GSK seeks FDA nod for expanded use of RSV vaccine in adults
If approved in the world's biggest pharmaceuticals market, GSK's vaccine, Arexvy, would be competing for a market share in the 18-49 age group with Moderna's (MRNA.O), opens new tab mRESVIA and Pfizer's (PFE.N), opens new tabAbrysvo, opens new tab.
RSV is a common respiratory virus that causes seasonal infections such as the flu and is a leading cause of pneumonia and death in infants and older adults.
GSK's vaccine is currently approved in the U.S. for preventing RSV-related disease in adults aged 60 and above, and in at-risk adults aged 50 to 59. While it had a lead in approvals initially, it has since lagged behind rivals and sales have fallen sharply.
The FDA is expected to make a decision on the expanded use of Arexvy in the first half of 2026, GSK said. European regulators are also expected to rule on a similar application by then.
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