GSK has secured an FDA expansion for its respiratory syncytial virus vaccine, Arexvy, for adults ages 18 to 49 who are at increased risk of lower respiratory tract disease caused by the virus.
The green light puts GSK on a level playing field with Pfizer and Moderna, which secured endorsements for their RSV shots in 2025 and 2024, respectively. All three of the shots were originally approved for the prevention of RSV in adults 60 and older.
In June 2024, GSK gained FDA clearance for at-risk adults age 50 and older, with Pfizer achieving its larger at-risk age expansion four months later.
“This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system,” Sanjay Gurunathan, M.D., GSK’s vaccines R&D chief, said in a release.
Two months ago, Europe signed off on Arexvy’s use for all adults—regardless of their health status—in the same age group.
Roughly 17,000 people ages 18 to 49 are hospitalized for RSV in the U.S. each year, GSK said, with most of those affected having chronic medical conditions that place them at risk for severe RSV.
The new GSK endorsement comes amid a pressurized vaccine environment in the U.S. In December, the Centers for Disease Control and Prevention (CDC) upended the immunization schedule for children in the U.S., chopping six shots that were previously recommended.
Additionally, immunization against RSV—which is the top cause for infant hospitalizations in the U.S., according to the CDC—is now limited to those at high risk and children whose mothers have not been vaccinated.
In Arexvy’s first year on the market in 2023, GSK reported worldwide sales of 1.2 billion pounds ($1.49 billion), followed by a decline to 593 million pounds ($757 million) in 2024 and 590 million pounds ($777 million) last year. Meanwhile, sales of Pfizer’s Abrysvo increased from $755 million in 2024 to $1.03 billion last year.
