FDA Grants Priority Review to Pfizer’s BLA for RSV Maternal Vaccine Candidate

The FDA has accepted for priority review Pfizer’s biologics license application (BLA) for its vaccine candidate RSVpreF to vaccinate pregnant women to prevent complications of respiratory syncytial virus (RSV) in infants from birth up to six months of age.

RSVpreF previously received Breakthrough Therapy status in March 2022 for prevention of lower respiratory tract disease caused by RSV in older adults and gained a priority review in December 2022 for that indication. The agency’s target decision date for treatment of older adults is in May. 

The agency’s anticipated decision date for RSVpreF for pregnant women is in August.