RSV Vaccine for Seniors Coming in May 2023

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF.

According to the U.S. CDC, RSV is a contagious virus and a common cause of respiratory illness for which there are currently no prophylactic, therapeutic, or vaccine options for older adults.

RSV incidence can vary each year. However, during 2022, there has been a significant resurgence in RSV cases.

This BLA was submitted to prevent lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

The FDA's Prescription Drug User Fee Act goal date for a decision on the RSVpreF application is in May 2023.

"With no RSV vaccines currently available, older adults remain at-risk for RSV disease and potentially severe outcomes, including serious respiratory symptoms, hospitalization, and in some cases, even death," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer, in a press release issued on December 7, 2022.

"The FDA's acceptance of the BLA for our RSV vaccine candidate is an important regulatory milestone in Pfizer's efforts to help protect older adults against RSV and demonstrates additional progress toward what has been an elusive public health goal – reducing the overall burden associated with this infectious disease."

Pfizer's RSVpreF vaccine candidate builds on foundational basic science discoveries, including those made at the U.S. National Institutes of Health, which detailed the crystal structure of prefusion F, a key form of the viral fusion protein (F) that RSV uses to enter human cells.

That research showed that antibodies specific to the prefusion form were highly effective at blocking virus infection,

Other RSV vaccine candidate news is posted at PrecisionVaccinations.com/RSV.