GSK plc (LON:GSK, NYSE: GSK) has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended updating the Bexsero label to include a single booster dose for individuals aged 10 years and older who were previously vaccinated at least two years earlier with Bexsero. The recommendation is supported by data showing that immune memory established following primary vaccination in infancy can be boosted with a single dose up to 19 years later1.
Sanjay Gurunathan, Senior Vice President, R&D Vaccines & Infectious Diseases, GSK, said: “As the first generation of children vaccinated against MenB in infancy reaches adolescence, today’s positive CHMP opinion supports maintaining protection with a single booster dose during a second period in life of increased disease risk. If adopted, adolescent boosters could help reduce the overall burden of Invasive Meningococcal Disease (IMD) in countries with established infant MenB programmes”.
While Invasive Meningococcal Disease (IMD) is uncommon, it can progress rapidly and become life-threatening3. Disease incidence is highest in infants and young children, with a second peak in adolescents and young adults2. Adolescents are more likely to catch or pass on these bacteria because they often spend more time socialising, live closely with others, and may share personal items4. In Europe, serogroup B is the leading cause of invasive meningococcal disease in all age groups under 65 years2.
The CHMP’s positive opinion is based on data from Men-B-096, a Phase IIIb open label, multi-centre study which assessed the immune response and safety of a single booster dose of Bexsero in healthy individuals aged 10-20 years who previously completed their primary vaccination series with Bexsero. The study met its primary endpoint. The safety and reactogenicity of a single booster dose is consistent with the known safety profile of Bexsero in this age group.
- Icardi G, Martinón-Torres F, Salamanca de la Cueva I, et al. A single adolescent dose of 4CMenB effectively boosts immune responses up to 19 years after priming in infancy: Results from a phase 3b, open-label, multicenter study. Presented at the International Pathogenic Neisseria Conference (IPNC), Busselton, Western Australia, Australia, 13-17 September 2026. Abstract 141317.
- European Centre for Disease Prevention and Control. Invasive meningococcal disease – Annual Epidemiological Report for 2024. Stockholm: ECDC; 2026. Accessed November 2026. https://www.ecdc.europa.eu/en/publications-data/invasive-meningococcal-disease-annual-epidemiological-report-2024
- European Centre for Disease Control and Prevention. Disease information about meningococcal disease, 28 November 2023. Available at: https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet. Accessed November 2026.
- Centers for Disease Control and Prevention. Risk Factors for Meningococcal Disease. Available at: https://www.cdc.gov/meningococcal/risk-factors/index.html. Accessed November 2026
