GSK plc (GSK, GSK.L) has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a single-vial, fully liquid presentation of Menveo. This vaccine is designed to protect against invasive meningococcal disease caused by bacterial groups A, C, W, and Y. According to the company, this positive opinion is one of the last steps before the European Commission potentially extends the marketing authorization. A final decision is anticipated by November 2024.
If the single-vial presentation receives approval, it will be licensed for active immunization in children aged 2 years and above, as well as in adolescents and adults. The MenACWY vaccine has already secured regulatory approval in over 60 countries, with more than 82 million doses distributed globally since its introduction in 2010.