REG - GSK PLC - GSK liquid meningitis vaccine authorised in EU

GSKAnnouncement

27/11/2024 07:00

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RNS Number : 7340N  GSK PLC  27 November 2024

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
(https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003692-61/results)
; 2017-003456-23
(https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003456-23/results)
). 1  (#_edn1) (, 2  (#_edn2) ) 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  (#_edn3) Despite treatment, among those who contract IMD up
to one in six will die, sometimes in as little as 24 hours. 4  (#_edn4) (, 5 
(#_edn5) ) One in five survivors may suffer long-term consequences such as
neurological damage 6  (#_edn6) , 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  (#_edn7)

 

The original presentation of Menveo that requires reconstitution, and which
was approved by the EMA in 2010, is unaffected by this marketing
authorisation. 8  (#_edn8)

 

About Menveo

GSK's MenACWY vaccine has received regulatory approval in over 60
countries. 9  (#_edn9) It offers evidence of immunogenicity with a
well-characterised safety profile. 10  (#_edn10) (, 11  (#_edn11) ) 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 
(#_edn12) EMA Prescribing Information for Menveo can be accessed at:
https://www.ema.europa.eu/en/medicines/human/EPAR/menveo
(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  (#_edn13) over 6 million doses have been distributed to European
countries since 2017. 14  (#_edn14)

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.

 

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WC1A 1DG

 

 1  (#_ednref1) 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  (#_ednref2) 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  (#_ednref3) 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  (#_ednref4) Thompson MJ;Lancet;2006;367;397-403 Clinical recognition of
meningococcal disease in children and adolescents_REF-2803.

 

 5  (#_ednref5) Pelton, S.I. Meningococcal disease awareness: Clinical and
epidemiological factors affecting prevention and management in adolescents,
Journal of Adolescent Health, 2009; 46(2).

 

 6  (#_ednref6) World Health Organization (WHO), Meningitis Factsheet, 2023.
Available at: https://www.who.int/news-room/fact-sheets/detail/meningitis.
Accessed November 2024.

 

 7  (#_ednref7) 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  (#_ednref8) 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  (#_ednref9) Data on File: List of countries where Menveo is registered
and/or commercialized_ REF-19494.

 

 10  (#_ednref10) 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  (#_ednref11) 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.

 

 12  (#_ednref12) EMA, Menveo: EPAR - Product Information - Summary of Product
Characteristics. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/menveo
(https://www.ema.europa.eu/en/medicines/human/EPAR/menveo) .

Accessed November 2024.

 

 13  (#_ednref13) Data on File: Menveo Doses Shipped from 2010 to end of
2022_REF-195452.

 

 14  (#_ednref14) Data on file: Menveo doses distributed in Europe from 2017
to August 31st 2024_REF-246217.

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