GSK said on Friday 13 November that a European Medicines Agency committee has recommended updating the label of its meningitis B vaccine, Bexsero, to include a single booster dose for people aged 10 and over who were vaccinated with Bexsero at least two years earlier. The London-listed drugmaker said the recommendation was based on data showing that immune memory established by vaccination in infancy can be boosted with a single dose up to 19 years later.

The recommendation comes from the Committee for Medicinal Products for Human Use, known as the CHMP. A positive opinion from the committee is a recommendation rather than an approval, and the booster can only be used once the label change is adopted. GSK said that, once approved, the single-dose booster could help vaccination programmes maintain protection into adolescence, when disease incidence reaches a second peak.

Sanjay Gurunathan, senior vice president for research and development in vaccines and infectious diseases at 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 in countries with established infant MenB programmes.”

The trial behind the recommendation

The CHMP's positive opinion is based on data from Men-B-096, a Phase IIIb open-label, multi-centre study that assessed the immune response and safety of a single booster dose of Bexsero in healthy people aged 10 to 20 who had previously completed their primary vaccination series with Bexsero. The study met its primary endpoint, and GSK said the safety and reactogenicity of a single booster dose was consistent with the known safety profile of Bexsero in this age group.

The study enrolled 312 participants across Finland, Italy, Spain and the UK, including 234 who had received Bexsero during infancy and 78 who had not previously received a meningococcal B vaccine. The primary endpoint 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 in the past. The European Medicines Agency had accepted GSK's submission to update the Bexsero label in July 2026.

Why adolescence matters

Invasive meningococcal disease is uncommon, but it can progress rapidly and become life-threatening, according to GSK. Disease incidence is highest in infants and young children, with a second peak in adolescents and young adults. GSK said adolescents are more likely to catch or pass on the bacteria because they often spend more time socialising, live closely with others, and may share personal items.

In Europe, serogroup B is the leading cause of invasive meningococcal disease in all age groups under 65, according to the European Centre for Disease Prevention and Control, cited by GSK. The infection, caused by the bacterium Neisseria meningitidis, can present as meningitis or septicaemia, or blood poisoning, and can result in death or long-term complications despite treatment.

Bexsero's reach

Bexsero is registered in 61 countries for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B. In Europe, it is included in 15 national or regional immunisation programmes for infants, and three national immunisation programmes for adolescents, with additional infant vaccination programmes funded at a regional level in some countries. GSK said around 140 million doses of Bexsero have been distributed globally since 2015.

For GSK, which is listed on the London Stock Exchange and the New York Stock Exchange, the recommendation opens the way to wider use of an established vaccine in adolescent immunisation programmes across Europe, if the European Commission adopts the label change. The company cautioned investors that forward-looking statements in its announcement are subject to risks and uncertainties that may cause actual results to differ materially from those projected.