GSK plc has announced that the U.S. Food and Drug Administration (FDA) has expanded the approved use of its respiratory syncytial virus (RSV) vaccine, Arexvy, to include adults aged 18 to 49 who are at increased risk for lower respiratory tract disease (LRTD) caused by RSV. The decision marks a significant step in broadening protection against RSV beyond older populations.
Arexvy was previously approved in the United States for adults aged 60 and above, as well as those aged 50 to 59 who are at elevated risk of RSV-related complications. With this latest approval, the vaccine can now be administered to a younger group of vulnerable adults, particularly those with underlying health conditions such as chronic heart or lung disease, kidney disorders, obesity, or diabetes. The vaccine, however, is not indicated for use in pregnant individuals.
According to GSK, the expansion addresses a considerable unmet medical need. RSV is often associated with infants and older adults, but it also places a substantial burden on younger at-risk populations. In the United States alone, RSV leads to approximately 17,000 hospitalizations, 277,000 emergency department visits, and nearly 2 million outpatient visits each year among adults aged 18 to 49. A large proportion of these severe cases occur in individuals with pre-existing medical conditions.
The FDA’s decision was supported by data from a Phase IIIb clinical trial, which demonstrated that the immune response generated by Arexvy in adults aged 18 to 49 was non-inferior to that observed in adults aged 60 and older. These findings build on earlier Phase III trial results that confirmed the vaccine’s efficacy in preventing RSV-related lower respiratory tract disease.
The safety profile of the vaccine in the younger adult population was consistent with previous studies. The most commonly reported side effects included injection site pain, fatigue, muscle aches, headache, and joint pain, typically occurring within a few days after vaccination.
Sanjay Gurunathan, Head of Vaccines and Infectious Diseases Research and Development at GSK, noted that the expanded indication could help reduce pressure on healthcare systems by preventing severe RSV cases in high-risk individuals. He emphasized that the move aligns with GSK’s broader strategy to extend RSV prevention to wider adult populations.
GSK also indicated that it is continuing to pursue regulatory approvals for Arexvy in other regions, aiming to increase global access to the vaccine while supporting its long-term growth strategy in infectious disease prevention.