TGA approves Arexvy [Recombinant Respiratory Syncytial Virus (RSV) adjuvanted vaccine] for adults 50-59 years old at increased risk for RSV disease

  • The TGA has approved a new indication for AREXVY for use in adults 50 - 59 years of age who are at increased risk for RSV disease.1

  • Adults 50+ with chronic medical conditions - including COPD and asthma - are at increased risk of severe RSV and more likely to be hospitalised compared to those without these conditions.2,3,4,5

 

GSK Australia welcomes TGA (Therapeutic Goods Administration) approval of a new indication for AREXVY [Recombinant Respiratory Syncytial Virus pre-fusion F protein (RSVPreF3) (AS01E adjuvanted vaccine)] for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 50-59 years old and at increased risk for RSV disease.1 Chronic medical conditions that place this community at increased risk include chronic obstructive pulmonary disease (COPD), asthma, diabetes and heart failure.2,3,4,5  

AREXVY was the first RSV vaccine approved in Australia for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and over,1 and now is the first approved vaccine for adults aged 50-59 years old and at increased risk for RSV disease.1  

While RSV is a common and contagious respiratory virus2,6 often considered an illness that mainly affects children,2,7 it can also cause serious disease and in rare cases, even death, in older adults.8,9

Those with chronic medical conditions, including asthma, diabetes, chronic obstructive pulmonary disease (COPD) and congestive heart failure, have increased risk of severe RSV infection and are more likely to be hospitalised compared to those without these conditions.3,4,5 RSV hospitalisation rates in 50–64 year olds with COPD are 10x higher and with asthma 8x higher than those without chronic medical conditions.3

 RSV infection is a nationally notifiable disease and viewed by the Federal Government as a risk to public health - alongside influenza and COVID.10

In 2024, Australia experienced a record 175,786 cases of RSV nationwide, with over 41,000 cases in adults over 50, according to the National Notifiable Diseases Surveillance System.11

Between 2016 and 2019, there were more than 115,000 hospitalisations across all age groups with an RSV diagnosis.12

“RSV is generally viewed as a virus that largely affects young children, however, it can have a very significant impact in adults over 50, particularly those with existing medical conditions. Having a vaccine indicated for adults 50 through 59 years of age who are at increased risk for RSV provides Australian clinicians with an opportunity to address this important public health priority,” said Professor Charlotte Hespe AM. Head, General Practice and Primary Care Research, School of Medicine, Sydney.

Symptoms of RSV in adults are often similar to other acute respiratory infections, like colds or influenza,7,13 including a blocked nose, cough, fatigue, fever, sore throat, runny nose, body aches and headache.7,9,13 A test is needed to confirm a diagnosis.13

AREXVY is a protein-based vaccine which combines an antigen (RSV PreF3) with an adjuvant (AS01E) to induce an antigen-specific cellular response and neutralising antibodies that help protect against lower respiratory tract disease caused by RSV in older adults.1

Older adults may benefit from vaccines that enhance immune responses in the presence of age-related decline in immunity.14

The vaccine is given as a single dose and can be administered with any influenza vaccine in the same visit.1  

AREXVY is also available for use in the UK,15 the European Union,16 the US,17 Canada18 and Japan.19

“For adults over 50 who live with the challenges of chronic health diseases, like COPD and asthma, RSV can be extremely serious,” said Mark Brooke, CEO, Lung Foundation Australia. “Supporting this community by providing potential options against RSV for suitable patients is great news.”

RSV is predominantly spread by inhaling airborne droplets from those with the infection, or through contact with contaminated surfaces,7,13 and is therefore capable of spreading rapidly within households.20 RSV infections typically peak during autumn and winter in temperate climates in Australia,21,22 alongside other respiratory viruses,7,23 however, RSV can be caught at any point throughout the year.21

“We are extremely pleased AREXVY is now approved in Australia for 50 to 59 year old adults at increased risk for RSV disease. Ensuring these individuals can access vaccines against our most challenging viruses is our priority at GSK and broadening availability of our RSV vaccine is an important component of our commitment,” said Dr Alan Paul, Executive Country Medical Director, GSK Australia.

The TGA registration of AREXVY in 2024 was 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. This new indication for active immunisation for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 50 - 59 years of age, who are at increased risk of RSV disease, is based on the results from GSK’s clinical trial development program and is an extension of the indication for adults 60 years of age and older. 1,24.

 Patients should consult with their Healthcare Professional for further information on RSV.

 

 

ENDS

Cube Enquiries GSK Enquiries
Anne-Marie Sparrow Helena Sfelagis
anne-marie@cube.com.au helena.x.sfelagis@gsk.com
0417 421 560 0478 261 568

 

About AREXVY (respiratory syncytial virus vaccine recombinant, adjuvanted)

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 not listed on the PBS or the National Immunisation Program (NIP).

Safety: Very common adverse events (≥10%) are headache, myalgia, arthralgia, injection site pain and fatigue. Common adverse events (≥1%) are injection site erythema, injection site swelling, fever, chills and rhinorrhoea (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.

For further information, please refer to the Consumer Medicine Information 

 

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 Home | GSK AU

 

Abbreviations

COPD, chronic obstructive pulmonary disease; RSV, respiratory syncytial virus; TGA, Therapeutic Goods Administration.

 

References

  1. Arexvy Production Information. 2024
  2. Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.
  3. Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.
  4. Kujawski SA et al. PLoS One 2022;17(3):e0264890.
  5. McLaughlin JM, Khan F, Begier E, Swerdlow DL, Jodar L, Falsey AR. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022;9(7):ofac300. Published 2022 Jun 17. doi:10.1093/ofid/ofac300
  6. Ching NS et al. J Paediatr Child Health 2018;54(12):1321-1328.
  7. Kodama F et al. Infect Dis Clin North Am 2017;31:767–90.
  8. Saravanos GL et al. Med J Aust 2019;210(10):447–53.
  9. Tseng HF et al. J Infect Dis 2020;222(8):1298–1310.
  10. Immunisation Coalition. Respiratory syncytial virus (RSV) statistics. Available from: www.immunisationcoalition.org.au/news-data/respiratory-syncytial-virus-rsv-statistics
  11. National Notifiable Disease Surveillance System. https://nindss.health.gov.au/pbi-dashboard/ Accessed 28 February 2025.
  12. National Centre for Immunisation Research and Surveillance. https://ncirs.org.au/ncirs-fact-sheets-faqs-and-other-resources/respiratory-syncytial-virus-rsv-frequently-asked#:~:text=Almost%20all%20children%20experience%20at,these%20children%20were%20otherwise%20healthy Accessed 28 February 2025.
  13. Kaler J et al. Cureus 2023;15(3):e36342.
  14. Stephens LM et al. Vaccines (Basel) 2021;9(6):624.
  15. Medicines and Healthcare Products Regulatory Agency (MHRA). Arexvy . Available from: products.mhra.gov.uk/search/?search=Arexvy 
  16. European Medicines Agency (EMA). Arexvy. Available from: www.ema.europa.eu/en/medicines/human/EPAR/arexvy
  17. United States Food and Drug Administration (FDA). FDA approves first respiratory syncytial virus (RSV) vaccine. Available from: www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
  18. Government of Canada. Respiratory syncytial virus (RSV): Canadian immunization guide. Available from: www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html
  19. GSK. Japan’s Ministry of Health, Labour and Welfare approves GSK’s Arexvy, the country’s first respiratory syncytial virus (RSV) vaccine for older adults Available from: www.gsk.com/en-gb/media/press-releases/japan-s-ministry-of-health-labour-and-welfare-approves-gsk-s-arexvy
  20. Otomaru H et al. Am J Epidemiol 2021;190:2536–43.
  21. Di Giallonardo F et al. Viruses 2018;10(9):476.
  22. Obando-Pacheco P et al. J Infect Dis 2018;217(9):1356–64.
  23. Bloom-Feshbach K et al. PloS One 2013;8:e54445.
  24. Papi A et al. N Engl J Med 2023;388(7):595–608.

 

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