FDA expanded the approved use of GSK's RSV vaccine Arexvy to include adults aged 18 to 49 who are at increased risk for lower respiratory tract disease caused by RSV.

The approval expansion broadens access to a vaccine previously limited to older age groups.

RSV is not solely a disease in older adults, as among U.S. adults aged 18 to 49, the virus causes approximately 17,000 hospitalizations, 277,000 emergency department visits, and nearly 2 million outpatient visits annually.¹

The majority of hospitalizations in this younger age group occur in people with chronic medical conditions, the same population now eligible for Arexvy under the expanded indication.

The expanded approval for younger adults in the U.S builds on Arexvy’s expanded approval in Europe, which was announced in January of this year.³

What does the expanded approval cover?

Previously, Arexvy was only approved in the U.S. for both adults aged 60 and older and adults aged 50 to 59 at increased risk for RSV-related lower respiratory tract disease.¹ FDA’s decision to expand the indication will now allow adults as young as 18, provided they have underlying conditions that elevate their risk of severe RSV disease, including chronic cardiopulmonary, kidney, or renal disease, obesity, and diabetes, to use the vaccine.¹

As of March 13, the vaccine is not approved for use in pregnant individuals.

What data supported the decision?

The FDA's approval was supported by a Phase IIIb trial enrolling 1,458 participants across 52 locations in six countries, including 16 U.S. sites.² The trial demonstrated that Arexvy produced a non-inferior immune response in adults aged 18 to 49 at increased risk compared to adults aged 60 and older.

Vaccine efficacy for Arexvy was previously established in an earlier Phase III trial.² The safety profile remained consistent with prior data, with the most common adverse events being injection site pain, fatigue, muscle aches, headache, and joint pain, most of which were transient and mild to moderate in intensity.²

Sanjay Gurunathan, GSK's head of vaccines and infectious diseases research and development, said the expansion addresses a significant medical need for younger adults with underlying conditions and could help ease pressure on the healthcare system.

“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. We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations,” said Gurunathan.

Arexvy is now approved for adults aged 60 and older in 70 countries, for adults aged 50 to 59 at increased risk in more than 60 countries, and for all adults aged 18 and older in the European Economic Area.¹

GSK said it continues to advance regulatory submissions across additional geographies as part of its broader RSV vaccine strategy.

Sources

1. GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk GSK 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/
2. A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above National Library of Medicine September 5, 2025 https://clinicaltrials.gov/study/NCT06389487
3. GSK’s RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older GSK January 26, 2026 https://www.gsk.com/en-gb/media/press-releases/gsk-s-rsv-vaccine-arexvy-receives-european-approval-for-expanded-use-in-all-adults-18-years-and-older/