Pfizer Reports Positive Phase 3 Trial Data for RSV Vaccine in Older Adults
Pfizer Inc. announced positive top-line data from a Phase 3 clinical trial of its bivalent respiratory syncytial virus (RSV) vaccine candidate in adults aged 60 and older.
New York, NY – August 25, 2022 – Pfizer Inc. (NYSE: PFE) today disclosed positive preliminary results from its pivotal Phase 3 clinical trial, named RENOIR, evaluating its bivalent RSVpreF vaccine candidate in adults aged 60 and older.
The trial demonstrated vaccine efficacy of 66.7% against RSV-associated lower respiratory tract illness (LRTI-RSV) defined by two or more symptoms. For the primary endpoint of more severe disease, defined by three or more symptoms, vaccine efficacy reached 85.7%. An independent Data Monitoring Committee found the investigational vaccine to be well-tolerated with no safety concerns.
Pfizer intends to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in fall 2022 based on these findings. The company aims to provide protection against RSV, a virus that can cause severe respiratory illness in older adults.
RSV infections are estimated to cause approximately 177,000 hospitalizations and 14,000 deaths annually among older adults in the United States. Currently, there are no prophylactic or therapeutic options specifically for older adults, with treatment limited to supportive care.