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Pfizer’s RSV Vaccine: US FDA Panel Wants Robust Safety Program With Public Accountability

 
• By Sarah Karlin-Smith

Advisory committee offers strong support for approval of Pfizer’s RSV vaccine to protect infants while simultaneously offering the agency a handful of suggestions that were directed towards the review and post-market surveillance of all vaccinations.

babies
Pfizer’s maternal RSV vaccine got positive VRBPAC votes on 18 May • Source: Shutterstock

Pfizer Inc.’s maternal respiratory syncytial virus vaccine program got positive efficacy and safety votes from the US Food and Drug Administration’s vaccine advisors 18 May with the strong caveat from many members that rigorous post-marketing surveillance be required as part of an expected approval.

The Vaccines and Related Biological Products Advisory committee voted unanimously that Pfizer’s data package for Abrysvo (RSVpreF) is adequate to support the effectiveness of the vaccine in preventing RSV lower respiratory tract disease and severe RSV lower respiratory trace disease in infants from birth through 6 months

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