
On May 31, 2023, the U.S. Food and Drug Administration (FDA) announced its approval of Pfizer’s vaccine ABRYSVOTM. The bivalent RSV prefusion F (RSVpreF) vaccine is indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older. ABRYSVO contains two preF proteins that strengthen protection against RSV A and B strains.
The FDA based its approval on the data from Pfizer’s phase 3 clinical trial, which tested and proved the vaccine’s safety and efficacy. RENOIR is an ongoing global, randomized, double-blind, placebo-controlled study. It includes approximately 37,000 participants ages 60 and older, who randomly receive either the vaccine or placebo in a 1:1 ratio.
“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century,” said Annaliesa Anderson, PhD, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “ABRYSVO will address a need to help protect older adults against the potentially serious consequences of RSV disease.”
According to the World Health Organization (WHO), RSV is the leading cause of respiratory illness worldwide. The highly contagious virus affects one’s lungs and breathing, which can cause severe illness or, in some cases, death. The Centers for Disease Control and Prevention (CDC) estimates that between 60,000 and 160,000 older adults are hospitalized due to RSV each year, and between 6,000 and 10,000 die. Therefore, the CDC has identified an increased risk of RSV in this population. The presence of comorbidities, such as COPD, asthma, and congestive heart failure, also affects the risk and severity of the disease.
“This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults,” said Edward E. Walsh, MD, Professor of Medicine, University of Rochester Medical Center, and principal RENOIR investigator. “[The FDA’s] approval of ABRYSVO recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease.”
Pfizer said it expects vaccine supply to become available in Q3 2023 in time for the beginning of RSV season in the fall. Additionally, Pfizer announced its intention to initiate clinical trials that will analyze RSVpreF in several groupings: healthy children ages 2–5, children with underlying medical conditions ages 5-18, adults with high-risk underlying medical conditions ages 18-60, and adults who are immunocompromised ages 18 and older.