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Pfizer’s RSV Vaccine: Two Positive Votes Don’t Necessarily Add Up To AdComm Endorsement

 
• By Sarah Karlin-Smith

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.

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VRBPAC vote totals obscure panel’s conflicted stance on Pfizer’s RSV vaccine • Source: Shutterstock

Pfizer Inc.’s respiratory syncytial virus (RSV) vaccine for older adults got two positive votes at a 28 February US Food and Drug Administration advisory panel. The company spun that into the Vaccine and Related Biological Products Advisory Committee’s endorsement of approval for the vaccine, but a closer examination of the two votes paints a much more complicated picture.

The VRBPAC voted 7-4 with one abstention that the available data are adequate to support the safety of Pfizer’s Abrysvo (RSVPreF) when administered to individuals 60 years of age and...

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