GlaxoSmithKline (GSK) plc has reported that the European Commission (EC) has given its approval for a new, single-vial liquid version of Menveo, a Meningococcal Group A, C, W-135, and Y conjugate vaccine (MenACWY vaccine). This innovation provides protection against invasive meningococcal disease (IMD) linked to the bacterial serogroups A, C, W, and Y.
This newly approved presentation allows for active immunisation of children aged two years and older, as well as adolescents and adults. Significantly, it streamlines the vaccination process for healthcare professionals by eliminating the need for reconstitution before use.
Philip Dormitzer, who leads GSK’s global vaccines research and development, commented: “As leading innovators in the field of meningococcal vaccines, GSK is committed to advancing immunisation strategies that boost vaccine accessibility and uptake. We pledge to continue safeguarding at-risk communities in the European Union from bacterial meningitis.”
This approval follows GSK’s submission to the EC, which was supported by two successful phase IIb trials (2017-003692-61; 2017-003456-23). The trials demonstrated that the fully liquid format maintains comparable immunogenicity, tolerability, and safety standards in line with the previously marketed lyophilised/liquid version.
IMD stands out as an unpredictable yet acute disorder capable of leading to life-threatening scenarios. Even with treatment, as many as one in six affected individuals may succumb to the disease, sometimes within 24 hours. Additionally, 20% of survivors could experience long-term aftereffects such as neurological impairment, amputations, hearing loss, and issues with the nervous system. While anyone can contract IMD, infants, young children, and individuals in their late teens to early adulthood are most at risk.
The initial Menveo version, which necessitates reconstitution and was sanctioned by the EMA in 2010, remains unaffected by this recent endorsement.
GSK’s MenACWY vaccine boasts regulatory clearance in more than 60 countries, offering strong evidence of efficacy paired with a well-documented safety profile. Within the European Union, this vaccine is authorised for active immunisation to counter IMD attributable to Neisseria meningitidis serogroups A, C, Y, and W in eligible children, adolescents, and adults.
As a leading global biopharma entity, GSK strives to integrate science, technology, and expertise to proactively combat disease and improve health outcomes for all.