GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk

GSK plc has announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of Arexvy (Respiratory Syncytial Virus vaccine) to include adults aged 18 to 49 years who are at increased risk for lower respiratory tract disease (LRTD) caused by RSV. Earlier, GSK’s RSV vaccine had received approval in the US for preventing RSV-related LRTD in adults aged 60 years and above, as well as adults aged 50–59 who are at increased risk for LRTD due to RSV. The vaccine is not intended for use in pregnant individuals.

Sanjay 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.”

Among adults aged 18–49 years in the US, the annual RSV burden includes approximately 17,000 hospitalisations, 277,000 emergency department visits, and around 1.97 million outpatient consultations. Most hospitalisations in younger adults occur among those with chronic medical conditions that increase the risk of severe RSV disease, such as chronic cardiopulmonary, kidney or renal disease, obesity, and diabetes.

The FDA’s decision was supported by findings from a Phase IIIb trial (NCT06389487), which demonstrated a non-inferior immune response compared with adults aged 60 years and older. Vaccine efficacy had previously been demonstrated in an earlier Phase III trial (NCT04886596). The safety profile remained consistent with results from the broader Phase III programme that supported the vaccine’s initial approval in the US. The most commonly reported adverse events included injection site pain, fatigue, myalgia, headache, and arthralgia within four days following vaccination.

GSK is also progressing with regulatory submissions for its RSV vaccine in several geographies, aiming to broaden availability and support its long-term growth strategy.