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 April 2025
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:
16 April 2025, London UK
GSK's 5-in-1
meningococcal vaccine Penmenvy receives
positive recommendation from US Advisory Committee on Immunization
Practices
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Vaccine recommended to help protect persons over
10 years old in the United States (US) against disease-causing
serogroups of Neisseria
meningitidis (A, B, C, W
and Y)
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Broad serogroup coverage in one
vaccine reduces injections to help improve vaccination rates and help
protect more US adolescents and young adults
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Vaccine doses will be ready for
use in the US from Summer 2025
GSK plc (LSE/NYSE: GSK) today announced that the
US Centers for Disease Control and Prevention's (CDC) Advisory
Committee on Immunization Practices (ACIP) has voted to recommend
use of Penmenvy (Meningococcal Groups A, B, C, W, and Y
Vaccine) as part of the adolescent meningococcal vaccination
schedule. Recommendations made by the ACIP are reviewed and, if
adopted, are published as official CDC
recommendations.
ACIP voted to recommend that persons over 10 years
old receive a single dose of Penmenvy as an alternative to separate administration
of meningococcal serogroups A, C, W and Y (MenACWY) and
meningococcal serogroup B (MenB) vaccinations when both vaccines
would be given on the same clinic visit, typically at age 16. This
recommendation, if adopted, will allow for vaccination against
serogroups A, B, C, W and Y in fewer doses, could simplify
meningococcal vaccination delivery and could improve immunisation
rates, helping protect more US adolescents against these five
disease-causing serogroups for which the US CDC has previously
issued recommendations.1
GSK's MenABCWY vaccine combines the antigenic
components of the Company's two
well-established meningococcal vaccines-Bexsero (Meningococcal
Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135]
Oligosaccharide Diphtheria CRM197 Conjugate
Vaccine). On 14 February 2025, the US Food and Drug Administration
(FDA) approved GSK's
MenABCWY vaccine for use in individuals aged 10 through 25
years.2
Tony Wood, Chief Scientific
Officer at GSK, said: "We
welcome this positive recommendation that can help strengthen
disease prevention efforts in the US. Pentavalent vaccines can
reduce the number of injections required to help protect against
invasive meningococcal disease - especially disease caused by
serogroup B. Their use could improve immunisation rates among
adolescents and young adults in the US, who are at an age with
increased risk."
Although MenB is the leading cause of invasive
meningococcal disease (IMD) among this population, less than 13% of
17-year-olds received the recommended two-dose vaccination series;
around 32% received at least one dose according to 2023 CDC survey
data.3,4 Three
of every four MenB doses currently administered in the US are
manufactured by GSK,5 positioning
the company well to lead in the US market as MenB-containing
vaccination schedules must be completed with the same
manufacturer's MenB vaccine.6
About IMD
IMD is an uncommon but serious illness that can
lead to death for up to one in six of those who contract it in as
little as 24 hours from onset, despite
treatment.7,8 IMD
is easily misdiagnosed, with early symptoms often mistaken for the
flu.8,9 Approximately
one in five survivors may experience long-term consequences such as
brain damage, amputations, hearing loss, and nervous system
problems.7,9 Although
anyone can get IMD, adolescents and young adults between the ages
of 16 and 23 years are one of the groups at highest risk due to
common behaviours that help transmit the bacteria that cause IMD,
such as living in close quarters like college dormitories, kissing
and sharing drinks, utensils, or smoking
devices.10,11
About Penmenvy
GSK's MenABCWY vaccine is an injectable suspension
for intramuscular use. The vaccine is supplied as one vial of
lyophilized MenACWY Component (powder) which is reconstituted at
the time of use with the accompanying prefilled syringe of MenB
Component (liquid). It is indicated in the US for active
immunization to prevent invasive disease caused
by Neisseria
meningitidis serogroups A,
B, C, W, and Y in individuals aged 10 through 25 years. The US
Prescribing Information is available here.12
About Bexsero
GSK's MenB vaccine has received regulatory
approval in over 55 countries, including the US, and is used in 18
national immunisation programmes worldwide for the prevention of
IMD caused by Neisseria
meningitidis serogroup B.
More than 110 million doses have been distributed worldwide since
2015.13 It
is supported by clinical data supporting its effectiveness in
helping to protect adolescents and young adults against diverse
disease-causing strains of MenB, with a well-characterised safety
profile. In the US, this vaccine has received regulatory approval
for active immunisation to prevent invasive disease caused
by Neisseria
meningitidis serogroup B
in individuals aged 10 through 25 years. The US Prescribing
Information is available here.14
About Menveo
GSK's MenACWY vaccine has
received regulatory approval in over 60 countries, including the
US, with more than 80 million doses distributed worldwide since
2010.15 It
offers evidence of immunogenicity with a well-characterised safety
profile. In the US, this vaccine has received regulatory approval
for active immunisation to prevent IMD caused
by Neisseria
meningitidis serogroups A, C, Y, and W
in individuals from 2 months through 55 years of age. The US
Prescribing Information is available here.16
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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GSK enquiries
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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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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Alison Hunt
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+1 540 742 3391
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(Washington DC)
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Investor Relations:
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Annabel Brownrigg-Gleeson
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+44 (0) 7901 101944
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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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Constantin Fest
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+44 (0) 7831 826525
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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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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 4855
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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
2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References:
1.
Centers for Disease
Control and Prevention. About
Meningococcal Vaccines. Available
at: https://www.cdc.gov/vaccines/vpd/mening/hcp/about-vaccine.html.
Accessed April 2025.
2. GSK. Penmenvy,
GSK's 5-in-1 meningococcal vaccine, approved by US FDA to help
protect against MenABCWY. Available at: https://www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/. Accessed
April 2025.
3.
Cheng
WY, et
al. Determinants
of Meningococcal ACWY vaccination in adolescents in the US:
completion and compliance with the CDC
recommendations. Hum Vaccin
Immunother.
2020;16(1):176-188.
4.
Centers for Disease
Control and Prevention. National
Vaccination Coverage Among Adolescents Aged 13-17 Years - National
Immunization Survey-Teen, United States, 2023. Available
at: https://www.cdc.gov/mmwr/volumes/73/wr/
mm7333a1.htm#:~:text=Among%20adolescents%20aged%2013%E2%80%9317%20years%20included%20in%20the%202023,view%2Fcdc%2F159388.
Accessed April 2025.
5. GSK Data on
File Calculation of GSK share in US
MenB market January - December 2024. REF-269547. Based on information licensed from
IQVIA: IQVIA, DDD, Meningococcal B market all channels, period
January - December 2024, reflecting estimates of real-world
activity. All rights reserved.
6.
Centers for Disease
Control and Prevention. Meningococcal
Vaccine Recommendations. Available
at: https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html.
Accessed April 2025.
7.
World Health
Organisation. Meningitis fact sheet. Available
at: https://www.who.int/news-room/fact-sheets/detail/meningitis.
Accessed April 2025.
8.
Thompson MJ, et al.
Clinical recognition of meningococcal disease in children and
adolescents. Lancet. 2006;367(9508):397-403.
9.
Marshall GS, et al.
Understanding the Sequelae of Invasive Meningococcal Disease in the
United States. Infect Dis Ther.
2024;13(11):2213-2220.
10. European Centers for Disease
Control and Prevention. Outbreak of
invasive meningococcal disease in the EU associated with a mass
gathering event, the 23rd World Scout Jamboree, in
Japan. 21
August 2015. Available at: https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/Meningococcal-disease-scouts-EU-August-2015.pdf.
Accessed April 2025.
11. Centers for Disease Control and
Prevention. Risk Factors for Meningococcal Disease. Available
at: https://www.cdc.gov/meningococcal/risk-factors/index.html.
Accessed April 2025.
12. GSK. US Prescribing Information
for Penmenvy.
Available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF.
Accessed April 2025.
13. GSK Data on File. Number
of Bexsero doses
shipped from 2015 to November 2023 REF-219766
14. GSK. US Prescribing Information
for Bexsero.
Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF. Accessed
April 2025.
15. GSK Data on
File. Menveo Doses
Shipped from 2010 to end of 2022 REF-195452
16. GSK. Prescribing Information
for Menveo.
Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF. Accessed
April 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: April
17, 2025
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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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