FDA Grants Priority Review for Pfizer’s RSV Vaccine


If approved, RSVpreF would be the first vaccine for administration to pregnant women to help protect against RSV disease in infants. The FDA has set an action date for August 2023.

The FDA has accepted for priority review Pfizer’s biologics license application (BLA) for the syncytial virus (RSV) vaccine candidate PF-06928316 or RSVpreF to prevent lower respiratory tract illness caused by RSV in infants. This decision follows the FDA’s Breakthrough Therapy Designation for RSVpreF in March 2022. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.

RSV is a contagious virus and a common cause of respiratory illness. The virus can affect the lungs and breathing passages of an infected people and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions. Among children younger than five years old in the United States, RSV infections account for approximately 2.1 million outpatient visits and 58,000 hospitalizations each year. Worldwide, RSV results in the death of about 102,000 children annually. Among adults 65 years and older, RSV infections account for about 60,000 to 160,000 hospitalizations and between 6,000 and 10,000 deaths each year in the United States.

Pfizer’s RSVpreF is bivalent vaccine candidate is composed of equal amounts of recombinant RSV prefusion F from subgroups A and B. It is designed to be given to pregnant women to prevent lower respiratory tract illness caused by RSV in infants from birth up to six months of age.

Annaliesa Anderson, Ph.D.

Annaliesa Anderson, Ph.D.

“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,” Annaliesa Anderson, Ph.D., senior vice president and chief scientific officer, Vaccine Research & Development, at Pfizer, said in a press release.

The application is supported the pivotal phase 3 trial MATISSE, which will be presented to the CDC’s Advisory Committee on Immunization Practices (ACIP), as well as during the ReSViNET Foundation’s 2023 Global Conference, on Feb. 23, 2023.

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