AREXVY becomes the first Respiratory Syncytial Virus (RSV) vaccine added to the National Immunisation Program for older Australians
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More than 2 million Australians aged 75+, and Aboriginal and Torres Strait Islander people aged 60+, are now eligible for GSK’s recombinant respiratory syncytial virus (RSV) adjuvanted vaccine, AREXVY, through their GP or pharmacist.
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The vaccine helps protects against lower airway infection caused by the contagious respiratory syncytial virus.1
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AREXVY becomes the first RSV vaccine for older adults to be included on the Federal Government’s National Immunisation Program (NIP) from 15 May 2026.
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Whilst usually mild, RSV can cause serious health complications in older adults, which can include pneumonia, respiratory failure and, in rare cases, even death.2,3
GSK Australia welcomes the Australian Government’s decision to include AREXVY [Recombinant Respiratory Syncytial Virus pre-fusion F protein (RSVPreF3) (AS01E adjuvanted vaccine)]1 on the National Immunisation Program (NIP), for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in older adults.
From 15 May 2026, more than 2 million Australians aged 75 and over, and Aboriginal and Torres Strait Islander people aged 60 years and over, will be able to receive the funded AREXVY vaccine, as part of a national effort to reduce serious illness caused by RSV.
“Including an RSV vaccine for older adults on the National Immunisation Program is a clear signal that immunisation is a lifelong strategy, which doesn’t stop at childhood,” said Catherine Hughes, Co-Founder and Executive Director of Immunisation Foundation Australia. “It will help to protect older adults from serious respiratory illness whilst preventing avoidable hospital admissions and easing pressures on the health system during peak respiratory seasons.”
RSV is a common, contagious respiratory virus,2,4 which spreads mainly via inhalation of respiratory droplets from infected people and through contact with contaminated surfaces.2 Symptoms are often similar to other acute respiratory infections,5,6 blocked or runny nose, cough, tiredness, sore throat, muscle aches and headache.2,6,7 However, RSV can cause severe illness in older adults5,8, sometimes leading to hospitalisation and in rare cases, death.9,10 A laboratory test is required to confirm an RSV diagnosis.2
“Older Australians are the pillars of our community. Many are actively involved in caring for grandchildren, which can increase their exposure to RSV,” said Chris Grice, Chief Executive Officer of National Seniors Australia (NSA). “RSV is easily spread among family members, so it’s important for older adults to be aware of the risk and impact to their health. This funding recognises the risks and supports older people to make informed decisions about protecting their health.”
An Australian study has shown that while RSV hospitalisation rates are highest in young children, older adults who are hospitalised with RSV experience longer hospital stays and more in-hospital deaths compared with young children,10 partly because immunity tends to weaken with age, making it harder for older adults to fight off infections like RSV.2,11
Older adults discharged after an RSV hospitalisation may face long‑term health complications, increased need for care and loss of independence. 12,13 Aboriginal and Torres Strait Islander peoples are disproportionately represented among RSV hospitalisations.10,14 People with chronic conditions, including COPD, asthma, congestive heart failure and diabetes, have a greater likelihood of severe disease and hospitalisation due to RSV compared with people without these conditions.5,9
“We regularly hear from older Australians whose lives are disrupted after a severe RSV infection, particularly those already managing conditions like COPD or asthma,” said Mark Brooke, Chief Executive Officer of Lung Foundation Australia. “Funded access to an RSV vaccine gives older people at highest risk, an important opportunity to make an informed decision that may prevent serious illness, stay out of hospital, and help maintain their quality of life.”
In Australia, RSV infections can occur all year round but usually peak in autumn and winter in temperate areas, and after the rainy season in tropical regions.14,15,16 In 2025, Australia experienced almost 180,000 cases of RSV nationwide, with more than 40,000 cases in adults over 60, according to the National Notifiable Diseases Surveillance System.17
“RSV has long been under-recognised as a serious health threat in older adults. This announcement is a meaningful acknowledgment of the burden RSV places on older Australians and their families. Enabling older Australians to access a funded RSV vaccine is a proactive step towards prevention. AREXVY can be given at the same time as the flu jab, making appointments more time efficient,” said Professor Charlotte Hespe AM, Head of General Practice and Primary Care Research at the School of Medicine, Sydney.
RSV infection is a nationally notifiable disease and viewed by the Federal Government as a risk to public health, alongside other respiratory diseases like influenza and COVID.18
“Inclusion of AREXVY on the National Immunisation Program demonstrates GSK’s commitment to protect older Australians from RSV. This decision recognises the significant health burden RSV can place on older adults and Aboriginal and Torres Strait Islander people,” said Dr Alan Paul, Executive Country Medical Director, GSK Australia.
AREXVY is now available and funded on the NIP for Australians aged 75 and over and Aboriginal and Torres Strait Islander people aged 60 and over. Outside of these groups, AREXVY is indicated for adults aged over 60 years, and adults 50-59 years who are at increased risk of RSV disease, but is not funded under the NIP for these groups.1 Older adults should consult their healthcare professional for further information on RSV.
AREXVY was registered by the Therapeutic Goods Administration (TGA) in Australia in 2024, based on the results of GSK’s international phase III clinical trial program involving 17 countries, including Australia, which compared AREXVY with placebo in almost 25,000 older adults.1
Patients should consult with their healthcare professional for further information on RSV.
Media contact:
• Cube: Natasha Silkin | tash@cube.com.au | 0494 408 965
• GSK: Helena Sfelagis | helena.x.sfelagis@gsk.com | 0478 261 568
About AREXVY (Recombinant Respiratory Syncytial Virus pre-fusion F protein (RSVPreF3) (AS01E adjuvanted vaccine)
- ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. You can help by reporting any side effects you may get to your doctor, or directly at www.tga.gov.au/reporting-problems.
- Indication: For active immunisation for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older; and adults 50 through 59 years of age who are at increased risk for RSV disease.
- PBS Information: AREXVY is available on the National Immunisation Program (NIP) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in people aged 75 and older, or Aboriginal and Torres Strait Islander people aged 60 and older.
- Safety: Very common adverse events (≥10%) are headache, muscle pain, joint pain, injection site pain and fatigue. Common adverse events (≥1%) are injection site redness, injection site swelling, fever, chills and runny nose (not a complete list; see full CMI).
- Precautions: For intramuscular use only. Should be given with caution to individuals with thrombocytopenia or any coagulation disorder where bleeding may occur. Safety and immunogenicity data on AREXVY are not available for immunocompromised individuals. Guillain-Barré Syndrome has been reported very rarely following vaccination with AREXVY in individuals ≥ 60 years. The safety and efficacy of AREXVY have not been established in children and adolescents.
- Contraindications: Hypersensitivity to the active substances or to any component of the vaccine.
- Interactions: AREXVY can be given concomitantly with inactivated seasonal influenza vaccines (standard dose unadjuvanted, high dose unadjuvanted, or standard dose adjuvanted). Data are currently not available for concomitant administration with other vaccines.
- See here for AREXVY Consumer Medicine Information: www.au.gsk.com/en-au/products/product-list/arexvy/
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 https://au.gsk.com/en-au/
Additional information
In relation to this GSK media announcement, no honorarium was provided to Professor Charlotte Hespe AM, Head of General Practice and Primary Care Research. They have been briefed by GSK on the use of this product.
Abbreviations
COPD, chronic obstructive pulmonary disease; RSV, respiratory syncytial virus; TGA, Therapeutic Goods Administration; NIP, National Immunisation Program.
For information on GSK products or to report an adverse event involving a GSK product, please contact GSK or Medical Information on 1800 033 109. Trademarks are owned by or licensed to the GSK group of companies ©2026 GSK group of companies or its licensor.
References
1 AREXVY Production Information. 2025
2 Kaler J et al. Cureus 2023;15(3):e36342.
3 Kodama F et al. Infect Dis Clin North Am 2017;31:767–90.
4 Varghese BM et al. Epidemiol Infect 2018;146(5):619–26.
5 Feldman C et al. Pneumonia (Nathan) 2025;17(1):15.
6 Geismar C et al. Sci Rep 2023;13(1):12511.
7 Tseng HF et al. J Infect Dis 2020;222(8):1298–1310
8 Agac A et al. Viruses 2023;15(10):1999.
9 Njue A et al. Open Forum Infect Dis 2023;10(11):ofad513.
10 Saravanos G; Med J Aust.;2019 210;447-453
11 Alfano F et al. Drugs Aging 2024;41(6):487–505.
12 Branche AR et al. Influenza Other Respir Viruses 2022;16(6):1151-60.
13 Ubamadu E et al. Infect Dis Ther 2024;13(7):1399-1417.
14 Di Giallonardo F et al. Viruses 2018;10(9):476
15 Obando-Pacheco P et al. J Infect Dis 2018;217(9):1356–64.
16 Paynter S et al. Aust N Z J Public Health 2015;39(1):8–10.
17 National Notifiable Disease Surveillance System. https://nindss.health.gov.au/pbi-dashboard/