A Milestone Meeting For US FDA: Vaccine Reviews After COVID
The tandem reviews by a US FDA advisory committee of two RSV vaccine candidates from Pfizer and GSK is a milestone event for the agency. They are the first non-COVID vaccine BLAs to go to committee since the pandemic began – and the debut of the new vaccine office leadership at FDA.
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Advisory committee votes 10-2 that data are adequate to support safety of the vaccine in adults 60 and older, voicing concern about small potential safety signals after co-administration with influenza shot. Several members question rush to market with just one season of data.
Pfizer got positive standalone votes on safety and efficacy for its RSV vaccine in older adults at a US FDA advisory committee, but only three advisors – a minority of the 12-member panel – endorsed both the safety and effectiveness of the firm’s candidate.
The agency’s Vaccines and Related Biological Products Advisory Committee will consider simplifying and harmonizing the vaccine composition, as well as formalizing a system for likely annual US updates.