GSK’s fully liquid presentation of its meningococcal vaccine Menveo has been approved by the European Commission (EC) to protect individuals aged two years and older against invasive meningococcal disease (IMD).
The single-vial presentation is designed to simplify the vaccination process by offering healthcare providers an option that does not require reconstitution before use.
IMD is an uncommon but serious illness caused by the bacterium Neisseria meningitidis. It is a major cause of meningitis and septicaemia, and can result in long-term consequences such as neurological damage, amputations, hearing loss and nervous system problems.
Although anyone can contract IMD, babies, young children and those who are in their late teens and early adulthood are among those at the highest risk.
Menveo is designed to help protect IMD caused by bacterial groups A, C, W, and Y and has already been approved in the EU as a powder and solution that are mixed together to make a solution for injection.
The EU regulator’s decision on the new presentation follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from two 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 original presentation of Menveo, which is also approved for use in individuals aged from two years, is unaffected by the approval.
Philip Dormitzer, head of global vaccines research and development at GSK said the company 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 EU,” he said.
GSK also has an investigational five-in-one meningococcal vaccine in its pipeline which combines the antigenic components of Menveo and its approved meningococcal group B vaccine Bexsero.
The candidate, MenABCWY, was accepted for regulatory review by the US Food and Drug Administration in April, following positive results from a phase 3 trial involving individuals aged ten to 25 years.