The Investor
13 Mar 2026, 14:37
GSK announced that the U.S. Food and Drug Administration has expanded approval of its RSV vaccine, Arexvy, to adults aged 18–49 who are at increased risk of severe respiratory disease.
The vaccine was previously approved for adults aged 60 and older and for adults aged 50–59 with certain risk factors. The expanded indication addresses a significant population, with an estimated 21 million adults under 50 in the U.S. having at least one condition that increases the risk of severe RSV infection.
The FDA decision was supported by Phase III trial data showing immune responses in adults aged 18–49 were comparable to those in older adults. GSK said the approval supports its strategy to broaden RSV prevention across wider adult populations and reduce the burden of the disease on healthcare systems.
The vaccine was previously approved for adults aged 60 and older and for adults aged 50–59 with certain risk factors. The expanded indication addresses a significant population, with an estimated 21 million adults under 50 in the U.S. having at least one condition that increases the risk of severe RSV infection.
The FDA decision was supported by Phase III trial data showing immune responses in adults aged 18–49 were comparable to those in older adults. GSK said the approval supports its strategy to broaden RSV prevention across wider adult populations and reduce the burden of the disease on healthcare systems.
