Real-World Evidence Will Take Center Stage At US FDA Advisory Committee On COVID Boosters
If regulators agree with Pfizer’s conclusions – and briefing documents suggest that’s a big if – about real-world studies showing Comirnaty’s effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.
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Biden Administration met its self-declared goal of launching a booster campaign ‘the week of September 20’ – but with a more complex messaging challenge than anyone could have wanted after US FDA authorization and CDC recommendation for a ‘booster’ dose of Pfizer/BioNTech’s COVID vaccine left considerable confusion about who should get a third shot.
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.