# GSK secures positive EU recommendation for Bexsero Meningitis booster

- Link: https://www.directorstalkinterviews.com/gsk-secures-positive-eu-recommendation-for-bexsero-meningitis-booster/4121269689
- Published: 2026-11-13T07:05:00+00:00
- Author: Amilia Stone

**[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
[LON:GSK](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l),
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 later^(1).

> **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-threatening^(3). Disease incidence is highest in infants and young
children, with a second peak in adolescents and young adults^(2). 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 items^(4). In Europe,
serogroup B is the leading cause of invasive meningococcal disease in all age groups
under 65 years^(2).

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.

 1. 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.
 2. 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
 3. 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.
 4. 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

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