Biopharmaceutical company Pfizer Inc (NYSE:PFE) announced on Wednesday that the US Food and Drug Administration (FDA) has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), a bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals aged 60 years and older.

ABRYSVO consists of two preF proteins selected to optimise protection against RSV A and B strains. The vaccine was found to be safe and effective in a pivotal Phase 3 clinical trial involving approximately 37,000 participants. RENOIR, the global, randomised, double-blind, placebo-controlled study, assessed the efficacy, immunogenicity and safety of a single dose of the vaccine in older adults.

RSV is a contagious virus that can cause severe respiratory illness or death, particularly in older adults with comorbidities such as chronic obstructive pulmonary disease, asthma and congestive heart failure. An advisory committee for the US Centers for Disease Control and Prevention is scheduled to meet in June 2023 to discuss recommendations for the use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer expects the vaccine to be available in Q3 2023, ahead of the anticipated RSV season.

Pfizer is currently the only company pursuing regulatory applications for an RSV vaccine candidate targeting both older adults and infants through maternal immunisation. The company has also received priority review for a Biologics License Application (BLA) for RSVpreF for the prevention of lower respiratory tract and severe lower respiratory tract disease caused by RSV in infants up to six months of age by immunising pregnant women. The FDA is expected to take action on the BLA in August 2023.

Pfizer's RSVpreF vaccine is under review by the European Medicines Agency (EMA) for both older adults and maternal immunisation, and the company has also filed applications with the Ministry of Health, Labor and Welfare in Japan and Health Canada for the same indications.