AREXVY RSV Vaccine Approved for Expanded Age Indication

The U.S. Food and Drug Administration has expanded the approved age indication of AREXVY (respiratory syncytial virus vaccine, adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. AREXVY was previously approved in the U.S. for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50 to 59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals.

Approval was based on data from a Phase IIIb trial (NCT06389487) demonstrating a non-inferior immune response compared to adults aged 60 years and above. Vaccine efficacy was demonstrated in the earlier Phase III trial (NCT04886596). The safety profile was consistent with findings from the broader Phase III program that supported the initial U.S. approval, with the most common adverse events being injection site pain, fatigue, myalgia, headache and arthralgia within four days of vaccination.

“This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system,” said Sanjay Gurunathan, GSK head of vaccines and infectious diseases research and development. “We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations.”