ASID Special Interest Groups - ANZPID and VACSIG - call for equity in RSV prevention for Australia and New Zealand

The Australian and New Zealand Paediatric Infectious Diseases (ANZPID) Group and the Vaccination Special Interest Group (VACSIG) of the Australasian Society for Infectious Diseases (ASID)* calls for urgent consideration for equity in RSV prevention strategies for children across Australia and Aotearoa New Zealand.

Respiratory syncytial virus (RSV) is the leading cause for hospitalisation of children < 5 years in Australia and Aotearoa New Zealand (NZ). (1,2) Globally, one in every 50 deaths in children (<5 years) and one in every 28 deaths in young infants (aged 28 days to 6 months) is attributable to RSV. (3) Most children are infected by two years of age; young infants are at the highest risk of morbidity and mortality due to RSV infection and prematurely-born infants and infants with underlying medical conditions at greatest risk of severe RSV disease. (4)

Importantly, the majority of children hospitalised with RSV are otherwise well, with no pre-existing medical conditions.5 In Australia, Aboriginal and Torres Strait Islander children and in NZ, children of Māori or Pacific ethnicity are hospitalised with RSV at a rate of more than 2 times higher than the rest of the paediatric population. (2,6,7)

RSV bears a significant financial burden to the community. The annual RSV hospitalisation costs for children <5 years in Australia is estimated between 60 to 120 million dollars, (8) but indirect costs, particularly carer time away from work add an additional cost burden.  In addition, RSV infection in infancy is associated with ongoing health complications, including wheezing illnesses and asthma in children9 contributing an additional burden and cost for children, families and the community.

RSV also causes lower respiratory tract disease and hospitalisation in adults, with older adults with chronic medical conditions at particularly high risk of severe outcomes. (7,10) Prior to 2024 the only medical product available for infant RSV prevention was palivizumab, a short acting monoclonal antibody, administered via monthly injection for five months over the RSV season. (11) Palivizumab was never nationally funded in Australia and is only administered to a small group of very high-risk infants, and can be difficult to source. In NZ palivizumab was funded temporarily from late 2021 to 2023 for very high-risk infants, with no announcement of continued funding. (12)  

In 2024, several new prevention strategies to protect infants and adults from RSV disease have become available. Clinical trials of newly licensed vaccines in adults aged 60 years have demonstrated reduction in RSV chest infections by 70%. (13,14) In infants, where the largest burden lies, ‘passive’ immunisation by providing vaccination of mothers during pregnancy or administration of a single dose of the monoclonal antibody nirsevimab to infants has been shown to be highly effective in reducing the burden of RSV infection and hospitalisation in infants. (15,16) Real-world evidence from Europe and the United States has revealed promising effectiveness, leading to notable reductions (of over 80%) in RSV-related hospitalisations. (17,18)

In Australia, at the time of writing, a vaccine GSK RSVPreF3 (Arexvy) has been licensed for older adults; and a monoclonal antibody for infants, nirsevimab (Beyfortus), has been registered by the Therapeutics Goods Administration (TGA). 

We currently face a scenario where certain healthy babies, well past the newborn stage, will be administered doses of nirsevimab, while very high-risk infants at other jurisdictions will not be receiving any protection.

Despite RSV prevalence being comparable across Australian jurisdictions and in NZ, at the time of writing, no national preventative strategy for infants exists in either country. Western Australia was the first sub-national jurisdiction to announce funding for an infant nirsevimab program, (19) followed by New South Wales (20) and Queensland (21) and eligibility varies across each state-based program. We currently face a scenario where certain healthy babies, well past the newborn stage, will be administered doses of nirsevimab, while very high-risk infants at other jurisdictions will not be receiving any protection.

Differences in funding for immunisations among Australian states is not new. There are instances where one jurisdiction decides to take proactive measures and institute free vaccine programs for its population. Such initiatives can serve as catalysts, prompting other jurisdictions to adopt similar measures. In this case, a state of inequity exists, and ANZPID and VACSIG hopes other jurisdictions will consider adopting these RSV preventions for infants within their borders. There still remains a risk of inequity with this approach however, so a national approach within Australia and a similar national approach in NZ would be optimal. Western Australia's implementation of an influenza vaccine program for children aged 6 months to <5 years in 2008 but it took 10 years for other states and territories to fund the same program and a further 12 years for this vaccine program to be integrated into the National Immunisation Program (NIP) in 2020. (22) South Australia implemented a meningococcal B vaccine program in 2018 with New Zealand and Queensland launching their programs in 2023 and 2024 respectively. (23,24) Other Australian jurisdictions do not yet have funded meningococcal B program for healthy non-Aboriginal and Torres Strait Islander populations. This is despite meningococcal serogroup B being the leading cause invasive meningococcal disease across all jurisdictions. (25,26)

Today 10 countries (USA, UK, France, Spain, Luxembourg, Belgium, Switzerland, Ireland, Netherlands, Chile), the majority being high-income nations, have made RSV immunisation available for use in all infants to prevent infant RSV diseases. This uptake of RSV immunisation starkly contrasts with the distribution of RSV disease and especially mortality that occurs in low- and middle-income countries (LMIC): in 2019 it was estimated that 30 million episodes of RSV lower respiratory tract infection occurred in children aged 0-4 years with approximately 97% of global deaths occurring in LMIC.3 Notably, even countries who participated in clinical trials for RSV immunisations, such as South Africa and Brazil, still lack access to these products.

Paediatricians and Infectious Diseases physicians, represented by Australia and New Zealand Paediatric Infectious Diseases Group (ANZPID) and the Vaccination Special Interest Group (VACSIG) within the Australasian Society for Infectious Diseases (ASID) believe RSV prevention should be equitably provided across Australia and New Zealand.

ANZPID, VACSIG and ASID also support the World Health Organisation and Gavi initiative to work with manufacturers to ensure equitable access to immunisation strategies across LMICs.

References

1. Evohealth. Time to Act, Protecting our children from RSV, 2023.

2. Prasad N, Newbern EC, Trenholme AA, et al. Respiratory syncytial virus hospitalisations among young children: a data linkage study. Epidemiol Infect 2019; 147: e246.

3. Li Y, Wang X, Blau DM, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. The Lancet 2022; 399(10340): 2047-64.

4. Vartiainen P, Jukarainen S, Rhedin SA, et al. Risk factors for severe respiratory syncytial virus infection during the first year of life: development and validation of a clinical prediction model. The Lancet Digital Health 2023; 5(11): e821-e30.

5. Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med 2009; 360(6): 588-98.

6. Homaira N, Oei JL, Mallitt KA, et al. High burden of RSV hospitalization in very young children: a data linkage study. Epidemiol Infect 2016; 144(8): 1612-21.

7. Saravanos GL, Sheel M, Homaira N, et al. Respiratory syncytial virus-associated hospitalisations in Australia, 2006–2015. Medical Journal of Australia 2019; 210(10): 447-53.

8. Brusco NK, Alafaci A, Tuckerman J, et al. The 2018 annual cost burden for children under five years of age hospitalised with respiratory syncytial virus in Australia. Commun Dis Intell (2018) 2022; 46.

9. Rosas-Salazar C, Chirkova T, Gebretsadik T, et al. Respiratory syncytial virus infection during infancy and asthma during childhood in the USA (INSPIRE): a population-based, prospective birth cohort study. The Lancet 2023; 401(10389): 1669-80.

10. Branche AR, Falsey AR. Respiratory syncytial virus infection in older adults: an under-recognized problem. Drugs Aging 2015; 32(4): 261-9.

11. Therapeutic Goods Administration. SYNAGIS palivizumab (rmc) 100 mg / 1 mL solution for injection vial (231139). 2015. https://www.tga.gov.au/resources/artg/231139 (accessed 25 March 2024).

12. Pharmac Te Pataka Whaioranga. End of temporary funding of palivizumab for preventing RSV. 31 October 2023 2023. https://pharmac.govt.nz/news-and-resources/news/end-of-temporary-funding-of-palivizumab-for-preventing-rsv (accessed 23 March 2024).

13. Papi A, Ison MG, Langley JM, et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. New England Journal of Medicine 2023; 388(7): 595-608.

14. Walsh EE, Pérez Marc G, Zareba AM, et al. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. New England Journal of Medicine 2023; 388(16): 1465-77.

15. Kampmann B, Madhi SA, Munjal I, et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. New England Journal of Medicine 2023; 388(16): 1451-64.

16. Drysdale SB, Cathie K, Flamein F, et al. Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. New England Journal of Medicine 2023; 389(26): 2425-35.

17. Moline HL, Tannis A, Toepfer AP, et al. Early Estimate of Nirsevimab Effectiveness for Prevention of Respiratory Syncytial Virus-Associated Hospitalization Among Infants Entering Their First Respiratory Syncytial Virus Season - New Vaccine Surveillance Network, October 2023-February 2024. MMWR Morb Mortal Wkly Rep 2024; 73(9): 209-14.

18. López-Lacort M, Muñoz-Quiles C, Mira-Iglesias A, et al. Early estimates of nirsevimab immunoprophylaxis effectiveness against hospital admission for respiratory syncytial virus lower respiratory tract infections in infants, Spain, October 2023 to January 2024. Eurosurveillance 2024; 29(6): 2400046.

19. Government of Western Australia Department of Health. Respiratory Syncytial Virus (RSV) immunisation. 13 March 2024 2024. https://www.health.wa.gov.au/Articles/N_R/Respiratory-syncytial-virus-RSV-immunisation?utm_source=miragenews&utm_medium=miragenews&utm_campaign=news (accessed 24 March 2024).

20. NSW Health. Respiratory syncytial virus (RSV) prevention. 25 March 2024 2024. https://www.health.nsw.gov.au/immunisation/Pages/respiratory-syncytial-virus.aspx (accessed 25 March 2024).

21. Queensland Health. Queensland Paediatric Respiratory Syncytial Virus Prevention Program 25 March 2024 2024. https://www.health.qld.gov.au/clinical-practice/guidelines-procedures/diseases-infection/immunisation/paediatric-rsv-prevention-program (accessed 25 March 2024).

22. National Centre for Immunisation Research and Surveillance. History of Immunisation - Australia: Influenza November 2022 2022. https://ncirs.org.au/sites/default/files/2022-11/Influenza-history-November%202022.pdf (accessed 24 March 2024).

23. National Centre for Immunisation Research and Surveillance. History of Immunisation - Australia: Meningococcal. April 2023 2023. https://ncirs.org.au/sites/default/files/2022-11/Influenza-history-November%202022.pdf (accessed 24 March 2024).

24. Immunisation Advisory Centre. Meningococcal B (Bexsero) quick facts. 31 May 2023 2023. https://www.immune.org.nz/factsheets/menb-bexsero (accessed 25 March 2024).

25. Lahra MM, George CR, Van Hal S, Hogan TR. Australian Meningococcal Surveillance Programme Annual Report, 2022. Communicable Diseases Intelligence 2023; 47.

26. Burton C, Best E, Broom M, Heffernan H, Briggs S, Webb R. Pediatric Invasive Meningococcal Disease, Auckland, New Zealand (Aotearoa), 2004-2020. Emerg Infect Dis 2023; 29(4): 686-95.

 *No PBAC or ATAGI members were involved in drafting or endorsing the statement.

Media Contact: Alison Sweeney alison@asid.net.au or 0425 221 155.

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