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 May 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: 18 May 2026, London UK
GSK's RSV vaccine, Arexvy, receives expanded approval in
Japan for adults aged 18-59 at increased risk
●
First
RSV vaccine approved for adults aged 18-59 years at increased risk
and for all adults 60 years and older in Japan
●
In
Japan, millions of adults live with certain chronic conditions that
increase their risk of severe RSV outcomes[1],[2],[3],[4],[5],[6]
GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of
Health, Labour and Welfare (MHLW) has expanded the eligible
population for Arexvy (Respiratory
Syncytial Virus vaccine, [adjuvanted, recombinant]), to
include adults
aged 18 to 49 years at increased risk (AIR) for RSV disease. GSK's
RSV vaccine was previously approved in Japan for the prevention of
RSV disease in all adults aged 60 years and older, and for adults
aged 50-59 AIR for RSV disease. The
prescribing information for Arexvy has also been updated to explicitly include
immuno-compromised (IC) patients as an increased risk group -
helping clinicians to identify people who may benefit from RSV
prevention.
Sanjay Gurunathan, GSK
Head of Vaccines and Infectious Diseases Research and
Development, said:
"This expanded approval, the first covering all at-risk adults in
Japan, can help reduce potentially severe outcomes of RSV. It
recognises the serious impact RSV can have for adults of any age
living with chronic conditions such as cardiovascular disease,
chronic obstructive pulmonary disease and asthma, and it enables
more people to take a proactive approach to disease
prevention."
RSV is a common and contagious respiratory virus that can cause
serious illness in adults, particularly those living with certain
chronic conditions.6,[7],[8] RSV
infection can cause major adverse cardiovascular events (MACE)
including heart attack and stroke,4,[9],[10],[11],[12] trigger
flare-ups of chronic obstructive pulmonary disease (COPD) and
asthma and may result in severe illness, hospitalisation, and even
death.6 More
than 42 million adults in Japan are aged
18-491 and,
while often considered at low risk of RSV, many in this group live
with underlying chronic conditions.2
The approval was supported
by data from a Phase IIIb trial (NCT06389487)
demonstrating a non-inferior immune response in adults aged 18 to
49 years AIR for RSV disease compared
to adults aged 60 years and above.[13] Vaccine
efficacy was demonstrated in the earlier Phase III trial
(NCT04886596).[14] The
safety profile was consistent with findings from the broader Phase
III programme that supported the initial
approval with
the most common adverse events being injection site pain, myalgia,
fatigue, arthralgia and headache, which were largely transient and
mild to moderate in intensity.13 The
update to the prescribing information to include IC
patients, accepted
by Japan's
Pharmaceuticals and Medical Devices Agency (PMDA), was
supported by data from a Phase IIb trial (NCT05921903).[15]
GSK continues to advance regulatory
submissions for its RSV vaccine across multiple geographies to
expand availability and
support disease prevention.
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 years who are at
increased risk due to certain underlying medical conditions in more
than 60 countries. In the US it is also approved in adults aged
18-49 years at increased risk, and in the European Economic Area
for all adults aged 18 years and older.[16],[17]
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 updated Product Information (PI) for
precautions concerning indications, dosage and administration and
safety information in Japan at this link: Japan
Pharmaceuticals and Medical Devices Agency[18]
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=1,029), compared to participants aged 60 years and
above (n=429) after a single dose of GSK's RSV
vaccine.13 Of
the 18-49 cohort, 426 were included in the immunogenicity analysis
and 603 were assessed for safety only.13 A
total of 1,458 participants were enrolled across 52 locations in
six countries, including four sites in Japan.13
The trial's primary endpoints were RSV-A and RSV-B neutralisation
titres expressed as mean geometric titre ratio (relative to older
adults over adults at increased risk) and sero-response rate in
RSV-A and RSV-B neutralising titres one month post vaccine
administration.13 There
were also safety and immunogenicity secondary and tertiary
endpoints.13
About the NCT04886596 trial
NCT04886596 is a Phase III, randomised,
placebo-controlled, observer-blind, multi-country trial to evaluate
vaccine efficacy of a single dose, and annual revaccination doses
of GSK's RSV vaccine, in preventing RSV-LRTD in
adults aged 60 years and above.14 A
total of 26,675 participants were enrolled across 277 locations in
17 countries, including 14 sites in Japan.14 The
trial's primary endpoint was vaccine efficacy against
RSV-LRTD after
one RSV season following a single dose of
the vaccine.14 There
were also efficacy, safety and immunogenicity secondary and
tertiary endpoints.14
About the NCT05921903 trial
NCT05921903 is a Phase IIb, open-label,
multi-country, descriptive immunogenicity and safety
trial in IC participants
who were recipients of lung or kidney transplant, and aged 18 years
and above at increased risk for severe lower respiratory tract
disease (LRTD) caused by RSV (n=261).15 The
trial compared one (n=131) versus two (n=130) doses of GSK's RSV
vaccine in IC and AIR participants, and also compared to a control
group of non-immunocompromised adults aged 50 and above receiving a
single dose (n=125).15 A
total of 386 participants were enrolled across 46 locations in
eight countries, including eight sites in Japan.15 The
trial's co-primary endpoints were RSV-A and RSV-B
neutralisation titres following a first and a second dose of GSK's
RSV vaccine, measured at approximatively one month (30-42 days)
after the respective vaccination, expressed as mean geometric
increase post dose two relative to post dose
one.15 There
were also safety and immunogenicity secondary and tertiary
endpoints.15
The results demonstrated that a single dose of the vaccine showed a
robust immune response in the study population.15 The
safety profile was consistent with findings from the broader Phase
III programme that supported the initial approval, with the most
common adverse events being injection site pain, myalgia,
fatigue, arthralgia
and headache.15
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.7 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 The
true number of RSV-related cases is likely underestimated due to
lack of routine testing.[19],[20]
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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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] E-Stat:
Statistics of Japan. Available at: https://www.e-stat.go.jp/en/stat-search/files?page=1&layout=datalist&toukei=00200524&tstat=000000090001&cycle=1&tclass1=000001011678&tclass2val=0.
Last accessed: May 2026.
[2] Saito
Y, et
al. Prevalence of
multimorbidity and its associations with hospitalisation or death
in Japan 2014-2019: a retrospective cohort study using nationwide
medical claims data in the middle-aged
generation. BMJ
Open.
2023;13(5):e063216.
[3] Njue
A, et
al. Systematic Literature
Review of Risk Factors for Poor Outcomes Among Adults With
Respiratory Syncytial Virus Infection in High-Income Countries.
Open Forum Infectious Diseases (2023) 10(11):
ofad513.
[4] Montiel
J, et
al. The
risk of cardiac disease events after respiratory syncytial virus
disease: a systematic literature review and meta-analysis. European
Respiratory Review (2026); 35:250160.
[5] Penders
Y, et al. Burden
of Respiratory Syncytial Virus Disease in Adults with Asthma and
Chronic Obstructive Pulmonary Disease: A Systematic Literature
Review. Current Allergy and Asthma Reports.
2025;25:14.
[6] Falsey
AR, et
al. Respiratory syncytial virus
infection in elderly and high-risk adults. New Engl J
Med.
2005;352:1749-1759.
[7] 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: May 2026.
[8] Branche
AR; et
al. Incidence of Respiratory
Syncytial Virus Infection Among Hospitalized Adults, 2017-2020.
Clin Infect
Dis.2022;74;1004-1011.
[9] Hviid
A, et
al. Cardiovascular Events 1
Year After Respiratory Syncytial Virus Infection in Adults. JAMA
Netw Open. 2025;8(12):e2547618.
[10] Liang
C, et
al. Risk
of Cardiorespiratory Events Following Respiratory Syncytial
Virus-Related Hospitalization. JAMA Netw Open.
2026;9(2):e2556767
[11] Sudnik
P, et
al. Comprehensive Analysis of
Cardiovascular Events and Risk Factors in Patients Hospitalized
With Respiratory Syncytial Virus. Clin Infect Dis. 2026 Feb
25;82(2):e396-e403.
[12] Woodruff
R, et
al. Acute
Cardiac Events in Hospitalized Older Adults With Respiratory
Syncytial Virus Infection. JAMA Intern Med.
2024;184(6):602-611.
[13] 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: May 2026.
[14] 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: May 2026.
[15] Clinicaltrials.gov.
A Study on the Immune Response and Safety of an RSV Vaccine When
Given to Adults 18 Years of Age and Above Who Received Lung or
Kidney Transplant and Are at an Increased Risk of Respiratory
Syncytial Virus Lower Respiratory Tract Disease and Compared to
Healthy Adults 50 Years of Age and Above (RSV OA=ADJ-023).
Available at: https://clinicaltrials.gov/study/NCT05921903.
Last accessed: May 2026.
[16] GSK.
Arexvy. US Prescribing Information. Available
at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF.
Last accessed: May 2026.
[17] EMA.
Arexvy. Summary of Product Characteristics. Available
at: https://www.ema.europa.eu/en/documents/product-information/arexvy-epar-product-information_en.pdf.
Last accessed: May 2026.
[18] Japan
Pharmaceuticals and Medical Devices Agency. Pharmaceuticals
Information. Available at: https://www.pmda.go.jp/PmdaSearch/iyakuSearch/ Last
accessed May 2026
[19] 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.
[20] 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: May
18, 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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