• 25 Sep 2024
• Admin
• News Article

Ema’s Recommends Approval of GSK’ Menveo Meningococcal Vaccine

EMA’s human medicines committee recommends approval of GSK’s single-vial, fully liquid presentation of Menveo meningococcal vaccine

Overview

GSK plc announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial groups A, C, W, and Y.

Post Approval Scenario

If approved, this single-vial presentation will be licenced for active immunisation of children from 2 years of age, adolescents and adults, offering healthcare providers an option that does not require reconstitution before its use.

Statement from GSK

Philip Dormitzer, GSK head of global vaccines research & development, said: “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. We will continue our efforts to help prevent this disease in at-risk populations in the European Union.

Behind the Submission to the Ema

• GSK’s submission to the EMA is based on two positive phase IIb trials (2017-003692-61; 2017-003456-23). 
• The primary and secondary outcomes of these trials, supported by post-hoc pooled analyses, show that the fully liquid formulation of this vaccine has comparable immunogenicity, tolerability and a comparable safety profile to the existing lyophilized/liquid formulation. 
• Today’s positive opinion marks one of the final steps prior to the potential extension of the marketing authorisation by the European Commission (EC). 
• The EC’s final decision is expected by November 2024.

About Invasive Meningococcal Disease

• IMD is an unpredictable but serious illness that can cause life-threatening complications. 
• Despite treatment, among those who contract IMD one in six will die, sometimes in as little as 24 hours. 
• One in five survivors may suffer long-term consequences such as brain damage, amputations, hearing loss and nervous system problems. 
• Although anyone can get IMD, babies, young children and those who are in their late teens and early adulthood are amongst the groups at higher risk.
• The original presentation of Menveo that requires reconstitution and which was approved by the EMA in 2010 is unaffected by this recommendation.

GSK’s MenACWY Vaccine

• GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, with more than 82 million doses distributed worldwide since 2010. 
• Over 6 million doses have been distributed to European countries since 2017. 
• It offers evidence of immunogenicity with a well-characterised safety profile. 
• In the European Union (EU), this vaccine has received regulatory approval for active immunisation to prevent IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in children from 2 years of age, adolescents and adults.

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