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 March 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: 13 March 2026, London UK
GSK's RSV
vaccine, Arexvy, approved in US for expanded age indication in
adults aged 18-49 years at increased risk
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In the US, an estimated 21
million adults under 50 have at least one risk factor for severe
RSV infection[1]*
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has expanded the approved age indication
of Arexvy (Respiratory
Syncytial Virus vaccine, [adjuvanted]) to adults
aged 18 to 49 years at increased risk for lower respiratory tract
disease (LRTD) caused by RSV. GSK's RSV vaccine was previously
approved in the US for the prevention of RSV-related LRTD in adults
aged 60 and older, and adults aged 50-59 at increased risk for LRTD
caused by RSV. This vaccine is
not for use in pregnant individuals.
Sanjay Gurunathan, GSK
Head of Vaccines and Infectious Diseases Research and
Development, said: "This
age expansion can help address a significant medical need for
adults in the United States at higher risk of severe RSV disease
due to certain underlying conditions, and help ease pressure on the
healthcare system. We are proud of this latest step in our strategy
to bring RSV prevention to broader adult
populations."
The annual RSV burden among US adults aged 18-49 years is about
17,000 hospitalisations, 277,000 emergency department admissions,
and 1.97 million outpatient visits.[2]† Most
hospitalisations in younger adults occur in those with chronic
medical conditions which place them at increased risk for severe
RSV disease (e.g. chronic cardiopulmonary, kidney or renal disease,
obesity and diabetes).2†
The FDA's decision was supported by data from a Phase IIIb
trial (NCT06389487)
demonstrating a non-inferior immune response compared
to adults aged 60 years and above.[3] Vaccine
efficacy was demonstrated in the earlier Phase III trial
(NCT04886596).[4] The
safety profile was consistent with findings from the broader Phase
III programme that supported the initial US approval, with the most
common adverse events being injection site pain, fatigue, myalgia,
headache, and arthralgia within four days of
vaccination.3
GSK continues to advance regulatory
submissions for its RSV vaccine across multiple geographies to
expand availability and
support long-term growth objectives.
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
before administration.
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 vaccine has been approved for the prevention of RSV-LRTD in
individuals 60 years of age and older in 70 countries. In addition,
it is approved for use in individuals aged 50-59 who are at
increased risk due to certain underlying medical conditions in more
than 60 countries. In the European Economic Area it is approved for
adults aged 18 years and older.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21
adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of
Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary
of Agenus.
Please refer to the full US Prescribing Information (PI) for
important dosage, administration, and safety
information: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF
About the NCT06389487 trial
NCT06389487 is a Phase IIIb, open-label multi-country
immunogenicity trial to evaluate the non-inferiority of the immune
response and evaluate safety in participants aged 18-49 at
increased risk for lower respiratory tract disease (LRTD) caused by
RSV (n=426), compared to participants aged 60 years and above
(n=429) after a single dose of GSK's RSV vaccine. An additional
cohort, of 603 participants aged 18-49, was followed up for adverse
events separate to safety follow up of the initial cohort. A total
of 1,458 participants were enrolled across 52 locations in six
countries, including 16 US sites.
The study assessed the immune response in participants aged 18-49
with pre-defined stable chronic diseases leading to an increased
risk for RSV disease, compared to those aged 60 years and above.
The trial's primary endpoints were RSV-A and RSV-B neutralisation
titres of adults aged 18 - 49 years at one month after the vaccine
administration compared to adults aged 60 and older. There were
also safety and immunogenicity secondary and tertiary endpoints.
Safety and reactogenicity data were consistent with results from
the initial data read out in NCT04886596. The most common local
adverse event was pain. The most common systemic adverse events
were myalgia, fatigue and headache, which were largely transient
and mild to moderate in intensity.
About RSV in adults
RSV is
a common contagious virus affecting the lungs and breathing
passages and impacts an estimated 64 million people of all ages
globally every year.[5] Adults
can be at increased risk for RSV disease due to certain
comorbidities, immune compromised status, or advanced
age.[6] RSV
can exacerbate certain conditions,
including COPD, asthma, and chronic heart failure and can lead to
severe outcomes, such as pneumonia, hospitalisation, and
death.6 Compared
to children, adults hospitalised for RSV are at a higher risk of
severe complications, require more costly treatments, have a higher
fatality rate, and the true number of RSV-related cases is likely
underestimated due to lack of routine testing.[7],[8],[9],[10]
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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(Washington
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Lyndsay
Meyer
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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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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.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
Footnotes
*
Self-reported diagnoses of risk factors collected via the National
Health and Nutrition Examination Survey (NHANES) in US adults 20-49
years of age. The figure of 21.3 million is based on 17.0% of a
total 125,255,765 adults 20-49 who had at least one risk factor
(including congestive heart failure, coronary heart disease,
stroke, angina, myocardial infarction, chronic obstructive
pulmonary disease, asthma, diabetes, liver disease and/or renal
disease) for severe RSV disease
†
Based on a systematic review and meta-analysis of studies
describing population-based rates of medically attended RSV among
US adults (n=14 articles published between 2007 and 2021).
Estimates were based on RSV as detected by RT-PCR of NP or nasal
swabs and then adjusted for under detection. Age-specific US census
population estimates were applied to project the expected number of
annual cases.
References:
[1] Horn
et al, "Characteristics Associated with the Presence of One or More
Risk Factors for Severe Respiratory Syncytial Virus Disease among
Adults in the United States", poster presented at ID Week 2024
[available on demand: P691 - DV-009542.pdf]
[2] McLaughlin
JM, et al. Rates of Medically Attended RSV Among US Adults: A
Systematic Review and Meta-analysis. Page 17 Supplementary Data.
Open Forum Infect Dis. 2022 Jun 17;9(7):ofac300. doi:
10.1093/ofid/ofac300. PMID: 35873302; PMCID:
PMC9301578.
[3] Clinicaltrials.gov.
A Study on the Immune Response and Safety of Vaccine Against
Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of
Age at Increased Risk for Respiratory Syncytial Virus Disease,
Compared to Older Adults 60 Years of Age and Above. Available
at: https://clinicaltrials.gov/study/NCT06389487.
Last accessed: March 2026.
[4] Clinicaltrials.gov.
Efficacy Study of GSK's Investigational Respiratory Syncytial Virus
(RSV) Vaccine in Adults Aged 60 Years and Above. Available
at: https://clinicaltrials.gov/study/NCT04886596.
Last accessed: March 2026.
[5] National
Institute of Allergy and Infectious Diseases, Respiratory Syncytial
Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv.
Last accessed: March 2026.
[6] Falsey,
A, R et
al. Respiratory syncytial virus
infection in elderly and high-risk adults,
in New Engl J
Med 2005;
352:1749-59. doi: 10.1056/NEJMoa043951.
[7] Alfano
F, et
al.
Respiratory Syncytial Virus Infection in Older Adults: An
Update. Drugs
Aging. 2014;41:487-505.
[8] Niekler
P, et
al.
Hospitalizations due to respiratory syncytial virus (RSV)
infections in Germany: a nationwide clinical and direct cost data
analysis (2010-2019). Infection.
2024;52(5):1715-1724.
[9] Günen
H, et
al. Key
Challenges to Understanding the Burden of Respiratory Syncytial
Virus in Older Adults in Southeast Asia, the Middle East, and North
Africa: An Expert Perspective. Adv
Ther. 2024;41(11):4312-4334.
[10] Grace
M, et
al. Economic
burden of respiratory syncytial virus infection in adults: a
systematic literature review. J Med
Econ. 2023;26(1):742-759.
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: March
13, 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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