Pfizer's ABRYSVO RSV Vaccine Granted FDA Approval for At-Risk Adults

On Oct. 22, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

A press release on the announcement said, “ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.”

Further, “The FDA’s decision is based on inferred efficacy 1 from the pivotal Phase 3 clinical 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. The company intends to submit results from MONeT for publication in a peer-reviewed scientific journal and for presentation at an upcoming scientific conference.”

Among U.S. adults 18 to 49 years of age, 9.5% have an underlying chronic condition that puts them at increased risk of developing, and being hospitalized for, RSV-associated LRTD, and this rises to 24.3% among those 50 to 64 years of age.