
The Therapeutic Goods Administration (TGA) has issued a medicines safety update regarding the administration of respiratory syncytial virus (RSV) prevention products. These products include the two vaccines, Arexvy® and Abrysvo®, and the monoclonal antibody nirsevimab (Beyfortus®).
As of 13 June 2025, the TGA has received 84 medication error reports involving the administration of these products outside their approved indications. While most cases did not result in adverse events, concerns remain about the level of protection provided to patients when these products are used incorrectly.
The TGA acknowledges that the introduction of three RSV preventative medicines, each with different indications, within a short timeframe may be contributing to these errors. To help reduce the risk of further incidents, the TGA recommends the following strategies:
- Education on the differences between RSV prevention products;
- Use of both generic and brand names when prescribing these products;
- Improving storage practices to better differentiate between adult and paediatric vaccines;
- Following recommended checking protocols; and
- Implementation of local risk mitigation strategies.
A summary of the approved indications for these three products is shown in Table 1.
Table 1. Summary of RSV preventative therapies
| Medication | Population for administration | Dose frequency | Immunity provided | ||
| ≤ 24 months | Pregnant women | ≥ 60 years | |||
| Arexvy® | No | No | Yes* | Once | Active |
| Abrysvo® | No | Yes | Yes | Once | Active |
| Nirsevimab | Yes | No | No | Once | Passive |
* Arexvy® is also approved for use in patients 50-59 years old who are at higher risk for RSV disease
References:
- Abrysvo® ([Recombinant Respiratory Syncytial Virus Pre-Fusion F Protein] Vaccine) Australian approved product information. Sydney: Pfizer. Approved June 2025.
- Arexvy (Recombinant Respiratory Syncytial Virus pre-fusion F protein) Australian approved product information. Abbotsford: GlaxoSmithKline. Approved March 2025.
- Beyfortus™ (Nirsevimab) Australian approved product information. Macquarie Park: Sanofi-Aventis. Approved April 2025.
- Department of Health, Disability and Ageing. Correct administration of RSV vaccine and antibody products: Medicines Safety Update. Woden: Therapeutic Goods Administration; 2025.
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