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
Arexvy recommended
for adults aged 50-59 at increased risk for severe respiratory
syncytial virus (RSV) disease by US Advisory Committee on
Immunization Practices
●
Over 13 million
adults aged 50-59 at increased risk in the US can potentially
benefit from RSV immunisation1
● RSV causes an estimated 42,000 hospitalisations*
each year in adults aged 50-64 years old in the
US2
GSK plc (LSE/NYSE: GSK) is pleased that the Advisory Committee on
Immunization Practices (ACIP) voted in favour of recommending the
use of RSV vaccines including GSK's Arexvy (Respiratory
Syncytial Virus Vaccine, Adjuvanted) in
adults aged 50-59 who are at increased risk for severe RSV disease.
This includes people with conditions like COPD, asthma, diabetes,
heart disease and those in residential care3.
This expands on ACIP's previous vote in June 2024 to recommend RSV
vaccines for adults aged 60-74 who are at increased risk and all
adults aged 75 and older.
A systematic review of studies in the US shows that RSV is
estimated to cause 42,000 hospitalisations* each
year in adults aged 50-64 years old.2 Adults
with underlying medical conditions, such as chronic obstructive
pulmonary disease (COPD), asthma, heart failure and diabetes are at
increased risk from severe consequences from an RSV infection
compared to those without these conditions.4,5 RSV
can exacerbate these conditions and lead to pneumonia,
hospitalisation, or death.5
Tony Wood, Chief Scientific Officer, GSK: "We are pleased with ACIP's recommendation to
expand the benefits of RSV immunisation to more than 13 million
adults aged 50-59 who are at increased risk for the severe
consequences of this virus. RSV can have a significant impact for
those with underlying medical conditions. We look forward to
helping protect more people with RSV
vaccination".
In making its recommendation, the ACIP considered positive
results from
a phase III trial [NCT05590403]6 evaluating
the immune response and safety of GSK's RSV vaccine in adults aged
50-59, including those at increased risk for RSV-LRTD due to
certain underlying medical conditions compared
to older adults aged 60 years and above where efficacy has been
demonstrated after a single dose of GSK's RSV
vaccine.
The ACIP recommendations will be forwarded for review and approval.
Once approved, the final recommendations will be published to
advise healthcare providers on appropriate use of the vaccine and
to inform insurance coverage.
About GSK's RSV Vaccine
Respiratory Syncytial Virus Vaccine, Adjuvanted, contains
recombinant RSV glycoprotein F stabilised in the prefusion
conformation (RSVPreF3). This antigen is combined with GSK's
proprietary AS01E adjuvant.
The vaccine has been approved for the prevention of RSV-LRTD in
individuals 60 years of age and older in 61 countries, including
Europe, Japan and US. In addition, it is approved in the US, EU/EEA
countries and Japan for use in individuals aged 50-59 who are at
increased risk for lower respiratory disease caused by RSV due to
certain underlying medical conditions. Regulatory reviews for this
extended indication are ongoing in other countries.
The use of this vaccine should be in accordance with official
recommendations. As with any vaccine, a protective immune response
may not be elicited in all vaccinees.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21
adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of
Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary
of Agenus.
About RSV in adults
RSV is a common contagious virus affecting the lungs and breathing
passages. Adults can be at increased risk for RSV disease due to
comorbidities, immune compromised status, or advanced
age.5 RSV
can exacerbate conditions, including COPD, asthma, and chronic
heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.5
Each
year, RSV is estimated to cause approximately 177,000
hospitalisations in adults 65 years and older7 and 42,000*
in adults aged 50-64 years old in the US.2
*adjusted
for under-detection
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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Constantin
Fest
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+44 (0)
7831 826525
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(London)
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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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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
* adjusted
for under-detection
1 Horn
et al, "Disparities in Risk Factors for Severe Respiratory
Syncytial Virus Disease among Adults in the United States",
Abstract presented at National Foundation for Infectious Diseases -
27th Annual
Conference on Vaccinology Research - NFID 2024; May 8-10,
2024
2 McLaughlin
JM et al, "Rates of Medically Attended RSV Among US Adults: A
Systematic Review and Meta-analysis" in Open Forum
Infectious Diseases, Volume 9, Issue 7, July
2022
3 Centers
for Disease Control and Prevention (CDC), RSV vaccine guidance for
older adults, August 2024. Available at: https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html (Accessed
April 2025)
4 Branche
AR et
al.,
« Incidence of Respiratory Syncytial Virus Infection
Among Hospitalized Adults, 2017-2020" in Clinical
Infectious Diseases, 2022:74:1004-1011
5 Centers
for Disease Control and Prevention (CDC), RSV in Adults. Available
at: https://www.cdc.gov/rsv/older-adults/index.html -
accessed in April 2025
6 M.
Ferguson, "Noninferior Immunogenicity and Consistent Safety of
Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults
50-59 Years Compared to ≥60 Years of Age"
in Clinical
Infectious Diseases, 2024 Oct 15;79(4):1074-1084.
doi: 10.1093/cid/ciae364.
7 Falsey,
AR et
al.
"Respiratory syncytial virus infection in elderly and high-risk
adults", in New Engl J
Med 2005;
352:1749-59
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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