LONDON, United Kingdom, July 20, 2026
GSK plc has announced that the European Medicines Agency (EMA) has accepted its regulatory submission to update the Bexsero label to include a single-dose booster vaccination for individuals 10 years of age and older who were previously immunized with Bexsero during infancy. The proposed label expansion represents an important step toward strengthening long-term protection against Invasive Meningococcal Disease (IMD) caused by Neisseria meningitidis serogroup B (MenB). If approved by European regulators, the updated indication would allow adolescents and young adults who completed the infant vaccination schedule to receive a single booster dose, helping sustain immunity during an age when the risk of meningococcal transmission and disease increases. The regulatory milestone reinforces GSK’s ongoing commitment to expanding vaccine protection through evidence-based immunization strategies designed to reduce the burden of life-threatening infectious diseases.
EMA Submission Supported by Positive Phase IIIb Clinical Data
The regulatory application is supported by findings from a Phase IIIb, open-label, multicenter clinical study evaluating the immune response generated by a single Bexsero booster dose in individuals 10 to 20 years of age who completed the full primary vaccination series during infancy. Clinical data demonstrated that one booster dose successfully restored and strengthened immune responses against meningococcal serogroup B, supporting the potential for sustained protection years after initial childhood vaccination. The complete study results are scheduled to be presented at the 25th International Pathogenic Neisseria Conference (IPNC), providing additional scientific evidence supporting the proposed label update. If authorized by the EMA and adopted into national immunization programs, the booster strategy could become an important component of long-term meningococcal disease prevention across Europe.
Booster Strategy Addresses Ongoing Risk of Meningococcal Disease
Although Invasive Meningococcal Disease (IMD) remains relatively uncommon, it is one of the most serious bacterial infections due to its rapid progression and potentially devastating outcomes. The disease can develop within hours and carries a fatality rate ranging from 4% to 20%, while many survivors experience permanent neurological damage, hearing loss, limb amputations, or other lifelong complications. Although infants remain the highest-risk population, epidemiological data also identify a second peak of disease among adolescents and young adults aged 15 to 24 years, largely due to behaviors that facilitate bacterial transmission, including close social contact, shared accommodation, kissing, and sharing drinks. Across the European Union and European Economic Area, serogroup B remains the leading cause of invasive meningococcal disease among individuals under 65 years of age, highlighting the continued need for durable vaccine-induced protection beyond infancy.
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Bexsero Continues to Strengthen Global Vaccination Programs
Bexsero is currently approved in 61 countries for the prevention of MenB invasive meningococcal disease and has become a cornerstone of national vaccination strategies worldwide. Within Europe, the vaccine has been incorporated into numerous infant and adolescent immunization programs, with approximately 138 million doses distributed globally since its introduction. The latest EMA submission reflects GSK’s continued investment in expanding the clinical value of its vaccine portfolio by adapting immunization strategies to evolving public health needs. If approved, the new booster indication could help reinforce long-term protection against meningococcal disease, improve immunity during adolescence and early adulthood, and contribute to reducing severe infections, hospitalizations, and meningococcal-related deaths across populations at increased risk. The submission also strengthens GSK’s leadership in vaccine innovation and preventive healthcare through continued regulatory and clinical advancement.
Source: GSK press release
