GSK Bexsero: EMA accepts submission to add single-dose booster for 10+ years
- EMA has accepted GSK’s submission to update the Bexsero label to include a one‑dose booster for individuals aged 10 years and older previously vaccinated with Bexsero.
- The submission is supported by a Phase 3b, open‑label, multi‑centre study in 10–20 year olds showing a single dose effectively boosted immune responses.
- Full data from the study are scheduled for presentation at the 25th International Pathogenic Neisseria Conference (IPNC) in September.
- Bexsero is registered in 61 countries and about 138 million doses were distributed globally from 2015 to October 2025.
Regulatory update
The European Medicines Agency has accepted a submission to update the Bexsero label to include a single‑dose booster for individuals aged 10 years and older who were previously vaccinated with Bexsero in infancy.
Clinical support
The submission is supported by a Phase 3b, open‑label, multi‑centre study that evaluated immune responses to a Bexsero booster in participants aged 10–20 years who completed the primary infant series. Results show a single dose was effective in boosting immune responses in those vaccinated as infants; full data will be presented at the 25th IPNC in September.
Disease burden context
Invasive meningococcal disease (IMD) is rare but can be severe, with reported case fatality rates of 4–20% and up to 20% of survivors experiencing severe sequelae. In the EU/EEA in 2024, serogroup B accounted for 56% of confirmed IMD cases in people under 65, with the highest notification rates in infants and a third peak among 15–24 year olds.
Product footprint
Bexsero is registered in 61 countries and is included in multiple infant and adolescent immunisation programmes in Europe; approximately 138 million doses were shipped globally from 2015 to October 2025.
Source: GSK
