Pfizer Receives Positive FDA Advisory Committee Votes

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data is adequate to support the safety and effectiveness of its 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 candidate is currently under FDA review for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older.

“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,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We are encouraged by the outcome of today’s VRBPAC meeting as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market. We look forward to working with the FDA as it completes the review of our application.”

The VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including interim data from the pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease) announced with top-line results in August 2022 and presented at IDWeek 2022. Pfizer intends to publish these results in a peer-reviewed scientific journal.

The role of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding. The FDA’s decision on whether or not to approve RSVpreF for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in individuals 60 years of age and older is expected by the Prescription Drug User Fee Act (PDUFA) goal date in May 2023.

Burden of RSV

RSV is a contagious virus and a common cause of respiratory illness.1 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 individuals with certain chronic medical conditions.2,3,4 In the United States alone, among older adults, RSV infections account for approximately 60,000-160,000 hospitalizations and 6,000-13,000 deaths each year.5,6,7,8,9,10,11,12,13 Among children younger than five years old in the U.S., RSV infections account for approximately 2.1 million outpatient visits and 58,000-80,000 hospitalizations occur each year.8,14,15

RSV is a disease for which there are currently no targeted prophylactic, therapeutic, or vaccine options for older adults and the medical community is limited to offering only supportive care for adults with the illness.