GSK recently announced that the European Medicines Agency (EMA) has accepted a submission to update the label for Bexsero to include a single-dose booster for individuals aged 10 years and older who were previously vaccinated with Bexsero.

If a one-dose booster is approved, those vaccinated with Bexsero in childhood could receive a single Bexsero dose at age 10 years or older. If adopted, a booster could help reduce the overall burden of Invasive Meningococcal Disease (IMD) in countries with established infant MenB programmes.

IMD is an uncommon but severe illness caused by Neisseria meningitidis. While the highest incidence is in infants and young children, there is also a peak in 15-24 year olds, often linked to behaviors that increase transmission, such as close contact through kissing, sharing drinks, and living in shared accommodation.

The submission is supported by a phase 3b, open-label, multi-center study that evaluated the immune response of a Bexsero booster dose in individuals 10 to 20 years old who received the complete primary series during infancy. The data show a single dose was effective in boosting the immune responses of individuals vaccinated as infants. Full data will be presented at the 25th International Pathogenic Neisseria Conference (IPNC) in September.