US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot

 
• By Sue Sutter
  
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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. 

Jaws of shark
A second, hastily written voting question on boosters allowed FDA leaders and the Biden Administration to snatch victory from the jaws of defeat. • Source: Alamy

US Food and Drug Administration leaders and the Biden Administration snatched victory from the jaws of defeat on 17 September when an advisory committee voted that Pfizer Inc./BioNTech SE’s Comirnaty mRNA vaccine should be authorized for a third or “booster” dose in populations at high risk for exposure to COVID-19 or resulting severe disease.

The Vaccines and Biological Products Advisory Committee’s unanimous vote on authorization for a high-risk population followed an overwhelmingly negative vote...

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