Pfizer’s RSV Vaccine ABRYSVO Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved ABRYSVO (respiratory syncytial virus vaccine [RSV]), a 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. 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.

Approval was based on inferred efficacy from the Phase III clinical trial 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. 

Among U.S. adults 18 to 49 years of age, 9.5 percent have an underlying chronic condition, such as obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease and asthma that puts them at increased risk of developing and being hospitalized for RSV-associated LRTD, and this rises to 24.3 percent among those 50 to 64 years of age.

“RSV represents a significant threat to younger adults with certain chronic conditions. After decades of vaccine research by the scientific community and Pfizer, we now have the opportunity to help alleviate the burden of RSV in this high-risk adult population,” said Aamir Malik, chief U.S. commercial officer and executive vice president at Pfizer. “With this approval, we are proud that ABRYSVO is now the only RSV vaccine indicated for adults aged 18 to 49 at increased risk for the disease, expanding on its existing indications for older adults and pregnant women.”