Europe’s drug regulator started evaluating the COVID-19 vaccine from Pfizer and BioNTech for people as young as age 12. The “accelerated assessment” will examine data from an ongoing trial, and a decision could come as early as June, the EMA said.
Novavax is said to be nearing a finalized supply deal with the European Union for up to 200 million doses of its vaccine, an official told Reuters.
Canada’s National Advisory Committee on Immunization (NACI), which makes recommendations for the use of vaccines, advised residents who are offered Johnson & Johnson’s vaccine to weigh the risk of rare but serious blood clots, or wait for another vaccine entirely.
The worldwide case count stood at more than 153 million on Monday afternoon, with more than 3.2 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 Nov. 2 to April 28 can be found here. Entries from Aug. 11 to Oct. 30 are here. Entries from April 21 through Aug. 11 are here. Entries from Jan. 30 through April 20 are here.
UPDATED: Monday, May 3 at 3:30 p.m.
The European Medicines Agency (EMA) started an “accelerated assessment” of Pfizer and BioNTech’s COVID-19 vaccine, known as Comirnaty, for people aged 12 to 15. The EMA said its recommendation could come in June—unless additional information is needed—and would apply to all member states, pending the European Commission’s final consent.
Canada’s National Advisory Committee on Immunization (NACI), which makes recommendations for the use of vaccines, advised residents to weigh the risk of rare but serious blood clots reported among some Johnson & Johnson vaccine recipients and, if considered necessary, wait for a different shot. J&J’s vaccine, which has now been recommended for people 30 and older in Canada, is expected to be distributed across the country soon, CBC reports. The country had held its first shipments of the vaccine on Friday to verify its safety and quality.
Novavax told the European Union that it plans to deliver its vaccine to the bloc by the end of this year, a sign that a forthcoming supply contract could be announced as early as this week, Reuters reports, citing an EU official. Under the deal, Novavax would supply up to 200 million doses, providing the EU with booster shots to help contain the coronavirus and potentially guard against new variants, the official said. Story
AstraZeneca said it still plans to submit its vaccine for emergency authorization in the U.S. “in the coming weeks,” even though the nation has an ample supply of doses from companies like Pfizer, Moderna and Johnson & Johnson. CEO Pascal Soriot defended the drugmaker when grilled by reporters about its recent stumbles, pointing to AZ’s rollout across Europe and in India, where 300 million people are set to be inoculated by this summer. Story
UPDATED: Monday, May 3 at 9:00 a.m.
Pfizer CEO Albert Bourla said the drugmaker is discussing an “expedited approval pathway” with the Indian government to authorize its vaccine in the nation, which is facing a raging outbreak driven by variants of the virus. In a statement, Bourla said Pfizer would also donate $70 million worth of medicines to India, including steroids to reduce inflammation, anticoagulants and antibiotics.
The World Health Organization listed Moderna’s COVID-19 vaccine for emergency use for people ages 18 and older, a designation that will allow other countries to expedite their own approval process for the shot. Moderna’s vaccine is the fifth to receive emergency validation from the organization.
Moderna signed a supply deal with the global vaccine-sharing facility COVAX for up to 500 million doses of its mRNA shot with the option to procure an additional 466 million doses in 2022. The biotech said it would deliver an initial 34 million doses to the facility, which is backed by the World Health Organization, in the fourth quarter this year. Separately, Sweden donated 1 million AstraZeneca doses to COVAX, saying it plans to receive future shipments of vaccines from other companies, Reuters reports.
India and South Africa plan to review their proposal that would temporarily limit IP rights for drugmakers’ COVID-19 vaccines, Law360 reports. The countries said they will meet with other World Trade Organization members that have opposed the IP waiver, including the U.S. and EU, in an effort to find common ground.
UPDATED: Friday, April 30 at 3:20 p.m.
Pfizer will begin shipping doses of its mRNA vaccine made in the U.S. to Canada starting next week, Reuters reports, citing a senior official. Canada will become the second country outside the U.S. to receive doses of the drugmaker’s vaccine from its plant in Kalamazoo, Michigan, following Mexico. The country said it expects 2 million doses per week in May.
Pfizer and BioNTech announced that they’ve asked the European Medicines Agency to expand the use of their COVID-19 vaccine to people between the ages of 12 and 15. Currently, the pair’s vaccine is authorized in Europe for those aged 16 and older. The drugmakers said the request was based on early data from a phase 3 trial that showed the shot was 100% effective against COVID-19 among the more than 2,200 trial participants within that age group.
Some European Union member countries, including France and Germany, are still pushing the bloc to strike a supply deal with French drugmaker Valneva for its COVID-19 vaccine, sources familiar with the matter tell Reuters. The news comes just over a week after Valneva said it would no longer prioritize supply talks with the EU but rather try to sign deals on a country-by-country basis. Previous discussions were held in January for up to 60 million doses of the company’s inactivated vaccine candidate.
Gilead Sciences reported $1.5 billion in sales for its COVID-19 antiviral remdesivir during the first quarter, which helped offset declines for its HIV and hepatitis C drugs. Executives at the company said they anticipate remdesivir “will have an important role to play” over the next couple of quarters. The drug’s share of the U.S. market remains strong: Roughly half of hospitalized COVID-19 patients now receive the antiviral, which continues to “play a key role as a standard of care treatment” for patients globally, Gilead chief Daniel O’Day said. Story
Emergent BioSolutions CEO Robert Kramer said he takes “full responsibility” for the mishaps at the CDMO’s plant in Baltimore, which discarded millions of doses of Johnson & Johnson’s COVID-19 vaccine following a production mishap. Following the incident, Emergent announced a number of executive changes during the company’s earnings call. Mary Oates, who joined Emergent after 25 years at Pfizer, is now handling the contract manufacturer’s response to the FDA’s list of concerns at the Baltimore Bayview plant. Story
UPDATED: Friday, April 30 at 11:32 a.m.
Emergent BioSolutions has made more than 115 million doses of Johnson & Johnson’s single-dose COVID-19 vaccine, with some 60 million shots loaded into vials and ready for delivery, a person close to the matter told Bloomberg. The FDA has yet to clear those doses for release, however, and with a majority of American adults now vaccinated, new immunizations are slowing. Emergent has been under an intense spotlight after workers at its Baltimore plant mixed up ingredients for AstraZeneca and J&J’s shots, ruining a batch that contained up to 15 million J&J doses.
Pfizer exported the first U.S.-made doses of its BioNTech-partnered vaccine this week, starting with deliveries to Mexico. The country has locked up 10 million Pfizer doses so far and said it expected to receive 2 million doses this week, though it’s unclear how much of that shipment was made in the U.S., Reuters reports. As the U.S. makes headway on its vaccination drive, it’s faced mounting pressure to re-distribute surplus shots to other countries.
Argentina met with AstraZeneca to talk about “possible difficulties” in its vaccine production there, Reuters reports, citing the country’s health minister, Carla Vizzotti. During the meeting, Vizzotti also pressed AZ to lock down an estimated delivery schedule for the shots. Argentina last year struck a deal to receive roughly 22 million AZ doses, which it planned to produce locally and send to Mexico and the U.S. for finishing.
The UK.’s drug regulator on Thursday said it had received another 41 reports of rare blood clots in people after they received AstraZeneca‘s COVID-19 vaccine. In an update this week, the Medicines and Healthcare products Regulatory Agency said it was aware of a total of 209 clots with low platelet counts linked to the shot, up from 168 cases reported last week. The EMA has said AZ should list clotting as a “very rare” side effect of the shot. Meanwhile, the UK. has instructed people under the age of 30 to seek out an alternative vaccine.
Companies working on COVID-19 shots handed their executives some hefty pay packages in 2020, and Novavax, targeting an emergency nod for its protein-based vaccine candidate later this year, is no exception. President and CEO Stanley Erck reeled in roughly $48.09 million, while the company’s R&D lead, Gregory Glenn, M.D., scored $24.92 million, according to the company’s 2021 proxy statement.
UPDATED: Thursday, April 29 at 3:20 p.m.
The European Medicines Agency (EMA) said it will quickly review Eli Lilly‘s rheumatoid arthritis drug Olumiant, also known as baricitinib, for emergency use in hospitalized COVID-19 patients receiving oxygen. The regulator, which will review data from two randomized trials of hospitalized patients, told the news agency it expects a decision by July.
Israel’s Teva likely won’t strike a co-production deal with COVID-19 vaccine makers, although discussions are still ongoing, CEO Kare Schultz told Reuters. The company, which has the capacity to produce the shots in Israel and Europe, has offered to help, but “the key players that have actually been successful in developing the vaccines that have come to the market have found other partners or their own internal capacity,” Schultz said.
Moderna has increasingly heard from a mix of governments, public health officials and scientists that mRNA vaccines are the best way forward as variants of the coronavirus emerge, president Stephen Hoge, M.D., told Fierce Pharma in an interview. That’s because as variants spread, drugmakers are forced to “update their vaccines really quickly,” and mRNA offers the necessary speed for that response, Hoge said. Story
Total global spending on COVID-19 vaccines is projected to reach $157 billion through 2025, according to an annual forecast from IQVIA Institute for Human Data Science. This year alone, IQVIA projects spending of roughly $53 billion and $51 billion in 2022. The group sees a precipitous drop in total spending in 2023, to roughly $23 billion. Story
The European Union’s latest supply contracts for COVID-19 vaccines to be delivered in the next couple of years now have clear rules on what will happen if drugmakers fall short on their deliveries, Germany’s Health Minister Jens Spahn said. The EU took legal action against AstraZeneca this week for not adhering to its contract and providing a “reliable” plan to ensure timely deliveries.
UPDATED: Thursday, April 29 at 9:25 a.m.
Moderna said it’s ramping up its vaccine manufacturing and will boost its supply estimates as a result. The biotech said it’s now able to make up to 3 billion doses in 2022 and raised its bottom forecast this year from 700 million doses to 800 million. The company also announced that new data shows its vaccine can be safely stored at refrigerated temperatures for up to three months. Story
BioNTech’s CEO Ugur Sahin said he expects results by September from trials testing the company’s mRNA vaccine, developed alongside Pfizer, in babies as young as six months old, Reuters reports, citing an interview Sahin conducted German magazine Spiegel. Results from trials testing the vaccine in kids between the ages of five and 12 will be available in July, Sahin said.
Spanish pharmaceutical company Reig Jofre will begin manufacturing doses of Johnson & Johnson’s COVID-19 vaccine by the end of the second quarter. At the company’s new plant in Barcelona, Reig said it will be able to produce as many as 250 million doses annually.
French prosecutors have opened an involuntary manslaughter probe into three deaths among recipients of AstraZeneca’s COVID-19 vaccine, AFP reports. The prosecutors, who are taking over and combining three local cases, haven’t charged any entity or individual yet. According to the prosecutor’s office, plaintiffs are trying to determine whether the vaccine caused the deaths of their loved ones.
Roche said it’s seeking a fast-tracked emergency authorization for its COVID-19 antibody cocktail, a combination of casirivimab with imdevimab, in India and can begin supplying the country with the drug immediately once given the OK, the Business Standard reports. Roche is also expanding production of its arthritis med Actemra, which has shown mixed results in treating COVID-19 patients.
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