GSK has received a recommendation from the European Medicines Agency’s human medicines committee for a single-vial, fully liquid presentation of its meningococcal vaccine Menveo.
The new presentation, which would be indicated for use in individuals aged two years and older, would offer healthcare providers an option that does not require reconstitution before use.
Invasive meningococcal disease (IMD) is an uncommon but serious illness caused by the bacterium Neisseria meningitidis. It is a major cause of meningitis and septicaemia, with children and adolescents among those at the highest risk.
GSK’s Menveo is designed to help protect IMD caused by bacterial groups A, C, W, and Y and is already approved in the EU as a powder and solution that are mixed together to make a solution for injection.
The Committee for Medicinal Products for Human Use’s new recommendation was supported by positive results from phase 2b trials, which showed that the fully liquid form of the vaccine had comparable immunogenicity, tolerability and a comparable safety profile to the existing formulation.
The European Commission will now take the committee’s positive opinion into account, with a final decision expected by November.
Philip Dormitzer, GSK head of global vaccines research and development, said the company is “committed 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”.
“We will continue our efforts to help prevent this disease in at-risk populations in the EU,” he added.
The original presentation of Menveo, which is also approved for use in individuals aged from two years, is unaffected by the recommendation
GSK also has a five-in-one meningococcal vaccine candidate, which combines the antigenic components of Menveo and its approved meningococcal group B vaccine Bexsero.
MenABCWY was accepted for regulatory review by the US Food and Drug Administration in April, with its application supported by results from a phase 3 trial involving individuals aged ten to 25 years.
It is hoped that the vaccine would provide the widest possible protection against the disease and lead to higher vaccine uptake.