A government advisory panel is debating Pfizer’s coronavirus vaccine Thursday and will decide whether its benefits outweigh any risks, clearing a path for the Food and Drug Administration to grant emergency approval so that states can begin to inoculate health workers and nursing-home residents.
FDA regulators don’t have to listen to the advisory committee but they are expected to follow its advice.
“Our plan is to take their recommendations into account for our decision making and make a decision shortly thereafter,” FDA Commissioner Stephen Hahn told NBC’s “Today Show.” “We intend to act quickly.”
Regulators are expected to grant emergency-use authorization within days, after Pfizer wowed scientists with data on the shots it developed with German company BioNTech. Once that happens, millions of vaccine doses will be loaded onto FedEx and UPS planes for delivery to sites across America.
Pfizer requested emergency approval on Nov. 20 after a final analysis showed its vaccine was 95% effective against COVID-19. Canada recently approved the vaccine and the U.K. started injecting it into people this week, raising pressure on U.S. regulators.
The FDA’s Vaccines and Related Biological Products Advisory Committee, which consists of disease experts and doctors, is expected to address potential allergy concerns after two British recipients had an adverse reaction.
Thursday’s meeting was being live-streamed for those interested in the arcane discussion about distribution and how people in the placebo arms of trials can access the vaccine.
“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said Dr. Doran Fink, a deputy FDA clinical director, said at the outset. “That’s what FDA physicians and scientists — all of us, career public health servants — have been doing over days, nights, weekends, and yes, over the Thanksgiving holiday.”
The panel met as the virus rages across the country.
Over 3,000 U.S. deaths from COVID-19 were recorded for the first time on Wednesday and more than 106,000 patients are hospitalized for the disease, taxing doctors and nursing across the country.
The FDA panel is scheduled to discuss another messenger-RNA vaccine, from Moderna, on Dec. 17. Officials on President Trump’s vaccine team believe the two versions will allow them to get shots into 20 million people before the end of the year.
The FDA set a high bar for COVID-19 vaccines to gain emergency approval, demanding standards that are nearly on par with a full biologics license.
Officials said the vaccines’ safety will be tracked closely. Regulators will also see how long the protection lasts and whether recipients are able to transmit the disease even though they don’t feel sick or show symptoms.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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