CHMP Recommends GSK's Menveo Vaccine for Meningococcal Disease

GSK has received a recommendation from the European Medicines Agency’s human medicines committee for a new presentation of its meningococcal vaccine, Menveo. This innovative version comes as a single-vial, fully liquid form, making it easier for healthcare providers as it requires no reconstitution before use. It is intended for individuals aged two years and older.

Invasive meningococcal disease (IMD), an uncommon but severe illness caused by Neisseria meningitidis bacteria, is a significant cause of meningitis and septicaemia. Children and adolescents are particularly at high risk for this disease. GSK’s Menveo vaccine aims to protect against IMD caused by bacterial groups A, C, W, and Y. The vaccine is already approved in the European Union in a powder and solution form that needs to be mixed before injection.

The Committee for Medicinal Products for Human Use based its recommendation for the new liquid vaccine on positive findings from phase 2b trials. These trials demonstrated that the fully liquid form had immunogenicity, tolerability, and a safety profile comparable to the current formulation. This recommendation will now be reviewed by the European Commission, with a final decision expected by November.

Philip Dormitzer, GSK's head of global vaccines research and development, emphasized the company’s commitment to innovating solutions that simplify immunisation and support vaccine uptake. He stated, "We are dedicated 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." Dormitzer also mentioned that GSK would continue its efforts to prevent this disease in at-risk populations within the EU.

The original Menveo presentation, approved for individuals aged from two years, remains unaffected by this new recommendation. In addition to Menveo, GSK is developing a five-in-one meningococcal vaccine candidate called MenABCWY. This new vaccine combines the antigenic components of Menveo and GSK's approved meningococcal group B vaccine, Bexsero. The MenABCWY vaccine was accepted for regulatory review by the US Food and Drug Administration in April, with the application supported by results from a phase 3 trial involving individuals aged ten to 25 years. The aim is for this vaccine to offer the broadest possible protection against meningococcal disease, potentially leading to higher vaccine uptake.

In summary, GSK's new single-vial, fully liquid Menveo vaccine could significantly simplify the process for healthcare providers, increasing efficiency and potentially improving vaccination rates. This development represents a crucial step in protecting individuals, particularly those at high risk, from invasive meningococcal disease. The European Commission's forthcoming decision will determine the availability of this innovative vaccine option across the EU. Meanwhile, GSK continues to advance its broader vaccine pipeline with the MenABCWY candidate, aiming to provide comprehensive protection against multiple meningococcal strains.