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GSK plc, a global biopharma company, announced 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 behaviours 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-centre 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.
Invasive meningococcal disease (IMD) is a rare, life-threatening disease caused by Neisseria meningitidis that can progress rapidly and has a fatality rate of 4–20%. Up to 20% of IMD survivors have severe, life-changing sequelae, and the physical and psychological consequences of IMD can substantially impact quality of life. In 2024 in the European Union/European Economic Area, 56% of confirmed cases of IMD were due to serogroup B in all age groups under 65 years. The notification rate for IMD was highest among young children less than 1 year old (6.3 cases per 100 000), followed by children aged 1–4 years (1.38 confirmed cases per 100 000) and third highest in adolescents and young adults aged 15–24 years (0.83 per 100 000).
Bexsero is registered in 61 countries for the prevention of Invasive Meningococcal Disease (IMD) caused by Neisseria meningitidis serogroup B. In Europe, it is included in 15 national and/or regional immunisation programmes for infants, and 3 national immunisation programmes for adolescents. Around 138 million doses of Bexsero have been distributed globally since 2015.
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.
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