COVID-19 Vaccine ‘Booster’ Or Simply A Third Dose? US FDA’s Marks Starts To Reframe The Issue
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.
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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.
Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough
Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear if Pfizer has made the case to FDA that a booster dose is needed at this time or that they provided enough safety data.
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.