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US FDA approves Arexvy for adults 18-49 AIR
GSK plc announced that the US FDA has expanded the approved age indication for its RSV vaccine, Arexvy, to include adults aged 18 to 49 years who are at increased risk for lower respiratory tract disease caused by RSV. This expansion is supported by data showing a non-inferior immune response compared to older adults, with a safety profile consistent with previous findings. The annual RSV burden in this younger adult demographic includes an estimated 17,000 hospitalisations and 277,000 emergency department admissions, with most hospitalisations occurring in those with chronic medical conditions. GSK is continuing regulatory submissions globally to broaden the vaccine's availability. Disclaimer*
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[{"type":"text","content":"\n\nIssued: 13 March 2026, London UK\n \nGSK's RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18-49 years at increased risk\n \n· In the US, an estimated 21 million adults under 50 have at least one risk factor for severe RSV infection[1]*\n \n \n\nGSK plc (LSE/NYSE: GSK) today 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. GSK's RSV vaccine 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.\n \nSanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: \"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.\"\n The annual RSV burden among US adults aged 18-49 years is about 17,000 hospitalisations, 277,000 emergency department admissions, and 1.97 million outpatient visits.[2]† Most hospitalisations 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).2†\n \nThe 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.[3] Vaccine efficacy was demonstrated in the earlier Phase III trial (NCT04886596).[4] The safety profile was consistent with findings from the broader Phase III programme 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.3\n GSK continues to advance regulatory submissions for its RSV vaccine across multiple geographies to expand availability and support long-term growth object...