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. 

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

More from US FDA Performance Tracker

More from Regulatory Trackers