Pfizer Booster Dose Authorization From US FDA Has Age Caveat: At-Risk Populations 18 And Up
Executive Summary
Age limit wasn’t part of advisory committee’s vote on third shot of the COVID vaccine, but aligns with concerns about myocarditis in younger recipients.
You may also be interested in...
Full US FDA Independent Review Of Janssen Booster Data May Not Continue Post-EUA
The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.
Moderna's COVID-19 Vaccine Booster US FDA Panel Nod Driven By Pragmatism
Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.
Janssen Booster Evidence Draws Questions From US FDA, But Also A Nod Towards Benefits
Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.