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.
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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.
Registered in England & Wales:
No. 3888792
Registered Office:
79 New Oxford Street
London
WC1A 1DG
[1] EU Clinical Trials
Register, A phase 2b, randomized, controlled, observer-blind,
multi-center, non-inferiority immunogenicity and safety study of
two formulations of GSK Biologicals' Meningococcal ACWY conjugate
vaccine (GSK3536820A and Menveo) administered to healthy adults 18
to 40 years of age. Available at:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003692-61/results.
Accessed September 2024.
[2] EU Clinical Trials
Register, A phase 2b, randomized, controlled, observer-blind,
multi-center study to evaluate safety and immunogenicity of
different formulations of GSK Biologicals' Meningococcal ACWY
conjugate vaccine (GSK3536820A and Menveo) administered to healthy
adolescents and young adults 10 to 40 years of age. Available at:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003456-23/results.
Accessed September 2024.
[3] European Centre
for Disease Prevention and Control (ECDC), Factsheet about
Meningococcal Disease, 2023. Available at:
https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet.
Accessed November 2024.
[4] Thompson
MJ;Lancet;2006;367;397-403 Clinical recognition of meningococcal
disease in children and adolescents_REF-2803.
[5] Pelton, S.I.
Meningococcal disease awareness:
Clinical and epidemiological factors affecting prevention and
management in adolescents, Journal of Adolescent Health,
2009; 46(2).
[6] World Health
Organization (WHO), Meningitis Factsheet, 2023. Available at:
https://www.who.int/news-room/fact-sheets/detail/meningitis.
Accessed November 2024.
[7] Invasive
meningococcal disease - Annual Epidemiological Report for 2022:
Available at:
https://www.ecdc.europa.eu/en/publications-data/invasive-meningococcal-disease-annual-epidemiological-report-2022.
Accessed November 2024.
[8] EC Decision
C(2010)1795 of 16 March 2010 and subsequent amendments; marketing
authorisation numbers EU/1/10/614/002 &
EU/1/10/614/003.
[9] Data on File:
List of countries where Menveo is
registered and/or commercialized_ REF-19494.
[10] Becerra-Culqui TA, Sy LS, Ackerson BK, et al. Safety of quadrivalent meningococcal
conjugate vaccine in infants and toddlers 2 to 23-months
old. Vaccine. 2020; 38(2), 228-234.
[11] Khatami A,
Snape MD, Davis E, et al. Persistence of the immune response at 5 years
of age following infant immunisation with investigational
quadrivalent
MenACWY conjugate vaccine formulations.
Vaccine. 2012; 30:2831-2838.
[13] Data on
File: Menveo Doses Shipped from
2010 to end of 2022_REF-195452.
[14] Data on
file: Menveo doses distributed in
Europe from 2017 to August 31st 2024_REF-246217.
