On May 31, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved 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 FDA’s decision is based on the data from the pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease). RENOIR is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccinein 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. The results were recently published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.

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. In the U.S., the burden RSV causes in older adults is considerable. The severity of RSV disease can increase with age and comorbidities, such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.