Pfizer received approval from the FDA for ABRYSVO (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.
 
The decision is based on data from the Phase 3 clinical trial RENOIR, a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older. RENOIR has enrolled approximately 37,000 participants, randomized to receive RSVpreF 120 μg or placebo in a 1:1 ratio. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.
 
Trial results published in April showed 67% efficacy in preventing infections with at least two symptoms. Protection was even greater against more severe disease, defined as three or more symptoms of RSV-related illness.
 
RSV is a contagious virus and a common cause of respiratory illness worldwide. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. The severity of RSV disease can increase with age and comorbidities, such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.
 
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.
 
Pfizer reported positive results from the Phase 3 study evaluating the safety and immunogenicity of ABRYSVO co-administered with seasonal inactivated influenza vaccine (SIIV) in adults 65 years and older. Pfizer is initiating multiple clinical trials evaluating RSVpreF in healthy children ages 2-5; children ages 5-18 with underlying medical conditions; adults ages 18-60 at high-risk due to underlying medical conditions; and adults ages 18 and older who are immunocompromised and at high-risk for RSV.