UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of November 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
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.
[12] EMA, Menveo: EPAR - Product Information - Summary
of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/menveo.
Accessed November
2024.
[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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: November
27, 2024
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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