GSK's RSV shot cleared in US for all adults
Graphical representation of RSV.
GSK is back on level pegging with its rivals in the respiratory syncytial virus (RSV) vaccine category in the US, after getting FDA approval for the 18 to 49 age bracket.
The US regulator has cleared its Arexvy RSV shot for adults in that age group who are at increased risk of lower respiratory tract disease caused by the virus, having previously been cleared for the prevention of RSV-related disease in adults aged 60 and above, and in at-risk adults aged 50 to 59.
Arexvy is competing in the RSV vaccine market with Pfizer's Abrysvo and Moderna's mResvia, and recorded sales of £593 million ($785 million) last year, with sales doubling in Europe, but falling around 40% in the US due to restrictive changes in vaccination recommendations and a harder-to-activate patient cohort, which has cut into its market share.
Abrysvo was approved by the FDA for the over-18 age category in 2024, helping it reach 2025 sales of just over $1 billion. mResvia, meanwhile, was also cleared for this expanded population last year, but has struggled to make headway in the market, with sales of $8 million last year, down from $25 million in 2024.
All three vaccines have had their US sales potential curtailed by a decision by the CDC to recommend RSV jabs only for adults aged 75 and older, or those aged 50 to 74 who are at increased risk for severe RSV.
According to GSK, an estimated 21 million adults under 50 have at least one risk factor for severe RSV infection. Arexvy was also recommended for approval in the EU for at-risk 18 to 49-year-olds last December.
The annual RSV burden among US adults aged 18–49 years is about 17,000 hospitalisations, 277,000 emergency department admissions, and 1.97 million outpatient visits, said the company, citing figures from a 2022 study presented at the Open Forum of Infectious Diseases.
"This age expansion can help address a significant medical need for adults in the US at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system," said Sanjay Gurunathan, GSK's head of vaccines and infectious diseases R&D.
While serious disease in younger adults is rare, the risk is increased by underlying chronic conditions, such as obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease, and asthma.
