ISSUE 4 AUGUST
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 23 June 2025.
Summary
In response to reports we [the TGA] have received about administration errors related to respiratory syncytial virus (RSV) prevention products, we are reminding prescribers and vaccination providers that each product is specifically indicated for different patient groups.
This article provides information about the indications for the individual products and how to avoid administration errors.
About RSV prevention products
Respiratory syncytial virus (RSV) infects most children by 2 years of age. RSV infection is associated with substantial disease burden, with acute lower respiratory tract infection due to RSV being a leading cause of hospitalisation for infants less than 12 months old. While most infants hospitalised with RSV disease are otherwise healthy, those with medical risk factors have an increased risk of severe disease.
RSV is also an important cause of respiratory disease and hospitalisation in older people, Aboriginal and Torres Strait Islander adults, and people with conditions that increase their risk of severe RSV disease [such as asthma and COPD].
A recent review in the Medical Journal of Australia described the introduction of new RSV preventatives as an ‘era‐defining advancement’.
In November 2024, the Australian Government announced that the maternal RSV vaccine, Abrysvo, would be available from 3 February 2025 to all eligible pregnant women at no cost [to the patient] under the National Immunisation Program (NIP). In parallel, Australian jurisdictions have targeted RSV programs that offer the monoclonal antibody Beyfortus (nirsevimab) to eligible newborns at no cost [to the patient]. Go here to download a fact sheet about the programs: Respiratory syncytial virus (RSV) products – Program advice for health professionals.
Vaccines provide protection by stimulating an immune response in which the body produces antibodies against an infectious agent, while a monoclonal antibody product provides similar antibodies directly. Maternal vaccination during pregnancy results in placental transfer of antibodies, conferring protection to newborns and infants.
Early studies suggest that the immunisation products have the potential to save many thousands of babies from being admitted to hospital in Australia each year. See Background section [in the full article] for more information on these risk reductions.
The new immunisation products:
- Arexvy is a vaccine used to prevent lower respiratory tract disease in individuals aged 60 years and older, or those aged 50–59 years who are at increased risk of RSV disease. Arexvy was approved by the TGA on 14 January 2024. [This vaccine is not recommended for pregnant women.]
- Abrysvo is a vaccine given to pregnant women to prevent lower respiratory tract disease caused by RSV in their infants from birth through to 6 months of age. It is also approved for use in individuals aged 60 years and older. As of 3 February 2025, Abrysvo has been funded for pregnant women between 28 and 36 weeks’ gestation under the NIP.
- Beyfortus (nirsevimab) is a human immunoglobulin monoclonal antibody given to infants and children to prevent RSV lower respiratory tract disease. Beyfortus (nirsevimab) is delivered through state and territory immunisation programs.
We have only considered the risks and benefits of each of these products for the groups listed in the approved indication and it is important that vaccine providers adhere to the guidelines in the Australian Immunisation Handbook.
About the administration errors
We have been receiving reports in 2025 of product administration errors related to RSV prevention products. An administration error generally occurs when one of these products is given outside the indications approved by the TGA. No adverse event was reported for most of the product administration error reports received by the TGA to date, but an administration error may lead to various problems, including unknown levels of protection for vaccine recipients.
For more information on these administration errors, see the Reports to the TGA section below [in the full article].
Vaccine errors are preventable, however the introduction of all 3 products with differing indications within a short period may be contributing to these errors. Issues with a lack of clarity in some prescribing software have recently been addressed.
The potential consequences of these errors could include inadequate immunological protection, cost impacts, inconvenience and reduced confidence in vaccination more broadly.
See the full article on the TGA website.
