FDA Expands Respiratory syncytial virus vaccine Age Indication

The United States United States===Food and Drug Administration has expanded the approved age indication for GSK plc's respiratory syncytial virus (RSV) vaccine, Respiratory syncytial virus vaccine, to include adults aged 18 to 49 who are at increased risk for lower respiratory tract disease. Previously, Respiratory syncytial virus vaccine was approved for adults aged 60 and older, and those aged 50 to 59 with increased risk. This decision is supported by late-stage trial results demonstrating a non-inferior immune response in the younger cohort compared to adults over 60, with a consistent safety profile. GSK plc estimates that 21 million adults under 50 in the United States have at least one risk factor for severe RSV infection, representing a substantial new market. The company is also advancing regulatory submissions in other geographies to expand availability and support long-term growth. This move positions Respiratory syncytial virus vaccine to compete with Moderna's mRESVIA and Pfizer's Abrysvo in this broader age group, pending a recommendation from the United States United States===Centers for Disease Control and Prevention.