FDA Advisory Panel Recommends Approval Of Pfizer Coronavirus Vaccine
PITTSBURGH (KDKA) -- An independent advisory panel to the FDA recommended emergency use authorization for the Pfizer coronavirus vaccine for Americans 16 and older.
Experts spent the day meeting and that led to a vote Thursday. The panel voted 17-4-1 in favor of authorizing the vaccine.
It is expected the agency will follow the recommendation. Once approved, the first doses could come within days.
"We really have the best of the best who are looking at this," says Kelly Stefano, Ph.D., the director of microbiology at the Allegheny Health Network.
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To qualify for EUA, there has to be a serious, life-threatening emergency, the product must be effective, the benefits must outweigh the risks and there must be a lack of alternatives.
"I do think that the question they have to ask is: does the benefit outweigh the risk? As far as I can see so far, I do think that is in fact true," Dr. Stefano says.
The panel members presented information on EUA criteria — patterns of disease, hospitalizations, and death — and monitoring safety and effectiveness after EUA.
One panelist discussed distribution issues, such as cold storage, mixing technique, use within six hours and a minimum large order which could make it impractical for rural areas.
"Unfortunately, when you go through the emergency process and rapidly try to develop, some of those details haven't been tweaked completely," says Dr. Stefano.
Also, there was a discussion of research ethics with EUA. Would people in the placebo group want to leave the study and get an active vaccine and would further placebo-controlled trials even be feasible?
"The problem is you compromise the true double-blinded concept of a vaccine trial," Dr. Stefano said. "From a scientific standpoint, I understand and want to keep that as valid as possible, for as long as possible, until all the data is obtained. From a personal standpoint, I can see people wanting that option."
Member of the public spoke, as well. Some people wanted the vaccine approved yesterday. Others wanted a longer study, more data on certain populations and information on whether the vaccine prevented asymptomatic infections.
"There's no way we could have covered every population of people, every demographic, every potential side effect and some of them will only be revealed in the long-term aftermath," says Dr. Stefano.
Pfizer had the last word on the vaccine's safety and efficacy.
"The efficacy is very, very impressive," says Dr. Stefano. "I did not see or hear about anything that was concerning from a safety standpoint."
In the pre-vote discussion, the panelists talked about issues around the placebo group and possible allergic reactions.
