UK—The European Commission (EC) has approved a new, fully liquid version of GSK’s Menveo vaccine (MenACWY), designed to protect against invasive meningococcal disease (IMD).
This new formulation, which does not require reconstitution before use, is a significant development in simplifying vaccination for individuals at risk of IMD, which is caused by bacterial serogroups A, C, W, and Y.
This comes a few weeks after GSK received approval from Japan’s Ministry of Health, Labour and Welfare to extend the use of its respiratory syncytial virus (RSV) vaccine, Arexvy, to individuals aged 50 to 59 who are at increased risk.
The new Menveo vaccine is licensed for use in children aged two years and older, adolescents, and adults.
It eliminates the need for mixing, which was necessary with the previous version of the vaccine.
This approval follows positive results from two Phase IIb clinical trials, which showed that the fully liquid formulation of Menveo offers similar levels of safety and effectiveness as the existing lyophilised or liquid formulations.
The trials also confirmed the vaccine’s tolerability, providing confidence in its use across a wide age range.
GSK’s Global Head of Vaccines Research and Development, Philip Dormitzer, expressed the company’s dedication to improving vaccination accessibility and uptake.
He emphasized GSK’s commitment to protecting individuals from the serious complications of bacterial meningitis, particularly among at-risk populations in the European Union.
Dormitzer also highlighted GSK’s ongoing efforts to innovate and simplify immunization processes, making it easier for people to receive life-saving vaccines.
The new approval does not affect the original version of the Menveo vaccine, which was approved by the European Medicines Agency (EMA) in 2010 and still requires reconstitution.
GSK has ensured that both formulations remain available, offering flexibility in vaccination options.
The MenACWY vaccine has a well-established safety profile and is already approved in over 60 countries.
Since its launch, more than 82 million doses of Menveo have been distributed globally, with more than six million doses delivered to European nations since 2017.
Invasive meningococcal disease is a serious, sometimes fatal, illness that can lead to complications such as brain damage or death, with babies and young adults particularly vulnerable.
Vaccination remains one of the most effective ways to prevent this deadly disease.
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