NCIRS clinical guidance on RSV immunisation product administration errors

Last updated: 14 August 2025

What to do when an error occurs

When an RSV immunisation product administration error occurs, follow these steps:

• Inform the recipient (in keeping with the principle of open disclosure).
• Report the error as an adverse event, even if no adverse event has occurred. You can do this either through your state or territory health department or directly to the Therapeutic Goods Administration at www.tga.gov.au/reporting-problems.
• Follow the advice in the ‘Repeat dose recommendation’ column of the table above.
• Continue as per the relevant RSV immunisation schedule, unless otherwise indicated.
• Review how the error occurred and, if required, implement procedures to prevent it from happening again.

Monitoring should occur for any possible adverse event following immunisation.

Note: If a dose is deemed to be invalid but has already been entered into the Australian Immunisation Register (AIR), you may need to advise the AIR. The best way to do this is by calling 1800 653 809 (Monday–Friday, 8 a.m.–5 p.m.). 

Monitor for adverse events. 

Administer a dose of nirsevimab. This can be done anytime from immediately after the error. 

Do not give Abrysvo during current pregnancy.

Arexvy given during pregnancy is expected to provide protection to the infant; however, a dose of nirsevimab to the infant, either at birth or before their first RSV season, may be considered.

Product administered to a person who is of appropriate age but is not clinically indicated to receive the product. 

Examples include:

• nirsevimab given to an infant who is already adequately protected by maternal vaccination
• nirsevimab given to an infant who is in their second RSV season and is not recommended to receive a second-season dose

Abrysvo or Arexvy administered to a person who is younger than the approved age registered for that vaccine. Examples include:

• Abrysvo given to a non-pregnant person aged under 60 years
• Arexvy given to a person aged under 50 years

Monitor for adverse events.

Do not give a repeat dose at the scheduled age. The need for further doses has not been established; further advice will be given when data are available.

See ‘Incorrect immunisation product’ above for Arexvy inadvertently administered to a pregnant woman.

Monitor for adverse events.

If the person is recommended to receive Abrysvo or Arexvy, administer a dose of the correct product as soon as feasible. This can be done anytime from immediately after the error.

For pregnant women who receive Abrysvo following inadvertent nirsevimab administration, if the Abrysvo dose is received:

• at least 2 weeks before the infant’s birth, nirsevimab is not recommended for the infant.

• less than 2 weeks before the infant’s birth, nirsevimab is recommended for the infant.

Monitor for adverse events.

Do not give a repeat dose at the recommended gestational age.

If administered before registered gestation (24 weeks), consider a dose of nirservimab for the infant.

Monitor for adverse events.

Do not give a repeat dose.

If less than half of the vaccine/monoclonal antibody recommended dose (estimated) was administered, give a repeat dose as soon as feasible. This can be done anytime from immediately after the error.

If half or more than half of the vaccine/monoclonal antibody dose (estimated) was administered, do not repeat the dose.

If the unknown dose was Abrysvo given during pregnancy, consider a dose of nirservimab for the infant.

Assess the impact of temperature excursion on the stability and potency of the immunisation product on a case-by-case basis to decide whether a repeat dose is needed.

Contact state or territory immunisation health services. See State and territory immunisation cold chain breach contact numbers.

More doses administered than recommended by the relevant schedule. Examples include:

• repeat doses of RSV vaccine given
• infant inadvertently given a second dose of nirsevimab.

Monitor for adverse events.

As new recommendations for schedules emerge, consider all doses given.