EU Medicines Agency Panel Recommends Booster Dose of GSK's Bexsero

MT Newswires · 1d ago
02:50 AM EST, 11/13/2026 (MT Newswires) -- GSK (GSK.L) received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use on an update to the product label of Bexsero. The recommendation allows a single booster dose for individuals aged 10 years and older who previously received the vaccine at least two years earlier, the UK-listed drugmaker said Friday. The positive opinion was supported by results from the phase 3b Men-B-096 study, which evaluated the immune response and safety of a single booster dose of Bexsero in healthy individuals aged 10 to 20 years who had previously completed the primary vaccination series. The study met its primary endpoint, and the safety and reactogenicity of a single booster dose were consistent with Bexsero's known safety profile in this age group.