GSK Secures Positive CHMP Opinion for Single-Dose Bexsero Booster

GSK announced on November 13, 2026, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending an update to the marketing authorisation of Bexsero (4CMenB). The proposed label extension would include a single booster dose for individuals aged 10 years and older who previously received Bexsero at least two years earlier.

The recommendation is supported by findings from the Men-B-096 Phase IIIb study, indicating that immune memory established following primary vaccination during infancy can be boosted with a single dose up to 19 years later. The proposed strategy could maintain protection during adolescence, when invasive meningococcal disease (IMD) incidence experiences a second peak.

Phase IIIb Men-B-096 Study Meets Primary Endpoint

The CHMP recommendation is based on Men-B-096 (NCT06995430), a Phase IIIb, randomised, open-label, multicentre study evaluating the immunogenicity and safety of a single Bexsero booster dose in healthy individuals aged 10–20 years.

The study enrolled 312 participants across Finland, Italy, Spain and the United Kingdom. Among them, 234 had received Bexsero during infancy, while 78 had not previously received a meningococcal B vaccine.

Previously vaccinated participants received one booster dose, whereas participants without prior MenB vaccination received two doses, administered on Day 1 and Day 31. The primary endpoint assessed the superiority of the immune response in previously vaccinated participants compared with the response following the first dose in vaccine-naïve adolescents.

The primary immunogenicity assessment included human serum bactericidal assay (hSBA) titres, expressed as geometric mean titres (GMTs), against MenB indicator strains, alongside between-group GMT ratios at Day 31. The study met its primary endpoint, supporting the ability of a single booster dose to recall immune responses established through infant vaccination.

The clinical trial registry also confirmed the immunogenicity outcomes and safety assessments, including antibody responses against individual MenB indicator strains, solicited adverse events, serious adverse events and adverse events leading to study withdrawal.

The findings were also presented by investigators at the International Pathogenic Neisseria Conference (IPNC), held in Busselton, Western Australia, from September 13–17, 2026 (Abstract 141317).

Safety and Reactogenicity Findings

GSK reported that the safety and reactogenicity profile of a single Bexsero booster dose was consistent with the vaccine’s established safety profile in this age group.

The trial’s registered safety assessments included injection-site reactions, systemic events, unsolicited adverse events, serious adverse events and arthritis as an adverse event of special interest. These outcomes provide additional context for evaluating booster-dose tolerability alongside immunogenicity findings.

Regulatory Outlook and Vaccine Background

The positive CHMP opinion represents a step towards extending the Bexsero label to include a single booster dose for individuals aged 10 years and older who received their previous Bexsero vaccination at least two years earlier. The recommendation remains subject to the subsequent European regulatory process and does not itself constitute final approval of the proposed label extension.

Bexsero is registered in 61 countries for the prevention of IMD caused by Neisseria meningitidis serogroup B. Approximately 140 million doses have been distributed globally since 2015. In Europe, the vaccine is included in 15 national or regional infant immunisation programmes and three national adolescent immunisation programmes.

IMD is an uncommon but serious infection that can present as meningitis and/or septicaemia. Although incidence is highest among infants and young children, a second peak occurs in adolescents and young adults. Serogroup B is the leading cause of IMD in Europe among individuals younger than 65 years.

Clinical Significance

The positive CHMP opinion supports a potential single-dose booster strategy for individuals previously vaccinated against MenB during infancy. The Men-B-096 findings are particularly relevant because they demonstrate that immune memory established during early childhood can still be recalled many years later.

If approved, the proposed strategy could provide an additional vaccination opportunity during adolescence without requiring a new primary vaccination course in previously immunised individuals.

However, the study’s immunogenicity findings should not be interpreted as direct evidence of clinical effectiveness against IMD or continuous protective antibody levels throughout the interval following infant vaccination. The magnitude of the antibody response, its persistence after boosting and its relationship with clinical protection remain important considerations when evaluating the potential public-health benefit.

References

Bexsero (4CMenB) receives positive CHMP opinion for one-dose Meningitis B booster for 10+ year olds, GSK 13 November 2026

A Phase 3 Study to Assess the Immune Response and Safety of rMenB+OMV NZ in Primed Healthy Participants (10 to 20 Years Old), ClinicalTrials.gov ID NCT06995430

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. Presented at IPNC 2026, Abstract 141317.