News and Commentary

Report: FDA Expected To Approve First COVID-19 Vaccine For Emergency Use Late Friday
Commuters wearing protective masks travel in a subway train in New York, U.S., on Thursday, Dec. 10, 2020. New York City had its credit rating cut by Fitch Ratings because of the impact the coronavirus pandemic is having on the city's economy.
Victor J. Blue/Bloomberg via Getty Images

The Food and Drug Administration is reportedly expected to issue an emergency use authorization to Pfizer’s COVID-19 vaccine candidate on Friday evening, a move that would authorize the first inoculations against COVID-19 for the U.S general public.  

According to The New York Times, the Pfizer vaccine approval was already expected to come as soon as this weekend, but FDA commissioner Dr. Stephen Hahn has since ordered the process to move fast enough to yield an authorization by the end of Friday. 

“People familiar with the F.D.A.’s situation say that regulators are now racing to complete a fact sheet, information for physicians and other required documents that go with the authorization. Pfizer must also review certain documents,” reports The Times

General Gustav F. Perna, chief operating officer for Operation Warp Speed, said Wednesday that the U.S. government expects 2.9 million Pfizer vaccines to be distributed within a week should the vaccine candidate obtain emergency authorization. 

Another 2.9 million vaccines will also be available, said Perna, but those vaccines have been earmarked for recipients to receive their follow-up dose three weeks later, according to The Times. Another half a million COVID-19 vaccines will go into reserve. 

The prospect of a looming vaccine authorization comes after an advisory panel recommended the FDA approve Pfizer’s vaccine on an emergency use authorization for Americans aged 16 and up. That said, the FDA panel’s recommendation isn’t binding. 

“This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review,” the FDA said Thursday. “Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.”

The CDC expects Pfizer to have 25 million doses of its vaccine available by the end of December, and another 15 million doses of the Moderna vaccine — a similar vaccine that is pending emergency authorization as well — in the same time frame should it also be approved, reports Stat News.

The Pfizer approval would also come at a time when CDC Director Dr. Robert Redfield has suggested that a drop-off in COVID-19 deaths in the U.S. will be unlikely for the next two to three months. According to data from The New York Times, at least 2,923 people died of COVID-19 in the U.S. on Thursday.

Pfizer, an American company, developed the vaccine with the help of the German biotechnology company BioNTech, and made headlines last month when they said that their vaccine had shown to be over 90% effective in clinical trials. A recent FDA analysis of the vaccine also found it to be 95% effective after two doses spaced 3 weeks apart. 

According to Pfizer, the 95% efficacy rate against COVID-19 comes one week after the second COVID-19 vaccine dose, which is given three weeks after the initial inoculation. 

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