Menveo meningococcal vaccine receives positive European CHMP opinion

GSK announces that the EMA has recommended for use a single-vial, fully liquid presentation of Menveo to help protect against invasive meningococcal disease caused by bacterial groups A, C, W, and Y.

If Menevo receieves approval, this single-vial presentation will be licenced for active immunisation of children from 2 years of age, adolescents and adults, offering healthcare providers an option that does not require reconstitution before its use.

Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said: “As a global leader in meningococcal vaccines, we are committed to finding innovative solutions that simplify immunisation against bacterial meningitis, support vaccine uptake and help protect as many people as possible from this devastating disease. We will continue our efforts to help prevent this disease in at-risk populations in the European Union.”

GSK’s submission to the EMA is based on two positive Phase IIb trials. The primary and secondary outcomes of these trials, supported by post-hoc pooled analyses, show that the fully liquid formulation of this vaccine has comparable immunogenicity, tolerability and a comparable safety profile to the existing lyophilized/liquid formulation. Today’s positive opinion marks one of the final steps prior to the potential extension of the marketing authorisation by the European Commission.

 

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CHMP, EMA, GSK, GSK’s Menveo meningococcal, vaccine