GSK PLC on Wednesday said its meningitis vaccine, Menveo, has received approval from the European Commission in a new single-vial, fully liquid presentation.

In 2022, the London-based pharmaceutical firm released an updated formulation for Menveo that eliminated the need of a second dose for reconstruction, simplifying the immunisation process.

The single-dose vaccine is now licensed for active immunisation in the European Union for children from two years of age, as well as adolescents and adults, offering protection against meningococcal serogroups A, C, W, and Y.

The approval is supported by data from two Phase IIb trials, which demonstrated that the fully liquid Menveo formulation provides comparable immunogenicity, tolerability, and safety to the previous formulation.

The decision from the European Commission build on the positive opinion from the European Medicine Agency’s for Medicinal Products for Human Use regarding the new single-vial that the Brentford, London-based biopharmaceutical group, received in September.

Invasive meningococcal disease, known as meningitis, is an uncommon but serious illness that can cause life-threatening complications or even death. IMD is caused by neisseria meningitidis, with the majority of cases caused by serogroups A, B, C, W, Y in most of the world.

Head of Global Vaccines Research & Development Philip Dormitzer said: ‘As a leader in meningococcal vaccines, GSK is dedicated to finding innovative solutions that simplify immunisation and support vaccine uptake. We remain committed to safeguarding individuals from bacterial meningitis, and we will persist in our efforts to prevent this devastating disease among at-risk populations in the European Union.’

The European approval follows a similar milestone for Menveo in the United States. In late 2022, the US Food & Drug Administration approved the single-vial Menveo presentation for use in individuals aged 10 to 55.

Shares in GSK were up 0.3% at 1,341.50 pence each on Wednesday morning in London.

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