New ATAGI advice to prevent RSV vaccination errors

The Australian Technical Advisory Group on Immunisation (ATAGI) has made an unusual move by issuing a statement on RSV vaccination errors.

There have been numerous reports to the Therapeutic Goods Administration (TGA) of RSV vaccines being administered to the wrong patient. 

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.

This includes the administration of Arexvy to a 7-week-old infant – instead of the infant-approved RSV immunisation nirsevimab (Beyfortus) – in a GP surgery in Sydney’s inner west.

‘I googled the vaccine she had given him … and it’s not approved for babies, and I just burst into tears,’ first-time mother Freya said. ‘She told us to go home, and everything would be OK.’

Pharmacists are providing an increasing share of RSV vaccines (12.51%), with over 30,000 vaccines administered.

The TGA advised Australian Pharmacist that 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, cost impacts, inconvenience, and reduced confidence in vaccination more broadly,’ the TGA spokesperson said.

AP explains what to do in the event of an error and how to ensure it doesn’t happen again.

What should I do if the wrong vaccine is administered?

At this stage, pharmacists cannot authorise and administer nirsevimab for infants. Should pharmacists inadvertently administer the wrong RSV vaccine to a pregnant person or other patients including older Australians, ATAGI has provided step-by-step advice on what to do next.

First things first; pharmacists have a duty to inform the recipient of the vaccine error and monitor for adverse effects.

‘It is important that health practitioners note the indications for the different products and the circumstances of the administration errors outlined above,’ the TGA spokesperson said.

Depending on the vaccine administered, pharmacists should follow clinical guidance on RSV immunisation product administration errors.

‘Clinical guidance on RSV immunisation product administration errors, including advice regarding the need for repeat doses, is available in the Australian Immunisation Handbook,’ the TGA spokesperson said.

For example, should Arexvy be administered to a pregnant patient, Abrysvo must not be provided in the current pregnancy. Arexvy given during pregnancy is expected to provide some protection for the infant. A dose of nirsevimab for the infant, either at birth or before their first RSV season, may be considered to ensure adequate protection.

Pharmacists must also report the vaccination error as an adverse event – whether or not any symptoms are apparent – to the relevant state or territory health department or directly to the TGA.

The National Centre for Immunisation Research and Surveillance NCIRS also advises reviewing how the error occurred and implementing procedures to ensure it doesn’t happen again.

And if a dose is considered invalid but has already been entered into the Australian Immunisation Register, pharmacists may need to notify AIR.

What can I do to prevent future errors?

Personnel at vaccination sites should undertake careful planning to prevent errors in prescribing, dispensing and administering RSV prevention products, the TGA spokesperson said.

ATAGI strongly recommends immunisation providers and supporting staff put strategies in place to make sure the correct RSV vaccine is chosen.

This includes labelling storage areas or trays for indicated populations, such as pregnant people and older adults. It’s advisable to store vaccines intended for infants and children in separate sections of the vaccine refrigerator. 

Reminders or warning signs should also be displayed in the pharmacy’s consultation room and/or vaccine storage area to keep potential vaccination errors front of mind.

In terms of workflow changes, pharmacists should implement a procedure checklist for selecting the correct vaccine for administration to specific population groups, such as pregnant people.

Pharmacists are also advised to regularly check for and install updates in clinical practice software systems, enabling alert functions where available to reduce the risk of administration errors.