Australia has added the RSV vaccine Arexvy to its National Immunisation Program (NIP) for adults aged 60 and over, following regulatory approval by the Therapeutic Goods Administration (TGA) and a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI). The move aims to reduce severe lower respiratory tract disease caused by respiratory syncytial virus (RSV), a leading cause of pneumonia and hospitalisation in older adults, particularly during winter months. This public health initiative reflects growing recognition of RSV’s significant burden on ageing populations and healthcare systems.
In Plain English: The Clinical Takeaway
- The RSV vaccine helps protect older adults from serious lung infections that can lead to hospitalisation.
- It is now available free under Australia’s NIP for people aged 60 and older, with priority given to those with chronic heart or lung conditions.
- Like other vaccines, it may cause mild side effects such as soreness at the injection site or fatigue, but serious reactions are rare.
Understanding RSV and the Need for Vaccination in Older Adults
Respiratory syncytial virus (RSV) is a common respiratory pathogen that typically causes mild, cold-like symptoms in healthy individuals but can lead to severe bronchiolitis and pneumonia in vulnerable populations, including infants, immunocompromised persons, and adults aged 60 and over. In older adults, RSV infection is associated with exacerbations of underlying chronic conditions such as chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF), significantly increasing the risk of hospitalisation and mortality. According to recent epidemiological modelling, RSV accounts for approximately 177,000 hospitalisations and 14,000 deaths annually among adults aged 65 and older in high-income countries.
The immune response to RSV weakens with age, a phenomenon known as immunosenescence, reducing the body’s ability to neutralise the virus upon reinfection. Unlike influenza, for which annual vaccination is standard, no RSV vaccine was broadly available for older adults until recently, leaving a significant gap in preventive care for an ageing population.
How the RSV Vaccine Works: Mechanism of Action and Clinical Evidence
The vaccine now included in Australia’s NIP, Arexvy (RSVPreF3), is a recombinant adjuvanted vaccine that contains a stabilised prefusion F glycoprotein of RSV subtype A, combined with the AS01E adjuvant system. This antigen is designed to elicit a strong neutralising antibody response against the RSV fusion protein, which the virus uses to enter host respiratory epithelial cells. By blocking this mechanism of action, the vaccine prevents viral fusion and subsequent infection.
Arexvy’s approval was based on data from the Phase III, double-blind, placebo-controlled AReSVi-006 trial (NCT04886596), which enrolled approximately 25,000 adults aged 60 and older across 17 countries, including Australia, the United States, and several European nations. Over a median follow-up of 10.4 months, the vaccine demonstrated 82.6% efficacy (95% CI: 57.9–94.1) against RSV-associated lower respiratory tract disease (LRTD) defined by two or more symptoms, and 94.1% efficacy against severe LRTD requiring oxygen supplementation or mechanical ventilation.
“The AReSVi-006 trial provides robust evidence that a single dose of Arexvy offers substantial protection against symptomatic RSV disease in older adults, with particularly strong protection against severe outcomes that drive hospitalisation.”
Geo-Epidemiological Bridging: Impact on Regional Healthcare Systems
Australia’s decision to fund the RSV vaccine through the NIP aligns with similar recent recommendations by the U.S. Centers for Disease Control and Prevention (CDC) and the European Medicines Agency (EMA), which have endorsed Arexvy and another RSV vaccine, Abrysvo (PF-06928316), for use in adults aged 60 and over. In the United States, the CDC’s Advisory Committee on Immunisation Practices (ACIP) recommends shared clinical decision-making for RSV vaccination in this age group, while in the UK, the Joint Committee on Vaccination and Immunisation (JCVI) is evaluating cost-effectiveness for potential inclusion in the NHS immunisation schedule.
By incorporating the RSV vaccine into the NIP, Australia ensures equitable access for older adults, particularly those in rural and remote areas where respiratory infections can lead to delayed care and poorer outcomes. The vaccine will be administered through general practitioners, pharmacies, and Aboriginal Community Controlled Health Services, reinforcing existing immunisation infrastructure. Modelling by the National Centre for Immunisation Research and Surveillance (NCIRS) estimates that achieving 60% vaccine coverage in adults aged 60 and over could prevent approximately 8,000 hospitalisations and 500 deaths annually in Australia.
Funding, Development, and Bias Transparency
The AReSVi-006 trial was sponsored by GSK (GlaxoSmithKline), the manufacturer of Arexvy. Funding for the trial came exclusively from GSK, which also provided the vaccine and placebo used in the study. Independent statistical analysis was conducted by a third-party contract research organisation, and the trial was overseen by an independent data monitoring committee (IDMC). Peer-reviewed publication of the trial results in the New England Journal of Medicine included full disclosure of funding sources and author affiliations, with several authors reporting financial ties to GSK as employees or shareholders.
To maintain scientific integrity, regulatory approval by the TGA and recommendation by ATAGI were based on a comprehensive review of publicly available trial data, manufacturing quality, and post-marketing safety surveillance plans. ATAGI’s recommendation emphasised that the benefit-risk profile favour vaccination in adults aged 60 and over, particularly those with comorbidities such as chronic lung disease, cardiovascular disease, or diabetes.
Contraindications & When to Consult a Doctor
The RSV vaccine Arexvy is contraindicated in individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including the AS01E adjuvant. It should be administered with caution in persons with moderate to severe acute illness; vaccination may be delayed until recovery. There are no data on use in pregnant or breastfeeding women, and the vaccine is not currently recommended for individuals under 60 years of age outside of clinical trials.
Common side effects include pain, redness, or swelling at the injection site (reported in >60% of recipients), fatigue, muscle pain, headache, and joint pain, typically resolving within a few days. Serious adverse events such as atrial fibrillation were observed in a compact number of trial participants but were not found to be statistically significant compared to placebo. But, individuals with a history of Guillain-Barré Syndrome (GBS) should consult their physician before vaccination, as a potential—though unconfirmed—association has been noted with other adjuvanted vaccines.
Patients should seek immediate medical attention if they experience symptoms of a severe allergic reaction, such as difficulty breathing, swelling of the face or throat, or rapid heartbeat following vaccination.
References
- Falsey AR, et al. Respiratory Syncytial Virus Vaccine in Older Adults. N Engl J Med. 2022;386:167-177. DOI: 10.1056/NEJMoa2110785.
- Australian Technical Advisory Group on Immunisation (ATAGI). Statement on the use of RSV vaccine in older adults. Australian Government Department of Health and Aged Care; 2025.
- National Centre for Immunisation Research and Surveillance (NCIRS). Modelling the impact of RSV vaccination in older Australians. Sydney: University of Sydney; 2024.
- Centers for Disease Control and Prevention (CDC). Use of RSV Vaccines in Older Adults: Advisory Committee on Immunisation Practices (ACIP) Recommendations. MMWR Recomm Rep. 2023;72(No. RR-4):1-24.
- European Medicines Agency (EMA). Arexvy: EPAR – Product Information. Amsterdam: EMA; 2022.
