EMA Accepts GSK's Submission for Single-Dose Bexsero Booster in Adolescents and Young Adults
核心洞察
GSK announced the EMA has accepted a submission to update the Bexsero label to include a single-dose booster for individuals aged 10 years and older previously vaccinated in infancy.
The submission is supported by Phase 3b clinical data showing a single booster dose effectively boosted immune responses in 10- to 20-year-olds who completed their primary series as infants.
If approved, the booster could help reduce the burden of invasive meningococcal disease (搜索) in countries with established infant MenB immunization programs.
GSK plc announced on 20 July 2026 that the European Medicines Agency (搜索) (EMA) has accepted a submission to update the label for Bexsero, the company's meningococcal serogroup B vaccine, to include a single-dose booster for individuals aged 10 years and older who were previously vaccinated with Bexsero during infancy. If approved, the label update would represent the first one-dose booster indication for this population, potentially extending protection against invasive meningococcal disease (搜索) (IMD) into adolescence and young adulthood.
The regulatory submission is supported by a Phase 3b, open-label, multi-centre study that evaluated the immune response of a Bexsero booster dose in individuals aged 10 to 20 years who received the complete primary vaccination series during infancy. According to GSK, the data demonstrate that a single dose was effective in boosting immune responses in this cohort. Full results from the study will be presented at the 25th International Pathogenic Neisseria Conference (IPNC) in September 2026.
Addressing a Persistent Public Health Challenge
Invasive meningococcal disease (搜索), caused by Neisseria meningitidis (搜索), remains an uncommon but severe illness with a case fatality rate ranging from 4% to 20%. Up to 20% of survivors experience severe, life-changing sequelae, and the physical and psychological consequences of IMD can substantially impact quality of life. While the highest incidence of IMD occurs in infants and young children, a second peak is observed among adolescents and young adults aged 15 to 24 years, often linked to behaviours that increase transmission, such as close contact through kissing, sharing drinks, and living in shared accommodation.
In 2024, within the European Union and European Economic Area, 56% of confirmed IMD cases across all age groups under 65 years were attributable to serogroup B. The notification rate was highest among infants less than one year old at 6.3 cases per 100,000, followed by children aged 1 to 4 years at 1.38 per 100,000, and adolescents and young adults aged 15 to 24 years at 0.83 per 100,000.
Bexsero's Global Footprint and Programmatic Implications
Bexsero is currently registered in 61 countries for the prevention of IMD caused by Neisseria meningitidis (搜索) serogroup B. In Europe, the vaccine is included in 15 national and/or regional immunisation programmes for infants and three national immunisation programmes for adolescents. Approximately 138 million doses of Bexsero have been distributed globally since 2015.
If the one-dose booster is approved, individuals vaccinated with Bexsero in childhood could receive a single booster dose at age 10 years or older. GSK stated that, if adopted, such a booster strategy could help reduce the overall burden of IMD in countries with established infant MenB programmes, providing a streamlined approach to maintaining protection during the adolescent risk window.
The EMA's acceptance of the submission marks the beginning of the regulatory review process. No timeline for a decision has been publicly disclosed.