U.S. regulators have expanded the approval for GlaxoSmithKline’s vaccine against respiratory syncytial virus (RSV), the company said March 13.
Adults as young as 18 can now receive the vaccine, provided they are at increased risk of lower respiratory tract disease caused by RSV because of having conditions such as chronic liver disease or compromised immune systems.
“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, GSK’s head of vaccines, said in a statement. ”We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations.”
Previously, the vaccine, Arexvy, was approved for adults aged 50 to 59 at increased risk of lower respiratory tract disease from RSV and all adults aged 60 and older.
The FDA did not return a request for comment by publication time.
Two competing vaccines, from Moderna and Pfizer, have already been cleared for adults as young as 18 who are deemed at increased risk of lower respiratory tract disease from RSV, although the Centers for Disease Control and Prevention only recommends RSV vaccination for adults aged 50 to 74 at increased risk of severe RSV, in addition to all adults aged at least 75.
RSV is a respiratory virus that typically causes mild symptoms such as a cold and cough, but can also cause severe illness. From Oct. 1, 2025, through Feb. 28, 2026, the CDC estimates RSV has led to 1.6 million outpatient visits, at least 94,000 hospitalizations, and at least 5,300 deaths.
As of mid-February, about 43 percent of adults aged 75 and older and about 33 percent of adults aged 50 to 74 with a high-risk condition had received an RSV shot at least once, according to the CDC’s RSV vaccination network. The CDC does not track how many 18 to 50-year-olds have received the vaccine.
RSV vaccination is also recommended for pregnant women and infants.
A colorized scanning electron micrograph shows human respiratory syncytial virus (RSV) virions shedding from human lung epithelial cells. (NIAID via The Epoch Times)
Sales of both Arexvy and Pfizer’s RSV vaccine fell in 2025, the companies reported. GSK reported a 40 percent decline, the steepest among all vaccines.
Moderna has not made detailed 2025 financial results available.
The expanded approval for Arexvy was based on a phase 3 open-label clinical trial that compared the immunogenicity of GSK’s vaccine in younger adults and older adults.
The trial showed that younger adults experienced an immune response no worse than the immune response recorded in older adults, according to GSK. The company said the trial also showed that the safety profile was consistent with previous findings, including that the most common adverse events were fatigue, headache, injection-site pain, muscle pain, and joint pain.
Suspected and confirmed side effects of the vaccine include fatigue and the immune system disorder Guillain-Barré Syndrome, according to the vaccine’s label.
