If authorized, Pfizer’s RSV vaccine would be used to prevent respiratory disease caused by RSV in adults 60 years of age and older. An FDA decision is expected by May 2023.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data is adequate to support the safety and effectiveness of Pfizer’s respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF. The committee voted 7 to 4 on safety and 7 to 4 on effectiveness. The vaccine is currently under FDA review to prevent acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older. An FDA decision is expected in May 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 individual and can potentially cause severe illness in young infants, older adults, and those with certain chronic medical conditions. In the United States alone, among older adults, RSV infections account for about 60,000 to 160,000 hospitalizations and 6,000 to 13,000 deaths each year.
Pfizer’s bivalent vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B strains. The vaccine builds on discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of prefusion F, a key form of the viral fusion protein that RSV uses to enter human cells.
“In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population,” Annaliesa Anderson, Ph.D., senior vice president and chief scientific officer, Vaccine Research and Development, Pfizer, said in a press release.
The advisory committee reviewed data from the phase 3 RENOIR study. Topline results from this were release in August 2022. A data monitoring committee assessed protection against RSV-associated lower respiratory tract illness with two or more symptoms at 66.7%. Among patients with more severe disease, defined by three or more symptoms, the vaccine efficacy was 85.7%. The committee also indicated the vaccine was well-tolerated, with no safety concerns.
Pfizer also recently submitted this vaccine to the FDA 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 for this indication.