GSK's Menveo meningococcal vaccine in new liquid form gets positive EU CHMP opinion

GSK plc has announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a single-vial, fully liquid presentation of Menveo, a MenACWY vaccine. This new formulation aims to protect against invasive meningococcal disease (IMD) caused by bacterial groups A, C, W, and Y. If approved, the new presentation will be licensed for the active immunisation of children from 2 years of age, as well as adolescents and adults. This advancement provides healthcare providers with an option that does not require reconstitution before use, simplifying the vaccination process.

Philip Dormitzer, GSK's Head of Global Vaccines Research & Development, highlighted the company's commitment to innovative vaccine solutions: "As a global leader in meningococcal vaccines, we are 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." Dormitzer emphasized the ongoing efforts to prevent IMD in at-risk populations within the European Union.

The submission to the EMA is based on two positive Phase IIb clinical trials which demonstrated that the fully liquid formulation of Menveo has comparable immunogenicity, tolerability, and safety profiles to the existing lyophilized/liquid formulation. The trials' outcomes were supported by post-hoc pooled analyses. This recommendation by the CHMP is one of the final steps before the potential extension of the marketing authorisation by the European Commission (EC), which is expected to make a final decision by November 2024.

IMD is a severe and unpredictable illness that can lead to life-threatening complications. Despite treatment, one in six individuals who contract the disease may die, sometimes within 24 hours. Additionally, one in five survivors may suffer from long-term consequences such as brain damage, amputations, hearing loss, and nervous system issues. Babies, young children, and those in their late teens and early adulthood are among the most at-risk groups.

The original Menveo presentation, which requires reconstitution and was approved by the EMA in 2010, remains unaffected by this new recommendation.

Menveo has received regulatory approval in over 60 countries and more than 82 million doses have been distributed worldwide since 2010. Since 2017, over 6 million doses have been distributed to European countries. The vaccine has shown evidence of immunogenicity and has a well-characterised safety profile. In the European Union, Menveo is approved for active immunisation to prevent IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in individuals aged 2 years and older.

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