World's First RSV Vaccine For Older Adults Now Registered For Use In NZ

The registration of a new vaccine which took around 50 years to develop, is set to offer older Kiwis protection against RSV-associated lower respiratory tract disease for the first time.[1][2][3]

RSV is a common and highly contagious respiratory virus, often considered an illness that mainly impacts children and causes cold and flu-like symptoms. However, the disease can also cause serious illness and in some cases, even death, in older adults. Data shows the impact of RSV in adults aged 60 years and older is significant, resulting in over 470,000 hospitalisations and 33,000 deaths in high-income countries.[4][5][6][7][8][9][10][11][12]

Older adults with certain chronic medical conditions, including asthma, diabetes, chronic obstructive pulmonary disease (COPD) and congestive heart failure have an elevated risk of being hospitalised from RSV compared with those without these conditions.[13][14][15][16]

Maori, Pacific peoples and those living in lower socioeconomic areas also have a greater risk of hospitalisation from the disease.[17][18]

Symptoms of RSV in adults are often similar to other acute respiratory infections, like colds or influenza, including a blocked nose, cough, fatigue, fever, sore throat, runny nose, body aches and headache, and a test is needed to confirm a diagnosis.[19][20][21][22] 23

Arexvy is the world’s first respiratory syncytial virus (RSV) vaccine for older adults and has been registered for use in Australia, the UK, the European Union, the US, Canada and Japan. Research shows an estimated 24% of US adults aged 60+ have reported receiving a RSV vaccine.[23][24][25]

Trial data shows Arexvy has an overall efficacy of 82.6% against RSV-Lower Respiratory Tract Disease (LRTD).[26][27][28]

A 94.6% efficacy was observed against RSV-LRTD in adults aged 60 and over with underlying conditions such as heart disease or diabetes – the population that is associated with the majority of RSV hospitalisations.[29][30][31][32][33][34][35]

Nonetheless, as with other vaccines, the vaccine may not protect all recipients.[26]

The vaccine was granted priority assessment through its NZ registration process to ensure availability ahead of the winter season.[36] A funding application for Arexvy has also been submitted to Pharmac for their assessment.[37]

Brett Marett, GSK NZ medical director, says the NZ registration and consent to distribute is an important step closer to delivering New Zealand’s first vaccine for RSV to help protect adults aged 60+.[38][39]

“Until now, RSV was one of the major respiratory infectious diseases with no vaccine.[40][41][42][43]

“We welcome the NZ registration which will mean that older adults in New Zealand, including those who are most at risk of developing severe disease from RSV due to underlying health conditions, have the opportunity to receive a vaccine to help protect them for the first time. This is a major step forward from a public health perspective.[44][45][46][47]

“Arexvy has demonstrated high efficacy in clinical trials and we look forward to working with healthcare stakeholders to ensure those at high risk of severe RSV infection can access it,” he says.[48]

Older adults may consult with their healthcare professional for further information on RSV. The Arexvy vaccine will be available for private purchase from GP clinics from 1 May 2024. The most common side effects are injection site pain, fatigue, muscle pain, headache, and joint pain.[49][50]

Notes:

[1] Anderson LJ, Dormitzer PR, Nokes DJ, Rappuoli R, Roca A, Graham BS. Strategic priorities for respiratory syncytial virus (RSV) vaccine development. Vaccine. 2013 Apr 18;31 Suppl 2(Suppl 2):B209-15. doi: 10.1016/j.vaccine.2012.11.106. PMID: 23598484; PMCID: PMC3919153.

[2] New Zealand. 2024. Arexvy Gazettal - Consent to the Distribution of a New Medicine

[3] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.medsafe.govt.nz/Profs/Datasheet/a/Arexvyinj.pdf (Last accessed 23 April 2024).

[4] Cleveland clinic;2023;1;RSV in children and adults

[5] Kaler J et al. Cureus 2023;15(3):e36342.

[6] Kodama F et al. Infect Dis Clin North Am 2017;31:767–90.

[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] Savic M. et al. Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: A systematic literature review and meta-analysis. Influenza Other Respi Viruses. 2023;17:e13031.

[11] Estimated based on 2019 population

[12] GSK;Press release;2024;1-6 Australia's first RSV vaccine

[13] Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.

[14] Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.

[15] Kujawski SA et al. PLoS One 2022;17(3):e0264890.

[16] GSK;Press release;2024;1-6 Australia's first RSV vaccine

[17] Farquharson, K. A., Anthony, D. D., Menzies, R., & Homaira, N. (2024). Burden of respiratory syncytial virus disease across the lifespan in Australia and New Zealand: a scoping review. Public Health, 226, 8–16. https://doi.org/10.1016/j.puhe.2023.10.031

[18] Prasad N, Newbern EC, Trenholme AA, Thompson MG, McArthur C, Wong CA, Jelley L, Aminisani N, Huang QS, Grant CC. The health and economic burden of respiratory syncytial virus associated hospitalizations in adults. PLoS One. 2020 Jun 11;15(6):e0234235. doi: 10.1371/journal.pone.0234235. PMID: 32525898; PMCID: PMC7289360.

[19] Cleveland clinic;2023;1;RSV in children and adults

[20] Kaler J;Cureus;2023;15;1-17 10.1371/journal.pone.0234235. PMID: 32525898; PMCID: PMC7289360.

[21] Kodama F et al. Infect Dis Clin North Am 2017;31:767–90.

[22] Tseng HF et al. J Infect Dis 2020;222(8):1298–1310.

[23] GSK;Press release;2024;1-6 Australia's first RSV vaccine (v1.0)

[24] Venkatesan P;The Lancet;2023;4;e577 https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(23)00195-7/fulltext Accessed 23 April 2024

[25] Vaccination Trends—Adults. (n.d.). https://www.cdc.gov/respiratory-viruses/data-research/dashboard/vaccination-trends-adults.html#:~:text=The%20percent%20of%20the%20population%20reporting%20receipt%20of%20a%20flu,%25%20(22.8%2D25.1). (Last accessed 23 April 2024).

[26] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.medsafe.govt.nz/Profs/Datasheet/a/Arexvyinj.pdf (Last accessed 23 April 2024).

[27] Papi A;N Engl J Med;2023;388;595-608

[28] For adults aged 60 and older (96.95% CI, 57.89, 94.08; n=12,466)

[29] Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. doi: 10.1056/NEJMoa2209604. PMID: 36791160.

[30] Falsey AR;The New England Journal of Medicine;2005;352;1749-1759

[31] 94.6% efficacy (95% CI, 65.88, 99.87; n=4937)

[32] Feldman RG, Antonelli-Incalzi R, Steenackers K, Lee DG, Papi A, Ison MG, Fissette L, David MP, Maréchal C, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. Clin Infect Dis. 2024 Jan 25;78(1):202-209. doi: 10.1093/cid/ciad471. PMID: 37698366; PMCID: PMC10810713.

[33] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.medsafe.govt.nz/Profs/Datasheet/a/Arexvyinj.pdf (Last accessed 23 April 2024).

[34] Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.

[35] Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.

[36] AREXVY Medsafe Product Detail;2024;1-1. Available from https://www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=24590 (Last accessed 23 April 2024).

[37] PHARMAC AREXVY Proposal - Application Tracker;2024;1-5

[38] New Zealand. 2024. Arexvy Gazettal - Consent to the Distribution of a New Medicine

[39] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.medsafe.govt.nz/Profs/Datasheet/a/Arexvyinj.pdf (Last accessed 23 April 2024).

[40] Mosscrop L. et al. Respiratory syncytial virus after the SARS-CoV-2 pandemic — what next?.Nature Reviews Immunology. 22, 589–590 (2022)

[41] New Zealand. 2024. Arexvy Gazettal - Consent to the Distribution of a New Medicine

[42] Falsey A. et al. Respiratory Syncytial Virus Infection in Elderly and High-Risk Adults. N Engl J Med 2005; 352:1749-1759

[43] Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.

[44] New Zealand. 2024. Arexvy Gazettal - Consent to the Distribution of a New Medicine

[45] Branche AR et al. Clin Infect Dis 2022;74(6):1004–11.

[46] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.medsafe.govt.nz/Profs/Datasheet/a/Arexvyinj.pdf (Last accessed 23 April 2024).

[47] Prasad N et al. Clin Infect Dis 2021;73(1):e158–63.

[48] Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. doi: 10.1056/NEJMoa2209604. PMID: 36791160.

[49] Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrøm V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. doi: 10.1056/NEJMoa2209604. PMID: 36791160.

[50] GlaxoSmithKline New Zealand. AREXVY Data Sheet. GSK NZ; 2024. Available at https://www.medsafe.govt.nz/Profs/Datasheet/a/Arexvyinj.pdf (Last accessed 23 April 2024)

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