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Second RSV Vaccine Seeks Approval

May 17, 2023 • 6:18 pm CDT
U.S. FDA May 17, 2023
(Precision Vaccinations News)

The U.S. Food and Drug Administration (FDA) today published the Briefing Document for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) review of ABRYSVO™, a respiratory syncytial virus (RSV) vaccine.

Pfizer Inc.'s ABRYSVO is a bivalent vaccine candidate comprised of two preF proteins selected to optimize protection against RSV A and B. 

This digital meeting is scheduled for May 18, 2023, and starts at 8:30 AM ET and is open to the public.

The VRBPAC provides independent expert advice to the FDA on broad scientific topics or certain products to help the agency make sound decisions based on the available science.

GSK's AREXVY™ RSV OA single-dose RSV vaccine was previously approved by the FDA for seniors.

Furthermore, there are several other RSV vaccine candidates conducting late-stage studies.

Update May 18, 2023 - EXECUTIVE SUMMARY - This document summarizes the favorable benefit-risk profile for Pfizer’s RSVpreF (Abrysvo), a bivalent respiratory syncytial virus (RSV) stabilized prefusion F subunit vaccine (RSVpreF) for the proposed indication for prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age, by active immunization of pregnant individuals.

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