(News Bulletin 247) – Pfizer today announces that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biologicals Advisory Committee (VRBPAC) has voted in favor of the efficacy and safety of its unadjuvanted bivalent vaccine candidate against respiratory syncytial virus (RSV).
The vaccine candidate is currently under review by the FDA for the prevention of medically tracked lower respiratory tract disease (MA-LRTD) and severe lower respiratory tract disease caused by RSV in infants from birth through six months of age by active immunization of pregnant women.
“If approved, our vaccine could be the first maternal vaccine to protect infants up to their first six months of life against this potentially serious infection,” said Annaliesa Anderson, Ph.D. vice president and chief scientific officer. at Pfizer.
The VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including the results of the primary analysis of the pivotal Phase 3 clinical trial announced in November 2022.
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