A panel of outside advisers to the US 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 US.
Pfizer and BioNTech last month said a two-dose regimen of the vaccine is 95 percent 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.