GSK (LSE:GSK) said the European Medicines Agency has accepted a submission to update the label for Bexsero, its meningitis B vaccine, to include a single booster dose for individuals aged 10 and older who received the vaccine previously.
If approved, those vaccinated with Bexsero in childhood could receive one additional dose from age 10, a change GSK said could help reduce the burden of invasive meningococcal disease in countries with established infant immunisation programmes.
The filing draws on a Phase 3b, open-label, multi-centre study of 10 to 20 year-olds who completed the full primary vaccination series as infants, which found a single booster dose was effective at raising their immune response.
Full results from that study will be presented at the 25th International Pathogenic Neisseria Conference in September.
News Intelligence what this means for the company
GSK's Bexsero meningitis B vaccine has cleared EMA acceptance for a label update permitting a single booster dose in people aged 10 and over who completed primary vaccination in infancy. The filing rests on Phase 3b data showing the booster raised immune response in 10–20 year-olds; full results will be presented in September. This is a routine regulatory step—acceptance does not guarantee approval—and expands the addressable population for an already-approved vaccine in markets with established infant immunisation programmes.
A booster label expansion for an established vaccine is incremental to GSK's portfolio. The commercial upside depends on adoption in countries with infant meningitis B programmes and regulatory approval; the filing acceptance itself is a procedural milestone, not a clinical or commercial inflection.
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