U.S. FDA Accepts Biologics License Application for Pfizer’s Respiratory Syncytial Virus Maternal Vaccine Candidate for Priority Review

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) 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 (PDUFA) action date of August 2023.

“If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer. “We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants.”

In addition, the European Medicines Agency (EMA) has accepted Pfizer’s marketing authorization application (MAA) under accelerated assessment for its RSV vaccine candidate for both older adults and maternal immunization to help protect infants. A decision is expected in the second half of 2023.

The maternal immunization regulatory submission is supported by the positive top-line results from MATISSE (MATernal Immunization Study for Safety and Efficacy), a Phase 3 clinical trial evaluating the efficacy, safety, and immunogenicity of RSVpreF against MA-LRTI and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy. These data will be presented on February 23 to the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) and, separately, during the ReSViNET Foundation’s 2023 Global Conference on Novel RSV Preventive and Therapeutic Interventions.