Pfizer received approval from the U.S. FDA for ABRYSVO (Respiratory Syncytial Virus Vaccine), a bivalent RSV prefusion F (RSVpreF) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals who are at increased risk for LRTD caused by RSV, in individuals 18 through 59 years of age. 
 
The FDA decision is based on inferred efficacy from the Phase 3 trial (NCT05842967) MONeT (RSV I M munizati ON Study for Adul T s at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults at risk of RSV-associated disease due to certain chronic medical conditions, such as obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease, and asthma.
 
In May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older but in June 2024, the Advisory Committee on Immunization Practices (ACIP) voted to update its recommendation of RSV vaccines for use in adults aged ≥75 years and adults 60-74 years who are increased risk for severe RSV disease.  
 
In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. This was followed in September 2023 with ACIP’s recommendation for maternal immunization to help protect newborns from RSV seasonally.

On October 24, the CDC claimed that RSV immunization is only recommended for adults aged 75 and older, and in seniors 60 to 74 years who are at risk of severe disease. According to the CDC’s vaccine committee the benefits of RSV vaccination outweigh risks in these patient populations.