A panel of outside advisers to the U.S. Food and Drug Administration on Thursday voted overwhelmingly to endorse emergency use of Pfizer Inc’s coronavirus vaccine, paving the way for the agency to authorize the shot for a nation that has lost more than 285,000 lives to COVID-19.
The FDA is widely expected to authorize the vaccine, developed with German partner BioNTech SE, for emergency use in the United States within days.
The committee voted 17-4 that the known benefits of the vaccine outweighed the risks of taking the shot for individuals 16 and older, with 1 member of the panel abstaining.
Pfizer has asked that the two-dose vaccine be approved for use in people aged 16 to 85. Several advisory panel members discussed whether 16 and 17 year olds should be included in the recommendation because the risk to these individuals is low, and the evidence in the trial was scant.
In the end, they voted on the question as put them by the FDA, which included 16 to 17 year olds. The FDA typically follows the advice of its expert panels, but is not bound to do so.
The panel also discussed concerns raised by two reports of serious allergic reactions among vaccine recipients in Britain and spent a large portion of the discussion on Pfizer’s plan to give volunteers who received a placebo in its trial the option to get the vaccine when they become eligible for it under recommendations set by state and local health officials.
Documents prepared by the FDA ahead of the meeting did not point out any new safety or efficacy issues, raising optimism that the United States would soon follow the UK and Canada authorizing the vaccine.
Britain’s health regulator on Wednesday advised some people with a history of anaphylaxis, an overreaction of the body’s immune system related to medicine or food, to avoid the getting the vaccine.
FDA Commissioner Steven Hahn, ahead of Thursday’s meeting, said the agency was carefully reviewing all the data on Pfizer’s vaccine, including potential allergic reactions following the UK warning.
He said the vaccine’s label would include details about who the vaccine was recommended for – and who should not get it – if it is ultimately approved.
Pfizer and BioNTech last month said a two-dose regimen of the vaccine was 95% effective in preventing illness from 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.
(Reporting by Manas Mishra in Bengaluru and Julie Steenhuysen in Chicago, Additional reporting by Michael Erman in Maplewood, NJ; Editing by Caroline Humer and Bill Berkrot)
