The European Commission (EC) has approved a single-vial, fully liquid presentation of GSK’s Menveo vaccine for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W, and Y.
This new formulation of the MenACWY vaccine, designed for active immunisation in children aged two years and older, as well as adolescents and adults, eliminates the need for reconstitution prior to use.
According to GSK, the fully liquid presentation simplifies the vaccination process, making it more convenient for healthcare providers.
The approval is supported by two Phase IIb trials, which demonstrated that the fully liquid Menveo formulation has comparable immunogenicity, tolerability, and safety to the existing lyophilised/liquid version. Post-hoc pooled analyses further supported these findings.
GSK global vaccines research and development head 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.”
GSK confirmed that the original Menveo presentation, approved by the European Medicines Agency (EMA) in 2010, remains available and unaffected by this new authorisation.
MenACWY has received regulatory approval in over 60 countries. Within the European Union, it is authorised for use in preventing IMD caused by bacterial serogroups A, C, W, and Y in individuals two years of age and older.
Recently, GSK announced the expanded approval for its RSV vaccine, Arexvy, in Japan. The Ministry of Health, Labour and Welfare (MHLW) approved its use for adults aged 50–59 at increased risk of RSV disease, following an earlier approval in September 2023 for adults aged 60 and over.
