News | March 16, 2026
GSK expands RSV vaccine to younger adults in US, targeting high-risk 18–49 age group
Previously, Arexvy was authorized for adults 60 and older, and for those 50–59 with heightened risk
Previously, Arexvy was authorized for adults 60 and older, and for those 50–59 with heightened risk
The data highlights its RSV vaccine cuts hospitalizations in older adults
Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74
Decision on EU marketing authorisation for this population expected by September 2024
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials
Pfizer is likely to show GSK significant competition
Subscribe To Our Newsletter & Stay Updated
