GSK's RSV Vaccine Arexvy Receives FDA Approval for At-Risk Younger Adult Population

FDA Expands Approval of GSK's Arexvy RSV Vaccine for Younger High-Risk Adults

GSK plc has received approval from the U.S. Food and Drug Administration (FDA) to broaden the use of its adjuvanted recombinant RSV vaccine, Arexvy. The vaccine can now be administered to adults aged 18 to 49 who are at increased risk of developing lower respiratory tract disease (LRTD) due to RSV infection.

Previously, Arexvy was authorized in the United States for individuals aged 60 and older, as well as for high-risk adults between 50 and 59 years old, to prevent RSV-related LRTD.

So far this year, GSK’s stock has climbed 8.8%, outpacing the 2.7% growth seen in the broader medical and genetics industry.

The FDA’s expanded approval was based on results from a late-stage clinical trial, which showed that Arexvy generated an immune response in adults aged 18 to 49 that was similar to that observed in those 60 and older. The vaccine’s safety and effectiveness remained consistent with earlier studies.

In January, the European Commission also authorized the wider use of Arexvy for all adults 18 and older to protect against RSV-related LRTD. Previously, European approval was limited to those 60 and above and high-risk individuals aged 50 to 59.

In China, the Center for Drug Evaluation is currently reviewing GSK’s application to approve Arexvy for adults aged 60 and above. If granted, Arexvy would be the first RSV vaccine available in China for this age group, with a decision expected in 2027.

Competing RSV Vaccines in the Market

With the recent FDA approval for younger adults, GSK’s Arexvy joins Pfizer’s Abrysvo and Moderna’s mResvia as the third RSV vaccine cleared for this age group in the United States.

• Pfizer’s Abrysvo is approved to prevent RSV-related LRTD in adults 60 and older. It is also authorized for use during pregnancy, providing protection to infants from birth through six months via maternal immunization. Currently, Abrysvo is the only RSV vaccine approved for use in pregnant individuals to safeguard newborns.
• Abrysvo is also approved in the U.S. and Europe for high-risk adults aged 18 to 59.
• Moderna’s mResvia has received approval from both the FDA and European Commission for use in adults 60 and older. In June 2025, the FDA extended its approval to include high-risk adults between 18 and 59 years old.

Arexvy’s Global Sales in 2025

In 2025, Arexvy achieved worldwide sales of £0.6 billion, reflecting a 2% increase at constant exchange rates. Growth was driven by strong demand outside the United States, particularly in markets like Germany, Canada, and Spain, where favorable recommendations and reimbursement policies supported uptake. However, sales in the U.S. declined due to slower adoption among the 60-plus population and reduced market share.

GSK’s Current Zacks Rank

GSK currently holds a Zacks Rank #3 (Hold).