GSK plc (LSE/NYSE: GSK) announced that the European Commission (EC) has approved 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 serogroups A, C, W and Y.

This single-vial presentation is now 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.

Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said: “As a leader in meningococcal vaccines, GSK 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 European Union.”

GSK’s submission to the EC was based on two positive Phase IIb trials (2017-003692-61; 2017-003456-23).^1,2 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 lyophilised/liquid formulation.

IMD is an unpredictable but serious illness that can cause life-threatening complications.³ Despite treatment, among those who contract IMD up to one in six will die, sometimes in as little as 24 hours.^4,5 One in five survivors may suffer long-term consequences such as neurological damage⁶, amputations, hearing loss and nervous system problems.⁴ 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.⁷

The original presentation of Menveo that requires reconstitution, and which was approved by the EMA in 2010, is unaffected by this marketing authorisation.⁸