The Food and Drug Administration (FDA) bypassed many of its own protocols to speed through the authorization of Pfizer’s second booster dose of the COVID-19 vaccine last week.
Multiple medical experts, including some who sit on the FDA’s top vaccine advisory committee, said they had no idea why the agency skipped over its normal approval process to authorize the fourth vaccine dose for Americans aged 50 and older. The authorization was even broader than the drug company requested, which was that it be greenlit for those aged 65 and older.
That FDA vaccine panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), is meeting Wednesday, and part of the agenda will be to discuss the fourth vaccine dose and the Israeli studies which are being used to exhibit its effectiveness. Typically, the vaccine authorization process would involve a meeting and vote by VRBPAC on whether to recommend authorization, followed by the FDA head granting that authorization. Then, the Centers for Disease Control and Prevention’s (CDC) vaccine committee would vote on how to recommend the vaccine, which would then be determined by the CDC director.
Dr. Paul Offit, a co-inventor of the rotavirus vaccine and member of VRBPAC, said he couldn’t explain why the FDA didn’t present its data to the committee first before moving ahead with authorization: “The way it’s working here is that the government basically just declares that this is what they’re going to do.”
Hellbound and Down 