Pfizer’s Maternal RSV Vaccine Quest May Hinge On FDA Advisors’ Views of Preterm Birth Data

A numerical – but not statistically significant – imbalance in preterm births was seen in two Pfizer studies of its RSV vaccine when given to pregnant people with the aim of protecting newborns.

mom and infant
FDA’s advisors will vote 18 May on Pfizer’s maternal RSV vaccine program to protect infants • Source: Shutterstock

A numerical imbalance of preterm births in people who received Pfizer Inc.’s respiratory syncytial virus vaccine while pregnant in clinical trials is likely to be the key focus of the immunization’s 18 May Vaccines and Related Biological Products Advisory Committee meeting.

Pfizer is seeking approval for Abrysvo (RSVpreF) to prevent lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through six

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