Correct administration of RSV vaccine and antibody products

Summary

In response to reports we 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.

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 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. 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 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.
• 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.

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.

What health professionals should do

Note the indications for the different products and the circumstances of the administration errors outlined above.

Personnel at vaccination sites should undertake careful planning to prevent errors in prescribing, dispensing and administering RSV prevention products. Strategies include:

• Educating and training vaccination providers about the differences between RSV immunisation products.
• Using both the generic and brand name when prescribing immunisation products.
• Improving storage practices, such as storing immunisations for different cohorts on separate shelves or in different tubs within vaccine fridges; using fridge basket stickers; attaching colour-coded labels to differentiate between vaccines for adults and children.
• Following recommended administration practices by checking the correct product (including product name and indication), person (including patient’s age) and time (patient eligibility) for the immunisation.
• Using local risk mitigation strategies – for example the NSW Health Safety Notice Potential for error: RSV immunisation product and the Melbourne Vaccine Education Centre’s Vaccine administration error alert: Incorrect RSV prevention product for Victoria.

If an error does occur:

• clinical guidance on RSV immunisation product administration errors, including advice regarding the need for repeat doses, is available at: National Centre for Immunisation Research and Surveillance
• you can report the event either through your state or territory health department or directly to us.

All doses of immunisation products should be reported to the Australian Immunisation Register.

Background on RSV immunisation effectiveness

Recent Australian studies have shown exceptional effectiveness for the RSV immunisation products, even before reaching 90% coverage of the target population.

An article in the Journal of Infection from April 2025 described the adjusted estimate of Beyfortus (nirsevimab) effectiveness against RSV-associated hospitalisation in Western Australia as 88.2% for the 2024 RSV season.

A review in the Medical Journal of Australia (MJA) in May 2025 also described data from Western Australia where approximately 71% of eligible infants under one year of age received Beyfortus (nirsevimab) prior to or during the RSV season. RSV‐related hospital admissions were 57% lower than forecast predictions, corresponding to 505 fewer hospitalisations.

In Queensland, RSV‐related hospitalisations among infants under 6 months of age decreased by 69% compared to the previous year, equating to one fewer hospitalisation per day in the early months of rollout, with projections suggesting that this figure could rise to 3 hospitalisations prevented per day by the end of the year.

The MJA article also describes data emerging from Galicia, Spain, one of the pioneering regions to incorporate Beyfortus (nirsevimab) into its immunisation program. With a high coverage rate of 91.7% among 10,259 eligible infants, the program in Galicia reported an estimated 89.8% reduction in RSV‐related hospital admissions.

Reports to the TGA

As of 13 June 2025, there have been:

• 24 medication error reports of Arexvy being given in pregnancy
• 24 reports of Abrysvo being administered to children less than 12 months old
• 36 reports of Beyfortus (nirsevimab) being administered to females aged 15–54 years.

For the reports of Arexvy being given during pregnancy, we had received 5 reports where an adverse event was also reported following vaccination. These events included fatigue, lethargy, pain at the vaccination site, shortness of breath and a single report of chest pain.

For Abrysvo being given to newborns and infants, we had received 4 reports with adverse events that included irritability, sleepiness, fever and rash; a single report of vomiting; and a single report where the baby had an increased heart rate and increased breathing rate.

For the reports of Beyfortus being given to pregnant women, aside from the error itself, we have not received any report to date that details the patient suffering an adverse event.

Relevant literature

• Australian Immunisation Handbook
• National Immunisation Program schedule
• Australian Prescriber. RSV: an update on prevention and management

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

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Medicines Safety Update is written by staff from the Pharmacovigilance Branch.

• Editor: Dr Daniel Dascombe
• Deputy Editor: Aaron Hall.