By Manas Mishra and Michael Erman
(Reuters) -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.
FDA Commissioner Steven Hahn, ahead of the meeting on Thursday, said the agency was carefully reviewing all the data on Pfizer’s vaccine, including potential allergic reactions in the wake of the UK’s warning.
“We’re working very closely with our UK partners to understand what went on with respect to those allergic reactions,” Hahn told CBS News’ “CBS This Morning program, adding that the vaccine’s label would ultimately include any details about who the vaccine was recommended for – and who should not get it – after looking at the current clinical trial data if it is ultimately approved.
“FDA is the gold standard for regulatory approval or authorization of medical products,” he added. “If our career scientists say that the vaccine is safe and effective, I have complete confidence in that decision, and I think the American people should as well.”
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)
