COVID-19. An initial readout, expected five days after dosing, will look at a range of factors like symptoms, how easily patients can perform daily activities and risk of death. If the drugs fare well, they’ll move into 700-subject trials that include patients with more severe COVID-19. Story
The FDA authorized a new version of Abbott’s speedy BinaxNOW antigen test that people can use at home with a prescription. Users aged 15 and up can take their own nose swab samples, while adults can use the swab on children as young as 4. Users are guided through the process via a telehealth connection. In partnership with digital service provider eMed, Abbott aims to deliver 30 million BinaxNOW tests by the end of March and another 90 million before the end of June. EMed, meanwhile, will pass off testing results to the relevant public health authorities. Story
COVAX, the World Health Organization’s equitable vaccine distribution scheme, has secured nearly 2 billion vaccine doses through additional supply talks with AstraZeneca and Johnson & Johnson, the alliance said Friday. COVAX aims to start deliveries in the first quarter of 2021, assuming the shots are approved. It expects enough doses in 2021’s first half to protect healthcare workers in all participating countries and economies and plans to deliver at least 1.3 billion doses to 92 low- and lower-middle income countries enrolled in the program sometime next year.
The vaccination will be televised. Vice President Mike Pence, second lady Karen Pence and Surgeon General Jerome Adams rolled up their sleeves to get Pfizer‘s vaccine on live television Friday morning, making Pence the highest-ranking elected U.S. official to get the shot. After receiving the vaccine, Pence said he hoped the move would “affirm to the American people that hope is on the way,” adding that he “wanted to step forward and take this vaccine to assure the American people that while we cut red tape, we cut no corners.”
UPDATED: Friday, Dec. 18 at 11:45 a.m. ET
The FDA’s panel of vaccine experts voted 20-0 Thursday, with one abstention, that the benefits of Moderna‘s mRNA shot outweigh the risks for people 18 and older. With Moderna‘s vaccine now positioned for a swift authorization, panelists did raise concerns that an emergency nod could disrupt the company’s ongoing trial. Others pointed to cases of facial paralysis—a condition known as Bell’s palsy—that cropped up during the study. The FDA is investigating the side effect but “has no basis to conclude a causal relationship” between the paralysis and the vaccine, an agency official said. Story
The European Commission tapped its option to purchase another 80 million Moderna vaccine doses, raising the bloc’s total purchase to 160 million doses. Moderna aims to kick off deliveries to Europe in early 2021, subject to regulatory approval. The European Medicines Agency’s scientific committee for human medicines is set to review the shot on Jan. 6, and then the European Commission will decide whether to authorize it.
Johnson & Johnson on Thursday said it had wrapped enrollment for its late-stage vaccine trial and expects to release initial efficacy data by the end of January. If all goes to plan, J&J aims to submit its vaccine to the FDA in February and apply for authorization in other countries “in parallel.” The phase 3 kicked off in September, with study sites up and running in the U.S., South Africa, Brazil, Argentina and several other Latin American countries. Meanwhile, Health Canada launched a rolling review of the vaccine late last month.
A healthcare worker in Alaska suffered flushing and shortness of breath 10 minutes after receiving Pfizer‘s vaccine, the states’ health department said. She had no previous history of allergies and is now in stable condition. Meanwhile, a second staffer at the same Alaskan hospital was hit with eye puffiness, lightheadedness and scratchy throat 10 minutes after receiving the shot, though this second case was not considered anaphylaxis.
Regeneron’s antibody cocktail successfully reduced viral load and the need for medical visits in non-hospitalized, recently infected COVID-19 patients, with the greatest benefit seen in those who’d yet to mount their own effective immune response or had high viral load at baseline, initial data from a phase 1/2/3 trial published in The New England Journal of Medicine showed. Regeneron’s cocktail won an emergency nod in late November to treat non-hospitalized, mild-to-moderate patients at high risk for progressing to severe COVID-19.
Speaking of Regeneron, President Donald Trump personally stepped in to help Housing Secretary Ben Carson get the drugmaker’s antibody cocktail after he was hospitalized with COVID-19 last month, Carson told Fox News. Carson initially tried to treat himself with oleander extract—an unproven treatment derived from a toxic plant, which Trump and MyPillow executive Mike Lindell pushed aggressively over the summer.
UPDATED: Thursday, Dec. 17 at 3:39 p.m. ET
After HHS secretary Alex Azar said Pfizer was having some issues with its COVID-19 vaccine production, the company refuted the statement on Thursday. Pfizer “is not having any production issues” and “no shipments containing the vaccine are on hold or delayed,” the company said. At a press event Wednesday, Azar said the government had “recently been informed by them, finally, of various challenges” in the manufacturing process. Story
The United States’ second COVID-19 vaccine could be nearing an FDA emergency authorization. On Thursday, an advisory committee met to discuss Moderna‘s application, with C-SPAN streaming the event. A vote on whether to recommend Moderna‘s vaccine was expected around 5:15 p.m. ET.
Meanwhile, the effort to scale up COVID-19 vaccines is affecting other medicines in the pharmaceutical supply chain. Horizon said its thyroid eye disease med Tepezza will run scarce from the end of the month into 2021 as its contract manufacturer Catalent helps with coronavirus vaccine production. Story
Throughout the pandemic, market watchers have wondered whether the pharmaceutical industry would see major reputation gains. A new study in the UK. from Takeda finds that’s not the case, as only 17% of adults surveyed in October said their perception of the industry had improved. Story
UPDATED: Thursday, Dec. 17 at 11:23 a.m. ET
Vials of Pfizer‘s vaccine, designed to hold five doses, contain enough product for pharmacists to squeeze out a sixth or seventh dose, Stat News first reported. Without clear manufacturer or regulatory approval, that extra supply has so far been discarded. Now, the FDA is suggesting healthcare workers “use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue,” an agency representative told Reuters.
Speaking of Pfizer, why hasn’t CEO Albert Bourla taken the drugmaker’s vaccine yet? “I’m 59 years old, in good health, I’m not working on the frontline, so my type it is not recommended to get vaccination now,” he told Fintech Zoom, suggesting it would “set a bad example” to “cut the queue.”
Japanese health authorities have questions about the efficacy of Fujifilm’s flu med Avigan in COVID-19, Kyodo News reported. Fujifilm started seeking approval in October after late-stage data showed its antiviral sped recovery time in patients with less-severe symptoms. Japan’s drug regulator is due to make a decision on Dec. 21, though it’s concerned doctors involved in the trial were aware which patients got the drug or placebo, government sources told Kyodo.
Utah’s Intermountain Healthcare says it’s trained a dedicated team, dubbed “the MAb Squad,” to contact high-risk individuals the moment they receive a positive COVID-19 testing result, helping connect them with infusion centers to receive Eli Lilly and Regeneron’s monoclonal antibody drugs. Demand for the companies’ antibodies, which must be administered soon after a person contracts COVID-19, has been underwhelming, Operation Warp Speed’s Moncef Slaoui said Wednesday.
Some 15,000 people in Moscow have received Russia’s Sputnik V vaccine since the the country kicked off large-scale vaccination efforts on Dec. 5, but enthusiasm for the shot has been mixed, the Los Angeles Times reports. Russia approved its shot this summer before wrapping up late-stage trials. It has since kicked off a phase 3, though public confidence may already be damaged. An October poll from the country’s Levada Center found 59% of Russians were unwilling to get the shot, with many wary that the “raw” vaccine was rushed to secure a world-first approval.
UPDATED: Wednesday, Dec. 16 at 3:15 p.m. ET
Most U.S. doses of Regeneron and Eli Lilly’s antibodies remain unused, Operation Warp Speed chief Moncef Slaoui told CNBC. Of some 65,000 total doses shipped out each week, only 5% to 20% end up reaching patients, he said. Some hospitals say they’re too overwhelmed to handle the logistics of prioritizing patients for treatment. As The Verge points out, patients also have a narrow window of time—soon after contracting COVID-19—when they could benefit from Lilly and Regeneron’s drugs.
A lab technician at a Sanofi vaccine plant in Swiftwater, Pennsylvania, sued the company and the staffing firm Yoh for failing to deliver pandemic hazard pay as promised. A project manager this spring emailed more than 60 technicians to offer a 15% pay bump for the duration of the pandemic as compensation for “increased risk of exposure,” but as the weeks went on, employees noticed their wages hadn’t increased, the lawsuit alleges. The staffers were ultimately offered three extra days paid time off, the suit says, which the same manager later told them was “in lieu of hazard pay.” Story
The FDA cleared Ellume’s over-the-counter, home COVID-19 test for emergency use. The Ellume COVID-19 Home Test detects fragments of proteins of the coronavirus from a nasal swab and uses an analyzer that connects with a smartphone app to help users perform the test and interpret results. Ellume expects to crank out some 3 million tests by next month and 20 million by the second half of 2021. Story
Data analytics firm nference picked up $60 million in a series C funding round, building on a previous $60 million it raised in January. With the new cash, the company says it will to broaden its focus to include “biomedical data analytics to better understand the novel coronavirus.” This includes nference’s recent project to demystify COVID-19 transmission, the symptoms and progression of the disease and “diagnostic predictions of chronic and life-threatening conditions such as pulmonary hypertension,” the company said. Story
French shot developer Valneva kicked off a phase 1/2 trial of its inactivated, adjuvanted vaccine hopeful. The vaccine leverages the manufacturing platform of the company’s approved Japanese encephalitis shot, Ixiaro, Valneva said in a release. To start, the company will study the safety and immunogenicity of three dose levels in around 150 healthy adults at sites across the UK. Valneva aims to pick an optimal dose by 2021’s second quarter and, if all goes to plan, believes it could snare an initial approval as early as the end of next year.
British American Tobacco—well-known for its cigarette brand Lucky Strike—bagged U.S. approval to run in-human trials of a COVID-19 vaccine made using tobacco plants, The Guardian reports. The company’s biotechnology division, Kentucky BioProcessing (KBP), says it can turn tobacco crops into “bio-manufacturing factories” by inserting a potential antigen into the plants for reproduction. The company’s unusual approach could be faster, too: up to 3 million “factory” plants can be grown, harvested and processed within six weeks, KBP said.
UPDATED: Wednesday, Dec. 16 at 9:31 a.m. ET
Pfizer is in talks with the U.S. government to free up supplies for extra vaccine doses, The New York Times reports, citing sources close to the matter. Pfizer may be able to manufacture more shots for the U.S.—beyond the 100 million it’s pledged to deliver by March—if the government orders its suppliers to prioritize its purchase requests. The company is now hashing out a contract with the government to potentially provide more doses from April to the end of June, NYT said. Story
White House press secretary Kayleigh McEnany on Tuesday said the Trump Administration was angling for an additional 100 million Pfizer doses, but didn’t specify when the order might arrive. Pfizer “can provide” the doses, CEO Albert Bourla told Fintech Zoom earlier this week, but he added that “most of that we can provide in the third quarter.” The two parties are working “collaboratively” to find ways to produce more doses in the second quarter, he said.
Meanwhile, the Trump Administration turned down an offer to secure more Pfizer doses as recently as November, former FDA commissioner and Pfizer board member Scott Gottlieb said on CNBC’s Squawk Box. “I think hopefully we’ll find a way to increase supply and be able to get the government what the government needs,” he said.
BioNTech will supply 100 million vaccine doses to China as part of an agreement with the country’s Shanghai Fosun. The company will source the initial shipment from its production facilities in Germany. BioNTech and Fosun first teamed up in March to develop and commercialize a shot using BioNTech‘s mRNA platform. The companies kicked off a phase 2 trial of the vaccine in China in late November. Meanwhile, BioNTech and Pfizer‘s vaccine already boasts an emergency nod in countries like the U.S. and the UK.
Long Island-based Codagenix got the OK to start a phase 1 trial of its nose drop COVID-19 vaccine in the UK. The 48-subject trial is slated to kick off in the first week of January. Codagenix’s candidate, COVI-VAC, is designed to work after one dose and “may induce a more robust immune response and long-lasting cellular immunity,” the company said.
The University of California, San Francisco, is set to receive its first allocation of Pfizer doses in mid-December—but that’s just the start of the journey, Desi Kotis, chief pharmacy executive at UCSF health, told Fast Company. Once the university starts vaccinating people, it will send the CDC and the California Department of Public Health an accountability log of the number of doses administered each day. Meanwhile, the school is working with ethicists, doctors and health equity experts to determine who should receive the first doses.
The drug manufacturing industry in Bihar, India, is having a rough go of it amid the pandemic, and the government seems unwilling to help, Pharmabiz reports. The coronavirus has spurred losses of production, revenue and employment in the industry. Earlier this year, drug manufacturing facilities in Baddi, Himachal Pradesh, India, shut down after the region was declared a COVID-19 containment zone.
Amid pandemic supply constraints, South Africa is facing shortages of lithium, used to treat bipolar disorder, and the injectable contraceptives Depo-Provera and Nur-Isterate, made by Aspen Pharmacare and Bayer, respectively, Ruth Dube, project coordinator at the Stop Stockouts Project—a non-profit that looks to end medication scarcity—told Bloomberg. Meanwhile, Pfizer in September stopped South African manufacturing of intramuscular haloperidol, used to treat mood disorders, for “reasons beyond its control,” the company’s South African communications chief said.
UPDATED: Tuesday, Dec. 15 at 3:15 p.m. ET
Eli Lilly’s antibody treatment bamlanivimab and its immunology med Olumiant could add up to $2 billion in COVID-19 sales this year, the drugmaker said Tuesday. Pandemic profits, plus strong demand for several core products like Lilly’s diabetes drug Trulicity and its psoriasis med Taltz prompted the company to hike its year-end revenue forecast to $24.2 billion to $24.7 billion. In 2021, Lilly predicts revenues will fall between $26.5 billion to $28 billion. Story
The U.S. government should invest in production of Eli Lilly and Regeneron’s pandemic antibodies as an “insurance policy” against COVID-19 next year, former FDA chief Scott Gottlieb wrote in The Wall Street Journal. The government could pay companies for access to their manufacturing space and help blunt the risks for those willing to become contract manufacturers for the treatments, he said. The government should also stockpile raw ingredients for the drugs at a “worthwhile” price, shoring up supplies ahead of next winter. Story
President-elect Joe Biden and Vice President-elect Kamala Harris should both get Pfizer‘s vaccine—as should President Donald Trump and Vice President Mike Pence, Anthony Fauci said Tuesday. Biden and Harris should get the shot as soon as possible, Fauci said, adding that Trump, who tested positive for COVID-19 in October, should also get one since his current level of natural resistance is unclear. Trump on Sunday said he wasn’t schedule to get the shot and suggested White House staffers wait until “somewhat later in the program” to receive one.
As shot authorizations start to trickle in, 71% of Americans say they would get a COVID-19 vaccine if it were free and proven safe and effective—up from 63% in September, a new Kaiser Family Foundation survey found. Twenty-seven percent of the public remains vaccine hesitant, with skepticism highest among republicans at 42%. Among Black adults—a group hit disproportionately hard by the pandemic—35% said they definitely wouldn’t or probably wouldn’t get vaccinated. The poll surveyed 1,676 people between Nov. 30 and Dec. 8.
The U.S. Defense Advanced Research Projects Agency (DARPA) awarded a $37.6 million grant to Inovio, the Wistar Institute, AstraZeneca, the University of Pennsylvania and Indiana University to leverage Inovio’s platform to develop DNA-encoded monoclonal antibodies (dMAb) against SARS-CoV-2. To start, Inovio and Wistar will construct dMAb candidates mirroring the recombinant antibodies AZ has already pushed into clinical studies.
Biogen’s ill-fated management conference has been linked to hundreds of thousands of coronavirus cases, researchers estimate in an article published in Science. As of Nov. 1, at least one viral variant that may have hitched a ride over from Europe with an attendee had made its way to 245,000 people in the U.S., while another that emerged during or right after the Biogen conference reached 88,000, the researchers said. Story
Russia’s Sputnik V vaccine is 91.4% effective, interim phase 3 data published Monday by the country’s sovereign wealth fund showed. The readout covered 22,714 participants who got either placebo or the vaccine in Russia’s late-stage trial. Seventy-eight people became infected with COVID-19 across both groups. Twenty severe cases were logged in the placebo arm, while no one who got the vaccine became seriously ill.
UPDATED: Tuesday, Dec. 15 at 9:20 a.m. ET
Moderna‘s mRNA vaccine won a thumbs-up from FDA staffers ahead of Thursday’s hotly anticipated advisory committee review. The agency reviewers highlighted the shot’s overall 94.5% efficacy rate, but noted that it appears to work better in patients under 65. Efficacy landed at 95.6% in that age group, compared with 86.4% for people 65 and older. The agency also vouched for the shot’s “favorable safety profile,” though many patients did experience mild side effects like injection site pain, fatigue and headaches, the FDA said. In an intriguing addendum to its own briefing documents, Moderna added its shot could prevent asymptomatic infection after one dose. Story
The European Medicines Agency aims to approve Pfizer and BioNTech‘s vaccine on Dec. 23, Germany’s Bild reported. The agency would make an approval decision by Dec. 29 at the latest, an EMA spokesperson added. Meanwhile, Germany could kick off vaccination efforts over the Christmas holiday, Bild reports.
The first round of efficacy data from Johnson & Johnson’s phase 3 vaccine trial could arrive in early January—potentially teeing up an emergency nod later that month, Warp Speed chief Moncef Slaoui said. AstraZeneca‘s efficacy readout is expected in late January, and the company could file for emergency use later in February, Slaoui said.
Some of Moderna‘s COVID-19 vaccine documents were breached in a cyberattack targeting the European Medicines Agency, the biotech said. None of the data Moderna submitted contained identifying information on study participants and so far, there’s no evidence that any trial subjects have been ID’d, Moderna said. Last week, the EMA revealed hackers behind the same attack had accessed documents from Pfizer and BioNTech. Story
Pfizer‘s shots are making their way across the U.S., CBS Philly reports. Temple University Hospital in Philadelphia expects to get 2,000 doses this week, with the goal to ultimately immunize between 7,000 and 8,000 patient-facing employees across its sites. Delaware on Monday received its first 9,000-dose shipment and will start giving the shot to frontline workers Tuesday. Meanwhile, the Cooper health system in New Jersey also plans to kick off vaccination efforts today.
All told, Pfizer‘s vaccine made it to 141 out of 145 target locations in the U.S. Monday, an HHS spokeswoman told Metro US. Healthcare facilities in the island territories of American Samoa, the U.S. Virgin Islands, the North Mariana Islands and Guam are still waiting on shipments, she said. Meanwhile, severe storms expected in the U.S. this week could hamper ongoing distribution plans, Operation Warp Speed’s Gen. Gustave Perna said.
AstraZeneca removed children from a phase 2/3 study of its vaccine hopeful in the UK., the United States clinical trial registry showed. Pfizer, Johnson & Johnson and Moderna are all testing their shots in kids to see how they work across a wider range of age groups.
The World Health Organization is in talks with Pfizer to include its shot in a global vaccine rollout, Bruce Aylward, a senior adviser at the agency, told Reuters. Aylward said he saw a “strong commitment” from Pfizer chief Albert Bourla to price shots fairly for poorer nations. Meanwhile, the agency expects to release information on additional manufacturers joining its COVAX vaccine facility in the coming weeks, he said.
Brazil’s Sao Paulo state plans to release efficacy data on Sinovac’s shot on Dec. 23, eight days later than planned, Reuters reports. That extra time will allow researchers to include data on a sample of 151 infected people, completing the analysis, the head of the state’s COVID-19 response said. Sao Paulo has set a vaccine rollout date for Jan. 25, though Sinovac’s shot has yet to win approval and has been met with frequent opposition from President Jair Bolsonaro.
China’s Sinopharm expects to have capacity to crank out 1 billion COVID-19 vaccine doses next year, Chinanews reports. The company has two inactivated vaccine candidates in phase 3 trials across 10 countries and regions, Yang Xiaoming, Sinopharm’s president, said. As it stands, Sinopharm’s plants in Wuhan and Beijing have a combined capacity of 300 million doses per year.