Latest From Sue Sutter
‘If I had been in the room, I would have voted yes,’ CDC director says of ACIP. ‘This was a scientific close call. ... And that was how my recommendations came out after listening to all of their scientific deliberations.’
One Down, Two To Go: Pfizer/BioNTech Booster Decision Creates Pressure For More Extra Shot Authorizations
Inequity created by limiting the mRNA vaccine’s third dose to only those individuals who received a primary series of the same vaccine, as well as resulting operational complexities, warrant consideration of a mix-and-match approach with Moderna and J&J products, CDC advisors say; however, FDA appears most focused on vetting manufacturer-specific data on homologous boosting.
Advisory Committee on Immunization Practices fails to pass an interim recommendation endorsing third dose of vaccine in health care workers and others at risk of occupational or institutional exposure, with panelists raising concern that the target population was overly broad.
Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’
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.
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.