EC Approves GSK's Menveo Vaccine for Meningococcal Disease

GSK's meningococcal vaccine Menveo, now available in a fully liquid form, has received approval from the European Commission (EC) for use in individuals aged two years and older to guard against invasive meningococcal disease (IMD). This new single-vial presentation aims to streamline the vaccination process by eliminating the need for reconstitution before administration.

IMD is a rare but severe condition caused by the bacterium Neisseria meningitidis. It predominantly leads to meningitis and septicaemia, with potential long-term effects including neurological damage, amputations, hearing loss, and other nervous system complications. While anyone can be affected by IMD, the highest-risk groups include infants, young children, teenagers, and young adults.

Menveo targets IMD caused by the bacterial groups A, C, W, and Y. Previously, it was available in the EU as a powder and solution that had to be mixed before injection. The new, fully liquid version simplifies this process. The EC's approval of this presentation follows a recommendation from the European Medicines Agency’s human medicines committee. It is backed by positive results from two phase 2b trials, which demonstrated that the new liquid form had similar immunogenicity, tolerability, and safety profiles compared to the original formulation.

The initial version of Menveo, which is also approved for use in individuals aged two years and older, remains unaffected by this new approval. Philip Dormitzer, head of global vaccines research and development at GSK, emphasized the company's commitment to innovation in immunization and vaccine uptake. He stated that GSK is dedicated to protecting individuals from bacterial meningitis and will continue to work towards preventing this serious disease in at-risk populations within the EU.

In addition to Menveo, GSK is developing a five-in-one meningococcal vaccine that combines the components of Menveo with those of Bexsero, a vaccine approved for meningococcal group B. This investigational vaccine, known as MenABCWY, was accepted for regulatory review by the US Food and Drug Administration in April, following successful phase 3 trial results in individuals aged ten to 25 years.