The European Commission (EC) has granted approval for a single-vial, fully liquid presentation of GSK's Menveo vaccine (MenACWY), designed to protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y.
The new presentation is licensed for use in children from two years of age, adolescents and adults, and removes the need for reconstitution prior to its use.
The EC's decision is based on the results of two positive Phase IIb trials, which demonstrated that the fully liquid formulation of Menveo has comparable immunogenicity and safety profiles to the current lyophilised or liquid formulation.
The trials' primary and secondary outcomes, backed by post-hoc pooled analyses, confirmed the vaccine's tolerability.
GSK global vaccines research and development head Philip Dormitzer stated: “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 original Menveo presentation, which required reconstitution and was approved by the European Medicines Agency (EMA) in 2010, remains unaffected by this new marketing authorisation.
Approved in more than 60 countries, the MenACWY vaccine has a well-characterised safety profile. The European Union approves it for active immunisation to prevent IMD in children from two years of age, adolescents, and adult population.
More than 82 million doses of the vaccine have been distributed globally since 2010, with more than six million doses supplied to European nations since 2017.
IMD is a serious illness that can lead to fatal complications. Groups at higher risk include babies, young children and young adults.
The company recently reported approval from Japan's Ministry of Health, Labour and Welfare to extend the indication of its respiratory syncytial virus vaccine, Arexvy, to individuals aged 50 to 59 at increased risk.
