Mpox vaccination clinical resources: Managing vaccine administration errors or deviations
On this page
- Preamble
- What to do after an error or deviation is detected
- Type of administration errors and deviations: Guiding principles, recommended actions, and examples
Preamble
This guidance document is for health care providers. It offers an approach to managing the Imvamune vaccine that is administered in a manner that differs from the recommendations of the manufacturer as authorized by Health Canada and/or the National Advisory Committee on Immunization (NACI). These are referred to as vaccine administration errors or deviations. This document builds on guidance developed by:
Input was also received from the Canadian Immunization Committee and NACI Secretariat.
For complete NACI advice, consult:
- Smallpox and mpox vaccines: Canadian Immunization Guide
- NACI statements and publications: Smallpox and mpox vaccines
There is limited evidence to guide the management of these situations. This document provides guidance only. Note that provincial and territorial protocols may differ from this guidance document. Clinical judgment is necessary for making appropriate decisions regarding vaccine administration errors and deviations and may result in management decisions that differ from those outlined in this guidance.
Note that this document should be used only to manage errors or deviations that have already occurred. In order to prevent errors or deviations from occurring, please follow provincial/territorial guidance, the product monograph and recommendations from NACI statements and publications when administering Imvamune. Training, educational resources, policies and procedures and oversight are useful tools to support the prevention of errors and deviations.
The term "valid" in this document refers to a dose that is considered acceptable for the purposes of managing an error or deviation.
What to do after an error or deviation is detected
If an inadvertent vaccine administration error or deviation is found, health care providers should:
- inform the client of the vaccine administration error or deviation as soon as possible, and:
- explain any implications or recommendations for future doses, the possibility of local or systemic reactions and impact on the effectiveness of the vaccine (if applicable and as known)
- consider culture, age, cognitive ability, language spoken and other diversity markers when communicating with the client
- if the client is a child, inform the parents or guardians and the child as appropriate
- document the error or deviation in the client's medical record
- report all errors, deviations, or near-miss incidents in accordance with the reporting processes of the institution, professional body or province or territory, and may also:
- report errors or deviations to the Canadian Medication Incident Reporting and Prevention System (CMIRPS)
- complete the adverse events following immunization (AEFI) reporting form (or your jurisdiction's form) and submit it to the local public health authority if an inadvertent vaccine administration error or deviation results in an AEFI
- determine how the vaccine administration error or deviation occurred and implement strategies to prevent it from happening again
As with usual practice, when managing errors and deviations, inquire about the client's history of adverse events following previous Imvamune vaccination(s). If they experienced a significant local or systemic reaction, make your decision to offer a subsequent dose on a case-by-case basis, in consultation with an allergist, immunologist or another appropriate physician as indicated.
Refer to the Canadian Immunization Guide smallpox and mpox vaccine chapter for information on vaccine administration (including concurrent vaccine administration), safety and adverse events.
Serologic testing to assess vaccine-induced immunity is not recommended to respond to errors or deviations in vaccine administration.
For other resources on vaccine administration practices, please consult the Canadian Immunization Guide.
Type of administration errors or deviations: Guiding principles, recommended actions, and examples
Site or route errors
Guiding principles
Imvamune is generally administered subcutaneously, with the recommended sites being the area over the triceps or the anterolateral thigh. In case of vaccine shortages, the intradermal route can also be used.
See the route, site and technique for vaccine administration in the vaccine administration practices: Canadian Immunization Guide chapter.
See dose, route of administration and schedule in the smallpox and mpox vaccines: Canadian Immunization Guide chapter.
Incorrect sites and routes are considered valid if an appropriate dose was used.
Examples
Incorrect site
If a site other than the area over the triceps or anterolateral thigh is used for subcutaneous administration:
- Do not repeat dose.
- Inform the recipient (and parent or guardian) of the error or deviation and of the potential for local and systemic adverse events.
Incorrect route
If an incorrect route (for example, intramuscular administration) was used with the correct dose (0.5 mL):
- Do not repeat dose.
- Inform the recipient of the potential for local and systemic adverse events.
If an incorrect route with a lower than recommended dose was used, see section below ("A dose that is lower than recommended administered by a route other than the subcutaneous route").
Dose errors: Too high a dose, too low a dose, or an unknown dose that is likely to be lower than the authorized dose
Guiding principles
- The dose for Imvamune is 0.5 mL given subcutaneously. In case of vaccine shortages, 0.1 mL dose administered intradermally can also be used for the second dose. Note: errors related to intradermal administration will not be the focus of this document as there is no current shortage of Imvamune in Canada and therefore the intradermal administration of the vaccine is not recommended.
- Doses that are too high are considered valid.
- Doses that are too low should be repeated.
- If the subcutaneous dose is known and can be repeated on the same clinic day, the remainder of the dose can be administered on that day.
- If the dose cannot be repeated on the same clinic day, or is unknown, or was given by a route other than the subcutaneous route, the full dose should be repeated as soon as possible.
- If repeating the dose on the same clinic day, preferably use a separate anatomical site (for example, opposite limb). If use of an opposite limb is not possible, the repeat dose should be given at least 2.5 cm (1 inch) from the previous dose.
- If repeating a dose after the original clinic day, any appropriate injection site can be used.
Interval errors
Guiding principles
Although Imvamune is a live-attenuated vaccine, it does not replicate, and for the purposes of spacing between doses, can be considered similar to non-live vaccines.
Recommended interval: NACI has recommended that the second dose of Imvamune should be given at least 28 days (4 weeks) after the first dose.
Second dose given at less than 28 days after the first dose: PHAC has recommended that if the vaccine series has been administered with an interval of 23 days or less, the second dose should be considered invalid and repeated at least 28 days from the invalid dose.
Second dose given more than 28 days after the first dose: Both doses are valid. There is no need to restart or add doses to the series if there is an extended interval between doses.
Concurrent administration
Guiding principles
Although Imvamune is a live-attenuated vaccine, it does not replicate and can be considered similar to non-live vaccines. NACI recommends that Imvamune can be given concurrently (i.e., same day) or at any time before or after other live or non-live vaccines. Therefore, all doses are considered valid if Imvamune is given concurrently or at any time before or after, any other vaccine. If concurrent administration with another vaccine is indicated, each vaccine should be administered in a different anatomic site (e.g., different limb or if a different limb is not possible give at least 2.5 cm or 1 inch apart) with separate injection equipment.
Refer to NACI Rapid Response: Updated interim guidance on Imvamune in the context of ongoing monkeypox outbreaks and the Canadian Immunization Guide (CIG) chapter on Smallpox and mpox vaccines.
Storage and handling errors
Guiding principles
Storage and handling errors or deviations for vaccines already administered require individual considerations based on the circumstances, in consultation with the manufacturer and local public health officials and based on clinical judgment. Note that this document is not intended to provide advice on products that have not yet been administered. For this information, see the detailed information on storage and handling provided on the following website, including allowable excursions: Imvamune vaccine: Storage temperatures, shelf life, shipment, supportive temperature excursion information.
In addition to information from the manufacturer, other factors to consider in deciding whether a dose requires repeating and when it should be repeated include:
- How substantial was the deviation? (for example, how long was the product exposed to an inappropriate temperature and what was the temperature deviation? How long after the expiry date was the vaccine used?)
- Were there any other errors or deviations in the client's previous dose?
- What are the client's underlying health or disease related risk factors for serious disease or a less than an optimal response to the vaccine (for example, age and immunocompromising conditions)?
- Has the client had any significant adverse events after the previous dose?
Detailed information on storage and handling, including allowable excursions, is provided on the following website: Imvamune vaccine: Storage temperatures, shelf life, shipment, supportive temperature excursion information. Use following an exposure of any length of time (except for rapid storage change from freezer to refrigerator and preparation of the product for administration) at or above 20°C is not supported.
In consultation with the manufacturer and local public health officials, if the dose is felt to exceed allowable storage and handling conditions and recommended expiry dates and available information supports that the dose may not be potent or there is no information to support its potency, the dose should be considered invalid and repeated.
- The repeat dose could be offered as soon as possible or up to 28 days after the invalid dose, based on clinical judgement of the extent of the excursion and ongoing risk of exposure.
When repeating a dose after an invalid dose:
- If the repeat dose is given on the same clinic day, preferably use a separate anatomical site (for example, opposite limb). If use of an opposite limb is not possible, the repeat dose should be given at least 2.5 cm (1 inch) from the previous dose.
- If repeating the dose after the original clinic day, any appropriate injection site can be used.
- The client should be advised of the potential for local and systemic adverse events.
Related links
U.S. Centers for Disease Control and Prevention (CDC):