Australia’s first RSV (respiratory syncytial virus) vaccine AREXVY approved by TGA

  • AREXVY has been approved by the Therapeutic Goods Administration (TGA) for Australians 60 and over to protect against lower airway infection caused by respiratory syncytial virus (RSV),*1 a contagious respiratory virus2
  • RSV infection typically peaks during the winter season in temperate climates in Australia3,4
  • In some cases, RSV can cause serious health complications in older adults, which can include pneumonia, respiratory failure and, in rare cases, even death2,5

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GSK Australia welcomes the TGA approval of AREXVY (respiratory syncytial virus vaccine, adjuvanted) to protect against lower airway disease caused by RSV in adults aged 60 years and over.*1 AREXVY is the first RSV vaccine to be approved for use in Australia.1  

RSV is a common and contagious respiratory virus2,6 that can cause cold- and flu-like symptoms in adults.2,5 RSV is often considered as an illness that mainly affects children,2,5 however RSV can also cause serious illness and in rare cases, even death, in older adults.7-9 Older adults with certain chronic medical conditions, including asthma, diabetes, chronic obstructive pulmonary disease (COPD) and congestive heart failure have a greater risk of being hospitalised from RSV compared with those without these conditions.†8,10,11

Symptoms of RSV in adults are often similar to other acute respiratory infections, like colds or influenza,2,5 including a blocked nose, cough, fatigue, fever, sore throat, runny nose, body aches and headache,2,5,9 and a test is needed to confirm a diagnosis.2

AREXVY, which has already been approved for use in the UK,12 the European Union,13 the US,14 Canada15 and Japan,16 is a protein-based vaccine given as a single dose.1

“RSV infection can have a significant impact on the health of older adults including those with existing medical conditions, which can add pressure onto our healthcare system. Most people view RSV as an illness that mainly affects children, and its impact on older adults, especially for those with underlying medical conditions, has fallen under the radar,” said Professor Robert Booy.

“Until now, RSV did not have a vaccine or specific treatment for older adults – this is a real step forward for public health and a turning point in our effort to reduce the impact of RSV,” added Professor Booy, Infectious Diseases Expert, University of Sydney Clinical School & Children's Hospital at Westmead.

“We’ve seen many older adults from our community suffering with RSV over the years, and it can be a challenging respiratory disease that deserves more attention and awareness in Australia,” said Catherine Hughes, Founding Director of Immunisation Foundation of Australia. “Supporting community immunisation is the founding principle of our organisation – so having a new vaccine is welcomed.”

Cases of RSV were only officially counted in Australia from 2021,17 so there are still gaps in fully understanding how common the disease is and what impact it has on the Australian population.7,18.

RSV is predominantly spread by inhaling airborne droplets from those with the infection, or through contact with contaminated surfaces,2,5 and is therefore capable of spreading rapidly within households.19 RSV infections typically peak during autumn and winter in temperate climates in Australia,3,4 alongside other respiratory viruses,5,20 however, RSV can be caught at any point throughout the year.3

“The availability of an RSV vaccine for adults aged 60 and over is the result of collaboration across academia, industry, and research centres.  I am excited to see this innovation now become available for older adults in Australia, including those with underlying health conditions, who carry a substantial burden of disease with RSV infection,” said Dr Alan Paul, Executive Country Medical Director, GSK Australia.

The TGA registration of AREXVY is based on the results of GSK’s international phase III clinical trial, which compared AREXVY with placebo in almost 25,000 people aged 60 years or older.1,21.

Older adults may consult with their Healthcare Professional for further information on RSV.

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Footnotes

*AREXVY is indicated for active immunisation of individuals 60 years and older for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV).1

†Based on population-based surveillance systems in New Zealand (retrospective analysis10) and the US (prospective study8 and retrospective analysis11) in adults ≥65 years.

 

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About AREXVY

Safety Information

Like all medicines, AREXVY can cause side effects. The most commonly reported side effects following administration of AREXVY are redness or swelling at the injection site, fever, chills, tiredness, headache, muscle pain, joint pain or a runny nose.1 Patients should speak to their doctor or pharmacist if they get any of the side effects listed above or if they notice any other side effects.22

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/​

In relation to this GSK media announcement, no honoraria were provided to Professor Robert Booy or Ms Catherine Hughes. They have been briefed by GSK on the TGA-approved use of the product.

Abbreviations

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

See here for AREXVY Consumer Medicine Information: www.au.gsk.com/en-au/products/product-list/arexvy/

References

  1. AREXVY Product Information.
  2. Kaler J et al. Cureus 2023;15(3):e36342.
  3. Di Giallonardo F et al. Viruses 2018;10(9):476.
  4. Obando-Pacheco P et al. J Infect Dis 2018;217(9):1356–64.
  5. Kodama F et al. Infect Dis Clin North Am 2017;31:767–90.
  6. Ching NS et al. J Paediatr Child Health 2018;54(12):1321-1328.
  7. Saravanos GL et al. Med J Aust 2019;210(10):447–53.
  8. Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.
  9. Tseng HF et al. J Infect Dis 2020;222(8):1298–1310.
  10. Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.
  11. Kujawski SA et al. PLoS One 2022;17(3):e0264890.
  12. Medicines and Healthcare Products Regulatory Agency (MHRA). Arexvy [accessed 2023 Dec 1]. Available from: products.mhra.gov.uk/search/?search=Arexvy
  13. European Medicines Agency (EMA). Arexvy [updated 2023 Jun 22; accessed 2023 Nov 30]. Available from: www.ema.europa.eu/en/medicines/human/EPAR/arexvy
  14. United States Food and Drug Administration (FDA). FDA approves first respiratory syncytial virus (RSV) vaccine [updated 2023 May 3; accessed 2023 Nov 30]. Available from: www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
  15. Government of Canada. Respiratory syncytial virus (RSV): Canadian immunization guide [updated 2023 Sep 8; accessed 2023 Nov 30]. Available from: www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html
  16. 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 [updated 2023 Sep 25; accessed 2023 Nov 30]. Available from: www.gsk.com/en-gb/media/press-releases/japan-s-ministry-of-health-labour-and-welfare-approves-gsk-s-arexvy
  17. Immunisation Coalition. Respiratory syncytial virus (RSV) statistics [updated 2023 Nov 27; accessed 2023 Nov 30]. Available from: www.immunisationcoalition.org.au/news-data/respiratory-syncytial-virus-rsv-statistics
  18. Nazareno AL et al. Influenza Other Respir Viruses 2022;16(6):1082–90.
  19. Otomaru H et al. Am J Epidemiol 2021;190:2536–43.
  20. Bloom-Feshbach K et al. PloS One 2013;8:e54445.
  21. Papi A et al. N Engl J Med 2023;388(7):595–608.
  22. AREXVY Consumer Medicine Information.

 

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