GSK plc announced that the US Food and Drug Administration (FDA) 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 US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50?59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals.
The annual RSV burden among US adults aged 18?49 years is about 17,000 hospitalizations, 277,000 emergency department admissions, and 1,970,000 outpatient visits. Most hospitalizations in younger adults occur in those with chronic medical conditions which place them at increased risk for severe RSV disease (e.g. chronic cardiopulmonary, kidney or renal disease, obesity and diabetes). The FDA?s decision was supported by 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 US approval, with the most common adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination. GSK continues to advance regulatory submissions for its RSV vaccine across multiple geographies to expand availability and support long-term growth objectives.
