US COVID-19 Vaccine Booster Plan Also Boosts Pressure On FDA
The plan’s White House announcement was described as a transparency move, but meeting its 20 September target start date requires both the FDA and ACIP to act quickly on boosters.
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The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.
US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot
Advisory committee meeting reflected internal tensions among FDA staff on need for boosters and adequacy of the data; mRNA vaccine Comirnaty should be authorized for a third dose in populations at high risk for severe disease or exposure, panel says after overwhelmingly rejecting Pfizer's bid for booster approval in the 16-and-older population.
It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.