GSK’s vaccine Menveo has been recommended for approval in the European Union to provide protection against invasive meningococcal disease from bacterial groups A, C, W, and Y.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the nod for the single-vial, fully liquid formulation based on positive Phase IIb trials for the vaccine.

The studies (2017-003692-61 and 2017-003456-23) demonstrate that the vaccine's fully liquid formulation compares favorably to the current lyophilized/liquid formulation in terms of immunogenicity, tolerability, and safety profile.

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“As a global leader in meningococcal vaccines, we are committed to finding innovative solutions that simplify immunization against bacterial meningitis, support vaccine uptake, and help protect as many people as possible from this devastating disease,” stated Philip Dormitzer, GSK Head of Global Vaccines Research & Development.

This new Menveo vaccine does not require reconstitution and, once passed, will be licensed for active immunization in children aged 2 years and older, as well as in adolescents and adults, providing healthcare providers with an easy-to-use option.

The EC’s final decision is expected by November 2024.

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