U.S. Drug Advisory Panel Meets Today on Pfizer’s COVID Vaccine

By and | December 10, 2020

A panel of outside advisers to the U.S. Food and Drug Administration is meeting on Thursday to weigh whether to recommend that the agency authorize Pfizer’s coronavirus vaccine for emergency use, one of the last steps before vaccinations could begin.

The committee of outside experts is expected to vote on whether the vaccine, developed along with German partner BioNTech, has shown effectiveness in preventing COVID-19 and if the benefits of taking the shot outweigh the risks.

They are also likely to discuss potential safety concerns after two vaccine recipients in Britain reported anaphylactoid reactions associated with receiving the shot.

The country’s regulator on Wednesday advised some people with a history of anaphylaxis, an overreaction of the body’s immune system, related to medicine or food should avoid the shot.

The panel is expected to vote on its recommendations towards the end of the meeting, after presentations from the FDA, Pfizer, other public health officials and members of the general public. The FDA is expected to make a decision on the vaccine in the days after the meeting.

Documents prepared by the agency ahead of the meeting did not point out any new safety or efficacy issues, raising hopes the vaccine will soon be authorized in the United States.

Pfizer and BioNTech last month said a two-dose regimen of the vaccine is 95% effective against COVID-19, and detailed data released in the agency’s documents showed the vaccine began showing some protection even before volunteers received a second dose.

The documents also disclosed data on safety including cases of Bell’s palsy among volunteers in the placebo and vaccine groups, though it said the cases in the trial occurred at the same rate as in the general population. Other reactions included fever, fatigue and chills.

The vaccine has been authorized for use in Britain, Bahrain and Canada, and vaccinations have begun in Britain.

(Reporting by Manas Mishra in Bengaluru; editing by Caroline Humer and Nick Zieminski)

Top Photo: This May 4, 2020, photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. On Nov. 9, 2020, Pfizer said an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19. (Courtesy of University of Maryland School of Medicine via AP, File)

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