GSK Gsk Plc

Issued: 27 November 2024, London UK

GSK's fully liquid Menveo meningococcal vaccine approved by European Commission

·   New fully liquid presentation means reconstitution is not needed before use

·   Formulation supports simplification of vaccination process against invasive meningococcal disease (IMD)

·   IMD is an unpredictable but serious illness that can cause life-threatening complications

GSK plc (LSE/NYSE: GSK) today 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 damage[6], 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]

About Menveo

GSK's MenACWY vaccine has received regulatory approval in over 60 countries.[9] It offers evidence of immunogenicity with a well-characterised safety profile.[10]^,[11] 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.[12] EMA Prescribing Information for Menveo can be accessed at: https://www.ema.europa.eu/en/medicines/human/EPAR/menveo.¹²  More than 82 million doses of this vaccine have been distributed worldwide since 2010;[13] over 6 million doses have been distributed to European countries since 2017.[14]

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and GSK's Q3 Results for 2024.

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