Expanding on its previous indication for adults aged 60 and older, the vaccine is now FDA-approved for adults 18 and older at increased risk of lower respiratory tract disease caused by RSV.
RT’s Three Key Takeaways:
- Expanded Approval for Younger Adults: The FDA has approved Pfizer’s RSV vaccine, Abrysvo, for adults aged 18 to 59 who are at increased risk of lower respiratory tract disease caused by RSV, expanding its previous indication for adults aged 60 and older.
- Focus on High-Risk Adults: This approval targets adults between 18 and 49 years of age with chronic conditions such as obesity, diabetes, and asthma, who are at heightened risk of severe RSV-related respiratory illness.
- Clinical Trial Support: The FDA’s decision is based on data from the pivotal phase 3 MONeT trial, which evaluated the vaccine’s safety, tolerability, and immune response in adults at risk for RSV-related disease, with further results expected to be published and presented in scientific forums.
Pfizer Inc announced that the US Food and Drug Administration (FDA) has approved Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) 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 previously included those 60 years and older.
“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,” says Aamir Malik, chief US commercial officer and executive vice president of Pfizer, in a release. “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.”
The FDA’s decision is based on inferred efficacy 1 from the pivotal phase 3 MONeT clinical trial, 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 US adults 18 to 49 years of age, 9.5% have an underlying chronic condition, such as obesity, diabetes, chronic obstructive pulmonary disease, heart failure, chronic kidney disease, and asthma 2 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.
In June 2024, the Advisory Committee on Immunization Practices updated its recommendation of RSV vaccines for use in adults aged 75 years and older and adults aged 60-74 years who are at increased risk for severe RSV disease.
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