Published by Global Banking & Finance Review®
Posted on July 14, 2025
2 min readLast updated: January 22, 2026
Add as preferred source on GoogleGSK applies for FDA approval to expand its RSV vaccine use to adults under 50, aiming to compete with Moderna and Pfizer in the US.
(Reuters) -British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the use of its respiratory syncytial virus (RSV) vaccine to adults under the age of 50 at a higher risk of the disease.
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 mRESVIA and Pfizer's Abrysvo.
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.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Rashmi Aich)
GSK is seeking FDA approval to extend the use of its RSV vaccine, Arexvy, to adults under 60.
The vaccine is currently approved for adults aged 60 and above, and at-risk adults aged 50 to 59.
The FDA is expected to make a decision on the expanded use of Arexvy in the first half of 2026.
If approved, GSK's vaccine would compete with Moderna's mRESVIA and Pfizer's Abrysvo for the 18-49 age group.
RSV is a common respiratory virus that causes seasonal infections and is a leading cause of pneumonia and death in infants and older adults.
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