REG - GSK PLC - US FDA approves Arexvy for adults 18-49 AIR

GSKAnnouncement

13/03/2026 10:45

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RNS Number : 6023W  GSK PLC  13 March 2026

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

 

·   In the US, an estimated 21 million adults under 50 have at least one
risk factor for severe RSV infection 1  (#_edn1) *

 

 

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  (#_edn2) (†) 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
(https://clinicaltrials.gov/study/NCT06389487) )  demonstrating a
non-inferior immune response compared to adults aged 60 years and above. 3 
(#_edn3) Vaccine efficacy was demonstrated in the earlier Phase III trial
(NCT04886596 (https://clinicaltrials.gov/study/NCT04886596) ). 4  (#_edn4) 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 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 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
(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 
(#_edn5) Adults can be at increased risk for RSV disease due to certain
comorbidities, immune compromised status, or advanced age. 6  (#_edn6) 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  (#_edn7) (, 8  (#_edn8) , 9 
(#_edn9) , 10  (#_edn10) )

 

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.

 

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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  (#_ednref1) 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
(https://assets.gskstatic.com/corporate/Congress/2024/IDWeek/DV-009542.pdf) ]

 2  (#_ednref2) 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  (#_ednref3) 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: March 2026.

 4  (#_ednref4) 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: March 2026.

 5  (#_ednref5) 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: March 2026.

 6  (#_ednref6) 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  (#_ednref7) Alfano F, et al. Respiratory Syncytial Virus Infection in
Older Adults: An Update. Drugs Aging. 2014;41:487-505.

 8  (#_ednref8) 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  (#_ednref9) 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  (#_ednref10) 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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