The drug maker Pfizer said on Friday that it had submitted an application to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use, setting in motion an accelerated regulatory process that could allow the first Americans to get a vaccine by the middle of December.
Pfizer and its German partner, BioNTech, announced on Wednesday that the vaccine was safe and 95 percent effective, and that it also worked well in older people and in preventing severe Covid-19. Another front-runner, Moderna, said on Monday that its vaccine, which uses similar technology, was 94.5 percent effective and that the company also expected to apply soon for emergency authorization.
The two vaccines use a synthetic version of coronavirus genetic material, called mRNA, to program a person’s cells to churn out many copies of a fragment of the virus.
An emergency authorization would allow limited groups of Americans to get the vaccines before the F.D.A. has completed the typical monthslong approval process. Agency officials have made clear through new guidelines that their bar for emergency authorization will be high.
The F.D.A. regulators plan to take about three weeks to review Pfizer’s vaccine, which spans thousands of pages, before an outside panel of experts meets to review the application. That meeting has been scheduled for Dec. 10.
The agency typically, though not always, follows the advice of its advisory committees. If committee members reach a consensus about the effectiveness of Pfizer’s vaccine, the company could receive emergency clearance by mid-December.
Because Moderna is also on the verge of submitting its vaccine for emergency approval, the outside panel could review the company’s vaccine soon after Pfizer’s.
If both vaccines are authorized for emergency use, federal and company officials have said, there could be enough doses to immunize about 20 million Americans before the end of the year, a group that would most likely include health care workers and nursing home residents. There are an estimated 17 million to 20 million health care workers in the United States, and about a million people living in nursing homes.
In a video message Friday, Pfizer’s chief executive, Dr. Albert Bourla, called it a “historic day,” and said, “It is with great pride and joy — and even a little relief — that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the F.D.A.’s hands.”
Pfizer said on Friday that the company has begun regulatory submissions in Australia, Canada, Europe, Japan and Britain, and that it planned to apply in other countries “in the immediate future.”
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November 21, 2020 at 05:00PM
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Pfizer applies for emergency authorization of its vaccine. - The New York Times
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