Booster meeting outcome: FDA, manufacturers no longer aligned on COVID

An FDA advisory committee’s decision to dial-back Pfizer’s request that it recommend approval of a booster dose for everyone who has received its Comirnaty COVID-19 vaccine flowed from the advisers’ rejection of the company’s contention that waning vaccine efficacy poses an imminent risk of serious or fatal illness to all fully vaccinated individuals.

The conduct and outcome of the advisory committee meeting reflected tensions between senior vaccine reviewers and agency leadership, confusion over the roles of FDA and CDC in setting vaccine policy, and an erosion of the close alignment between regulators and vaccine developers that characterized the first year of the pandemic. ...