REG - GSK PLC - Japan MHLW approves Arexvy for adults 18-49 AIR

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RNS Number : 5824E  GSK PLC  18 May 2026

 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  (#_edn1) )(, 2  (#_edn2) , 3 
(#_edn3) , 4  (#_edn4) , 5  (#_edn5) ,)( 6  (#_edn6) )

 

 

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  (#_edn7) (, 8  (#_edn8) ) RSV infection can cause major
adverse cardiovascular events (MACE) including heart attack and stroke,(4, 9 
(#_edn9) , 10  (#_edn10) , 11  (#_edn11) , 12  (#_edn12) ) 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 18-49(1) 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
(https://clinicaltrials.gov/study/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  (#_edn13) Vaccine efficacy was
demonstrated in the earlier Phase III trial (NCT04886596
(https://clinicaltrials.gov/study/NCT04886596) ). 14  (#_edn14) 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
(https://clinicaltrials.gov/study/NCT05921903?term=NCT05921903&viewType=Card&rank=1)
). 15  (#_edn15)

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 AS01(E) 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  (#_edn16) (, 17 
(#_edn17) )

 

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
(https://www.pmda.go.jp/PmdaSearch/iyakuSearch/)  18  (#_edn18)

 

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  (#_edn19) (, 20  (#_edn20) )

 

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
(https://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.

 

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References:

 1  (#_ednref1) 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
(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  (#_ednref2) 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  (#_ednref3) 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  (#_ednref4) 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  (#_ednref5) 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  (#_ednref6) Falsey AR, et al. Respiratory syncytial virus infection in
elderly and high-risk adults. New Engl J Med. 2005;352:1749-1759.

 7  (#_ednref7) National Institute of Allergy and Infectious Diseases,
Respiratory Syncytial Virus (RSV). Available at:
https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
(https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv)
. Last accessed: May 2026.

 8  (#_ednref8) Branche AR; et al. Incidence of Respiratory Syncytial Virus
Infection Among Hospitalized Adults, 2017-2020. Clin Infect
Dis.2022;74;1004-1011.

 9  (#_ednref9) Hviid A, et al. Cardiovascular Events 1 Year After Respiratory
Syncytial Virus Infection in Adults. JAMA Netw Open. 2025;8(12):e2547618.

 10  (#_ednref10) Liang C, et al. Risk of Cardiorespiratory Events Following
Respiratory Syncytial Virus-Related Hospitalization. JAMA Netw Open.
2026;9(2):e2556767

 11  (#_ednref11) 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  (#_ednref12) 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  (#_ednref13) 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
(https://clinicaltrials.gov/study/NCT06389487) . Last accessed: May 2026.

 14  (#_ednref14) 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
(https://clinicaltrials.gov/study/NCT04886596) . Last accessed: May 2026.

 15  (#_ednref15) 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
(https://clinicaltrials.gov/study/NCT05921903) . Last accessed: May 2026.

 16  (#_ednref16) GSK. Arexvy. US Prescribing Information. Available at:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF)
. Last accessed: May 2026.

 17  (#_ednref17) EMA. Arexvy. Summary of Product Characteristics. Available
at:
https://www.ema.europa.eu/en/documents/product-information/arexvy-epar-product-information_en.pdf
(https://www.ema.europa.eu/en/documents/product-information/arexvy-epar-product-information_en.pdf)
. Last accessed: May 2026.

 18  (#_ednref18) Japan Pharmaceuticals and Medical Devices Agency.
Pharmaceuticals Information. Available at:
https://www.pmda.go.jp/PmdaSearch/iyakuSearch/
(https://www.pmda.go.jp/PmdaSearch/iyakuSearch/) Last accessed May 2026

 19  (#_ednref19) 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  (#_ednref20) 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.

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