Pfizer: FDA accepts for review BLA for RSV vaccine candidate

Pfizer announced that the U.S. FDA has accepted for review a Biologics License Application for its respiratory syncytial virus vaccine candidate PF-06928316 or RSVpreF for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. This decision follows the FDA’s Breakthrough Therapy Designation for RSVpreF in March 2022. The FDA has accepted the BLA for priority review and has set a Prescription Drug User Fee Act action date of August 2023.