After ACIP Gambit, Pfizer, GSK Take RSV Vaccines To US FDA Adcomm
The Vaccines and Related Biological Products Advisory Committee is scheduled to consider the RSV vaccine candidates on 28 February and 1 March.
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FDA Panel Agrees GSK’s RSV Vaccine Is Effective But Wants More Data Before Approval
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’s RSV Vaccine: Two Positive Votes Don’t Necessarily Add Up To AdComm Endorsement
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.
As Vaccines Pipeline Gushes, Complex Communication Challenges Loom
CDC Advisory Committee on Immunization Practices prepares for expected US FDA approvals of new vaccines to prevent respiratory syncytial virus in older adults, chikungunya and dengue and clarified recommendations for high-valent pneumococcal vaccines.