Pfizer: FDA accepts for priority review BLA for RSV vaccine candidate, RSVpreF

Pfizer announced that the U.S. FDA accepted for priority review a Biologics License Application for its respiratory syncytial virus vaccine candidate, PF-06928316 or RSVpreF, as submitted for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. Priority Review designation by the FDA reduces the standard BLA review period by four months. The Prescription Drug User Fee Act goal date for a decision by the FDA on the RSVpreF application is in May 2023. This decision follows the FDA’s Breakthrough Therapy Designation of RSVpreF in older adults in March 2022.