FDA Expands Arexvy Vaccine Approval to Younger Adults at Risk

The FDA has expanded the approved age indication of Arexvy (Respiratory syncytial virus vaccine, adjuvanted; GSK) to adults aged 18 to 49 who are at increased risk for lower respiratory tract disease caused by RSV.¹ The vaccine was previously approved in the United States for adults 60 and older and for adults 50 to 59 at increased risk for RSV-related lower respiratory tract disease.¹ Arexvy is not indicated for use in pregnant individuals.¹

Sanjay Gurunathan, GSK head of vaccines and infectious diseases research and development, said the expansion addresses a significant medical need among younger adults with underlying conditions that raise their risk of severe RSV disease. ¹ He added the decision helps ease pressure on the healthcare system and reflects GSK's broader strategy of extending RSV prevention to more adult populations.¹ GSK said it continues to pursue regulatory submissions for the vaccine across additional geographies.¹

Study Data

The approval was supported by NCT06389487, an open-label, multicountry phase 3b trial designed to evaluate immunogenicity and safety in adults at increased risk for RSV-related lower respiratory tract disease.¹ The trial enrolled 1,458 participants across 52 sites in six countries, including 16 US sites. It compared 426 participants aged 18 to 49 with predefined chronic conditions against 429 participants aged 60 and older, all receiving a single vaccine dose. A separate cohort of 603 participants aged 18 to 49 was followed for adverse events only.¹

The primary endpoint measured RSV-A and RSV-B neutralization titers one month after vaccination in the younger cohort relative to the older cohort, and the response met the non-inferiority threshold.¹ Vaccine efficacy in the population supporting Arexvy's original approval had already been demonstrated in the phase 3 trial NCT04886596.¹Safety and reactogenicity results in the phase IIIb trial were consistent with findings from that earlier Phase III program.¹

Injection site pain was the most common local adverse event, while myalgia, fatigue, and headache were the most frequently reported systemic events, largely mild to moderate and transient, occurring within four days of vaccination.¹

Reference

1.GSK's RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk. GSK Press release. March 13, 2026. Accessed March 13, 2026
https://www.gsk.com/en-gb/media/press-releases/gsk-s-rsv-vaccine-arexvy-approved-in-us-for-expanded-age-indication-in-adults-aged-18-49-years-at-increased-risk/