a9780m
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 July 2026
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: 20 July 2026, London UK
European Medicines Agency accepts submission to update Bexsero
label for 1-dose Meningitis B booster in 10+ year olds
●
If approved, a single booster dose could help
protect individuals who were previously vaccinated
with Bexsero
GSK plc (LSE/NYSE: GSK) today announced the European Medicines
Agency (EMA) has accepted a submission to update the label
for Bexsero to include a single dose booster for
individuals aged 10 years and older who were previously vaccinated
with Bexsero.
If a one-dose booster is approved, those vaccinated
with Bexsero in
childhood could receive a single Bexsero dose
at age 10 years or older. If adopted, a booster could
help reduce
the overall burden of Invasive
Meningococcal Disease (IMD) in countries with established infant
MenB programmes.
IMD is an uncommon but severe illness caused
by Neisseria
meningitidis. While the highest
incidence is in infants and young children, there is also a peak in
15-24 year olds1,2,
often linked to behaviours that increase transmission, such as
close contact through kissing, sharing drinks, and living in shared
accommodation3.
The submission is supported by a Phase 3b, open-label, multi-centre
study that evaluated the immune response of
a Bexsero booster dose in individuals 10 to 20 years
old who received the complete primary series during infancy. The
data show a single dose was effective in boosting the immune
responses of individuals vaccinated as infants. Full data will be
presented at the 25th International Pathogenic Neisseria Conference
(IPNC) in September.
About invasive meningococcal disease (IMD)
Invasive meningococcal disease (IMD) is a rare, life-threatening
disease caused by Neisseria
meningitidis that can
progress rapidly and has a fatality rate of
4-20%4.
Up to 20% of IMD survivors have severe, life-changing sequelae, and
the physical and psychological consequences of IMD can
substantially impact quality of life5.
In 2024 in the European Union/European Economic Area, 56% of
confirmed cases of IMD were due to serogroup B in all age groups
under 65 years. The notification rate for IMD was highest among
young children less than 1 year old (6.3 cases per 100 000),
followed by children aged 1-4 years (1.38 confirmed cases per 100
000) and third highest in adolescents and young adults aged 15-24
years (0.83 per 100 000)1.
About Bexsero (4CMenB)
Bexsero is
registered in 61 countries for the prevention of Invasive
Meningococcal Disease (IMD) caused by Neisseria
meningitidis serogroup B.
In Europe, it is included in 15 national and/or regional
immunisation programmes for infants, and 3 national immunisation
programmes for adolescents. Around 138 million doses of Bexsero
have been distributed globally since 20156.
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 www.gsk.com.
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GSK enquiries
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Media:
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Simon Moore
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Investor Relations:
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Constantin Fest
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+44 (0) 7831 826525
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Steph Mountifield
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+44 (0) 7796 707505
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(London)
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Sam Piper
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+44 (0) 7824 525779
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Frannie DeFranco
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+1 215 751 3126
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(Philadelphia)
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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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2025, and
GSK's Q1 Results for 2026.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1. European
Centre for Disease Prevention and Control (ECDC). Invasive
meningococcal disease: Annual Epidemiological Report for 2024
Available at: https://www.ecdc.europa.eu/sites/default/files/documents/invasive-meningococcal-disease-annual-epidemiological-report-2024.pdf.
Last accessed: June 2026
2. UKHSA
2013, Meningococcal: the green book, chapter 22. Available at:
<https://assets.publishing.service.gov.uk/media/6849adb83a2aa5ba84d1df71/Meningococcal-green_book_chapter-22-10-6-25.pdf> Last
accessed: June 2026
3. Burman
C, Serra L, Nuttens C, et al. Meningococcal
disease in adolescents and young adults: a review of the rationale
for prevention through vaccination. Human Vaccines &
Immunotherapeutics. 2019 ;15(2):459-469. <https://doi.org/10.1080/21645515.2018.1528831>
4.
Wang B et al. Vaccine 2019;37:2768-2782.
5. Centers
for Disease Control and Prevention.
https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-14-meningococcal-disease.html.
Last accessed June 2026.
6. GSK
Data on file, REF-310855. 138 million doses shipped from 2015 to
October 2025.
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: July
20, 2026
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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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