Pfizer chief Albert Bourla penned a letter to employees explaining his aversion to the waiver Friday, publishing the text to LinkedIn in full. In the letter, Bourla explains how the Biden administration’s move will ultimately create more problems, particularly regarding the accumulation and production of raw materials.
Bourla emphasized that there had been no infrastructure in place to create mRNA-based medicines or vaccines at the start of the pandemic, claiming Pfizer had to build such a system from scratch. Roughly 280 different components or raw materials go into making the vaccines, Bourla wrote, supplied from 19 different countries.
Should the waiver go into effect, Bourla says companies “with little or no experience in manufacturing vaccines are likely to chase the very raw materials we require to scale our production, putting the safety and security of all at risk.”
The manufacturing aspect is important for Pfizer’s ability to continue providing vaccines to middle- and low-income countries, Bourla added, because it’s only now that such nations are signing supply agreements with the company. At the beginning of the pandemic, Bourla claims the majority of countries to take a chance on the mRNA tech were rich nations.
Bourla wrapped up his letter with the point that the IP waiver could disincentivize risk-taking for smaller biotechs and their investors.
Pfizer has made commitments to supply 2.5 billion of their BioNTech-partnered vaccines this year, with internal goals to hit 3 billion in 2021 and 4 billion in 2022. Last week, the pharma submitted its BLA for full FDA approval in patients aged 16 and older. — Max Gelman
Germany makes J&J vaccine available to anyone who wants it — report
Nearly a month after Europe’s medicines agency concluded that the overall benefits of Johnson & Johnson’s Covid-19 vaccine outweigh the risks, Germany has decided to make the vaccine available to all adults, Reuters reported.
The news comes a few days after German magazine Der Spiegel reported that the country’s vaccine committee would recommend J&J’s shots only for those over the age of 60. Health Minister Jens Spahn has said anyone will be able to receive the vaccine with a doctor’s recommendation, according to Reuters.
The EMA acknowledged a possible link between J&J’s Covid-19 vaccine and rare cases of unusual blood clots associated with low platelets on April 20. All of the cases occurred in people under 60 years old, the majority of them women. As a result, the agency’s safety committee recommended that the events should be listed as rare side effects of the vaccine that can occur about one to three weeks post-vaccination.
“One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin induced thrombocytopenia, HIT,” the agency announced.
The US lifted a pause on the vaccine back on April 23, allowing anyone to get the shot. The FDA updated the fact sheets for vaccine recipients and providers to note the risk of thrombosis with thrombocytopenia syndrome (TTS).
At the time, the CDC said it had tracked 15 cases of TTS, among about 8 million receiving the vaccine. That includes three deaths, seven people hospitalized, four of whom are in intensive care, and five people discharged.
The EMA said the cases it reviewed were “very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.”
Last week, German officials also opened up the AstraZeneca vaccine to anyone who wants it, according to Reuters. — Nicole DeFeudis
WHO authorizes Sinopharm vaccine for emergency use
The World Health Organization has added the newest entrant to its list of approved Covid-19 vaccines for emergency use: Sinopharm.
The authorization gives the Chinese drugmaker the ability to supply its vaccine to WHO sponsored programs such as COVAX, the Washington Post was among those to report. It’s also the first Chinese-made vaccine to have received emergency authorization from the organization.
Sinopharm’s vaccine comes in a two-dose regimen for individuals over 18 years old. It utilizes an inactivated form of the coronavirus and has already seen 65 million doses administered, but concerns have arisen regarding the shot’s side effects.
In a report last week, the WHO’s strategic advisory group for immunization noted that the Sinopharm shot had a 79% efficacy rate for those aged 18 to 59, similar to rates seen by the AstraZeneca/Oxford University vaccine. But the report highlighted a “low level” of confidence for efficacy in patients over 60, citing a lack of data.
Sinopharm’s vaccine becomes the seventh to obtain authorization from the WHO, following those from Pfizer/BioNTech, Moderna, J&J and three versions of the AstraZeneca shot, depending on where the vaccine was produced. — Max Gelman
For a look at all Endpoints News coronavirus stories, check out our special news channel.
Gilead Stock – Bourla pushes back against IP waiver in public letter; Germany makes J&J vaccine available to anyone who wants it — report – Endpoints News
Tags: Gilead Stock
Stock Market, Latest News on C N N.