Table. Clinical guidance on RSV immunisation product administration errors
Advice on the management of a range of possible RSV immunisation product administration errors is listed below.
An RSV immunisation product administration error occurs when one of these products – either an RSV vaccine or an RSV-specific monoclonal antibody – is given outside the current clinical recommendations.
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. See Reporting AEFIs and follow the advice in the Repeat dose recommendation column of the table
- 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 am–5 pm).
| Type of error | Administration error | Repeat dose recommendation |
|---|---|---|
| Site/route | Incorrect site (i.e. site other than deltoid or anterolateral thigh) | Do not give a repeat dose. |
| Incorrect route (i.e. subcutaneous or intradermal) | Do not give a repeat dose. | |
| Incorrect immunisation product | Abrysvo or Arexvy vaccine administered to an infant or young child recommended to receive nirsevimab (monoclonal antibody) |
Monitor for adverse events. Administer a dose of nirsevimab. This can be administered anytime from immediately after the error. |
| Arexvy administered to a pregnant woman recommended to receive Abrysvo |
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. |
|
| Immunisation product not clinically indicated |
Product administered to a person who is of appropriate age but is not clinically indicated to receive the product. Examples include:
|
Monitor for adverse events. |
| Incorrect age |
Abrysvo or Arexvy administered to a person who is younger than the approved age registered for that vaccine. Examples include:
|
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. |
| Nirsevimab administered to a person aged above 2 years, including during pregnancy |
Monitor for adverse events. If the person is recommended to receive Abrysvo or Arexvy, administer a dose of the correct product. This can be administered anytime from immediately after the error. For pregnant women who receive Abrysvo following inadvertent nirsevimab administration, if the Abrysvo dose is received:
|
|
| Abrysvo administered to a pregnant woman before 28 weeks gestation |
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 |
|
| Higher than approved dose | Higher than approved dose of correct formulation administered (e.g.100mg given to an infant weighting < 5kg) |
Monitor for adverse events. Do not give a repeat dose. |
| Lower than approved dose | Lower than approved dose or unknown dose of correct formulation administered |
If less than half of the vaccine / monoclonal antibody recommended dose (estimated) was administered, give a repeat dose. This can be administered anytime from immediately after the error. If half or more than half of the vaccine / monoclonal antibody recommended dose (estimated) was administered, OR the dose was unknown do not repeat the dose. If the unknown dose was Abrysvo given during pregnancy, consider a dose of nirservimab for the infant. |
| Immunising products administered after incorrect storage and/or handling | Temperature excursions / cold chain breaches |
Assess the impact of temperature excursion on the stability and potency of the immunising product on a case-by-case basis to decide whether a repeat dose is needed. Contact state or territory immunisation health services. See Cold chain breaches |
| Immunising product administered past the expiration or use-by date | Contact state or territory immunisation health services. See Cold chain breaches | |
| Incorrect reconstitution of immunisation product (e.g. diluent only) | Give a repeat dose as soon as possible. | |
| Multiple doses |
More doses administered than recommended by the relevant schedule. Examples include:
|
Monitor for adverse events. As new recommendations for schedules emerge, consider all doses given. |