Pfizer Inc. announced that the US Food and Drug Organization (FDA) has approved a Biologics License Application (BLA) for its respiratory syncytial infection (RSV) antibody candidate, PF-06928316 or RSVpreF, to treat Mama LRTI and serious Mama LRTI brought in newborn children from birth as long as a half year old enough by dynamic vaccination of pregnant people.
The FDA’s Breakthrough Therapy Designation for RSVpreF in March 2022 precedes this decision. The Prescription Drug User Fee Act (PDUFA) action date has been set for August 2023, and the FDA has accepted the BLA for priority review.
According to Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer, RSVpreF would help protect infants from the devastating effects of this infectious disease, which, despite being well-known, has been particularly evident this RSV season. If RSVpreF were granted approval, it would help protect infants from the moment they take their first breath.
Annaliesa Anderson added that they anticipate moving forward with the FDA and other regulatory authorities’ review of Pfizer’s RSV maternal vaccine candidate because of its significant potential to improve global health by preventing RSV in infants.
Pfizer’s marketing authorization application (MAA) for its RSV vaccine candidate for older adults and maternal immunization to help protect infants has also been accepted by the European Medicines Agency (EMA). In the second half of 2023, a decision should be made.