LONDON (dpa-AFX) - GSK plc (GSK) on Monday said the European Medicines Agency (EMA) has accepted a regulatory submission to update the label of its meningococcal B vaccine, Bexsero, to include a single booster dose for previously vaccinated individuals aged 10 years and older to help prevent Invasive Meningococcal Disease (IMD).
The submission is supported by data from a Phase 3b study showing that a single Bexsero dose successfully boosted immune responses in individuals aged 10 to 20 years who had received the primary vaccination series as infants.
IMD, caused by Neisseria meningitidis, is a rare but potentially life-threatening infection caused by Neisseria meningitidis and carries a fatality rate of 4% to 20%.
Bexsero is approved in 61 countries for the prevention of IMD caused by Neisseria meningitidis serogroup B. In Europe, the vaccine is included in 15 national or regional infant immunization programs and three national adolescent immunization programs.
GSK shares closed down 1.91% at $51.76 on Friday on the NYSE.
Copyright(c) 2026 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2026 AFX News
