GSK plc filed a Form 6-K on November 13, 2026, announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending a label update for Bexsero (4CMenB) to include a single booster dose for individuals aged 10 years and older who were previously vaccinated at least two years earlier.

Key Highlights

  • CHMP positive opinion: The EMA's CHMP recommended updating the Bexsero label to allow a single booster dose for individuals 10 years and older previously vaccinated at least two years earlier with Bexsero.
  • Study basis: The recommendation is supported by data from Men-B-096, a Phase IIIb open-label, multi-centre study enrolling 312 participants aged 10-20 years across Finland, Italy, Spain, and the UK.
  • Immune memory finding: Data showed that immune memory established following primary vaccination in infancy can be boosted with a single dose up to 19 years later, according to the filing.
  • Study composition: Of the 312 participants, 234 had received Bexsero during infancy and 78 had not previously received a meningococcal B vaccine.
  • Global reach of Bexsero: The filing states Bexsero is registered in 61 countries and that approximately 140 million doses have been distributed globally since 2015.
  • European programmes: According to the filing, Bexsero is included in 15 national and/or regional immunisation programmes for infants and 3 national immunisation programmes for adolescents in Europe.

CHMP Recommends Bexsero Label Update Based on Phase IIIb Booster Study

GSK plc (LSE/NYSE:GSK) disclosed in its November 13, 2026 Form 6-K that the CHMP has recommended expanding the Bexsero label to cover a single booster dose for people aged 10 and older with prior Bexsero vaccination at least two years before. The company stated the opinion is intended to help vaccination programmes maintain protection into adolescence, a period when disease incidence reaches a second peak, according to the filing.

The recommendation is grounded in results from Men-B-096, described in the filing as a Phase IIIb, open-label, multi-centre study. The study assessed immune response and safety of a single booster dose in healthy individuals aged 10-20 years. The filing states the study met its primary endpoint, which was to assess the superiority of the immune response to a single booster dose in previously vaccinated participants compared with a first dose in adolescents who had not received a MenB vaccine previously. The filing also notes that "the safety and reactogenicity of a single booster dose is consistent with the known safety profile of Bexsero in this age group."

Sanjay Gurunathan, Senior Vice President, R&D Vaccines & Infectious Diseases, GSK, was quoted in the filing as saying the positive CHMP opinion "supports maintaining protection with a single booster dose during a second period in life of increased disease risk." The filing describes Invasive Meningococcal Disease (IMD) as an uncommon but serious infection caused by Neisseria meningitidis that can present as meningitis and/or septicaemia and may progress rapidly. The filing notes that in Europe, serogroup B is the leading cause of invasive meningococcal disease in all age groups under 65 years. GSK cautions that forward-looking statements in the announcement are subject to risks and uncertainties as described in its Annual Report on Form 20-F for 2025 and its Q3 Results for 2026.

What Was Disclosed

GSK plc reported a positive CHMP opinion recommending a Bexsero label update to include a single booster dose for individuals aged 10 and older with prior vaccination, supported by Phase IIIb study Men-B-096 data showing immune memory can be boosted up to 19 years after primary vaccination in infancy.