RegulatoryJul 20, 2026, 10:17 AM
GSK: EMA accepts Bexsero 1-dose booster submission for 10+ year olds
AI Summary
GSK announced that the European Medicines Agency (EMA) has accepted a submission to update the label for its vaccine, Bexsero. This update proposes including a single-dose booster for individuals aged 10 years and older who were previously vaccinated with Bexsero. If approved, this booster could enhance protection against Invasive Meningococcal Disease (IMD) and potentially reduce its burden in regions with existing infant MenB programs.
Key Highlights
- EMA accepted submission to update Bexsero label for 1-dose booster.
- Booster targets individuals aged 10 years and older previously vaccinated with Bexsero.
- If approved, it could help protect against Invasive Meningococcal Disease (IMD).
- Submission is supported by a Phase 3b study in 10-20 year olds.
- Full study data will be presented at the 25th IPNC in September.
- Bexsero is registered in 61 countries globally.
- Approximately 138 million doses of Bexsero have been distributed since 2015.
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