London, March 13, 2026, 13:11 GMT
- The U.S. FDA cleared an expanded label for GSK’s Arexvy, now greenlighting the RSV shot for adults 18 to 49 with higher risk profiles. 1
- GSK’s London shares rose roughly 1.1%, trading at about 2,054 pence, according to delayed Reuters data. 2
- Reuters said the shot can’t roll out to the newly eligible group just yet—it still awaits a CDC sign-off. 1
GSK shares climbed Friday after the U.S. FDA cleared a broader use for its RSV vaccine, Arexvy, now including at-risk adults aged 18 to 49. The London-listed stock gained roughly 1.1%, trading near 2,054 pence, Reuters reported. 1
This shift comes as GSK scrambles for new vaccine momentum at a time when that segment’s outlook has grown shakier. Just last month, the company warned investors that vaccine and general medicines revenue in 2026 might slip a bit or hold steady. Specialty medicines, by contrast, are still on track for stronger gains. 3
This move cracks open a bigger U.S. market. GSK points to roughly 21 million Americans under 50 carrying at least one risk factor for severe RSV infection. Reuters noted that Arexvy’s expanded label throws it into direct competition with Moderna’s mRESVIA and Pfizer’s Abrysvo for adults ages 18 to 49. 4
RSV, short for respiratory syncytial virus, crops up seasonally and poses a risk of pneumonia along with other serious infections, particularly in vulnerable adults. Arexvy had previously secured approval in the U.S. for adults 60 and up, as well as at-risk individuals between 50 and 59. 1
Sanjay Gurunathan, who leads vaccines and infectious diseases R&D at GSK, said expanding the age indication targets a “significant medical need” and should allow the company to reach more adults with RSV prevention. 4
GSK noted the FDA’s call leaned on late-stage trial data: immune response in adults 18 to 49 at risk matched that seen in patients 60 and up. Safety-wise, the company reported findings in line with earlier research—pain where the shot was given, fatigue, and headache led the list of usual side effects. 4
But approval alone doesn’t ensure Arexvy will see an immediate sales jump. Reuters noted the vaccine still awaits a formal nod from the U.S. Centers for Disease Control and Prevention before reaching the now-approved age group—a decision likely to influence both when it rolls out and how many actually get it. 1
Even after Friday’s uptick, the stock remains under its 52-week peak of 2,282 pence, according to Reuters market data. GSK shares surged over 5% on Feb. 4, following new chief executive Luke Miels’ endorsement of the company’s long-term sales target—his first outlook presentation drew a positive response from investors. 2
The RSV label win gives investors something to work with, though it doesn’t settle the bigger picture. GSK still faces the challenge of covering upcoming patent cliffs with new products and a string of smaller acquisitions. On Friday, the company said RSV filings are moving ahead in multiple markets. 3
