Quick reference guide on use of COVID-19 vaccine for children 5 to 11 years of age: Managing vaccine administration errors or deviations

This section offers an approach to managing COVID-19 vaccines that are 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:

We also received input from the Canadian Immunization Committee and NACI.

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 in certain situations may also result in management decisions that differ from those outlined in this guidance.

Note also that this document is to be used only to manage errors or deviations that have already occurred. Please follow the product monographs and recommendations from NACI when administering COVID-19 vaccines. Note that criteria used to assess international travellers at the border may differ from this document as they are intended for different purposes.

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 parents/guardians and child of the vaccine administration error or deviation as soon as possible
- explain any implications or recommendations for future doses, 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 factors when communicating with the client
report all errors, deviations or near-miss incidents in accordance with the institutional medication error or professional body’s reporting process
- may also report errors or deviations to the Canadian Medication Incident Reporting and Prevention System (CMIRPS)
complete the jurisdiction’s Adverse Event Following Immunization (AEFI) form and submit it to the local public health authority if the inadvertent vaccine administration error or deviation results in an AEFI
- find information on AEFI reporting on the AEFI page
determine how the vaccine administration error or deviation occurred and implement strategies to prevent it from happening again

Serologic testing to assess vaccine-induced immunity following COVID-19 vaccine errors or deviations is generally not recommended. Health care providers are encouraged to contact their local public health authority and/or their provincial or territorial public health laboratory for advice if considering using serology to investigate an error or deviation.

For other resources on vaccine administration practices, please consult the Canadian Immunization Guide.

Type of administration errors or deviations and recommended actions

Table 4. Types of administration errors and recommended actions for each error
Type	Administration error or deviation	Interim guidance on how to consider the dose and recommended action
Site/route	Incorrect site (site other than the deltoid muscle [preferred site] or anterolateral thigh [alternate site])	Consider this a valid dose Inform the parent/guardian and child of the error or deviation and the potential for local and systemic adverse events and that the dose is acceptable
Site/route	Incorrect route (for example, subcutaneous)	Consider this a valid dose Inform the parent/guardian and child of the error or deviation and potential for local and systemic adverse events and that the dose is acceptable
Age	Dose or product administered to a client who is younger than the minimum age authorized by Health Canada to receive the product includes children 5 to 11 years of age who received 10 micrograms/0.1mL or more of the adult formulation	Consider this a valid dose Give the second dose with the recommended age-appropriate dosage, product and interval (NACI recommends an interval of at least 8 weeks) once the child reaches the age that they can receive an authorized mRNA vaccine Inform the parent/guardian and child of the potential for local and systemic adverse events^{Footnote 1}
Age	If a 10-mcg dose of Pfizer-BioNTech Comirnaty is used for a person 12 years of age and older	If a child/adolescent 12 to 17 years of age inadvertently received a 10-microgram dose, consider the dose(s) valid and do not repeat (even if both doses were 10 mcg). If this was their first dose, the second should be 30 microgram dose 8 weeks later. For a client 18 years of age and older, refer to the Quick reference guide on use of COVID-19 vaccines for youth and adults (12 years and older)
COVID-19 vaccine administered within 14 days before or after a non-COVID-19 vaccine	COVID-19 vaccine dose administered on the same day, or up to 14 days before or after another vaccine (a non-COVID-19 vaccine)	Both the COVID-19 and the other vaccine are valid
Intervals	2 doses of a COVID-19 vaccine given too close together in time (including on the same day)	Inform the parent/guardian and child of the potential for local and systemic adverse events If the second dose was administered 19 or more days after the first for Pfizer-BioNTech Comirnaty, consider both doses valid and the series complete If the second dose was administered less than 19 days after the first for Pfizer-BioNTech Comirnaty, consider the second dose invalid. for invalid doses, repeat with at least an 8-week interval from the date of the invalid dose if a significant local or systemic reaction from the invalid dose occurs, consult with a physician or nurse with expertise in immunization before repeating When repeating the dose, inform the parent/guardian and child of the potential for local and systemic adverse events
Intervals	Second dose administered later than the suggested optimal interval of at least 8 weeks	There is no interval that is too long and all doses would be considered valid No further doses are required
Dosage (refer to the following Diluent section for specific information on Pfizer-BioNTech Comirnaty and the diluent)	Higher-than-authorized dose volume administered	Consider this dose valid If that was the first dose, and the child needs a second dose, use the age-appropriate dose given at least 8 weeks later Inform the parent/guardian and child of the potential for local and systemic adverse events^{Footnote 1}
	Lower-than-authorized dose volume administered (for example, leaked out, equipment failure, client pulled away)	If less than a full dose may have been administered, consider it invalid (the following note gives the exception) If the error is discovered on the same clinic day, administer a full repeat dose immediately in another appropriate site If error is discovered after the clinic day: if the invalid dose was a first dose, administer a full repeat dose when the error is discovered If the invalid dose was not the first dose, wait 8 weeks to offer the repeat dose (unless the amount administered is likely to be very small, in which case repeat immediately) Inform the parent/guardian and child of the potential for local and systemic adverse events^{Footnote 1} Note: If a child/youth 12 to 17 years of age inadvertently received a 10-microgram dose, consider the dose(s) valid and do not repeat (even if both doses were 10 mcg). If this was their first dose, the second should be a 30-microgram dose 8 weeks later.
	More or less than the authorized number of doses obtained from the vial	As long as the correct volume was drawn up per dose (and the correct amount of diluent was used), the doses are valid
Storage and handling	Dose administered after improper storage and handling (for example, temperature excursion)	Contact the manufacturer for guidance, as well as your local public health authority for advice If the manufacturer provides information suggesting the dose should be considered invalid and if that seems appropriate based on clinical judgment, a repeat dose may be given. Consider delaying the repeat dose until 8 weeks from the invalid dose Inform the parent/guardian and child of the potential for local and systemic adverse events^{Footnote 1}
Storage and handling	Dose administered past the expiration/beyond use date	Contact the manufacturer for guidance, as well as your local public health authority for advice If the manufacturer provides information suggesting the dose should be considered invalid and if that seems appropriate based on clinical judgment, a repeat dose may be given. Consider delaying the repeat dose until 8 weeks from the invalid dose Inform the parent/guardian and child of the potential for local and systemic adverse events^{Footnote 1}
Diluent (Pfizer-BioNTech Comirnaty only)	Incorrect diluent type	Contact the manufacturer for guidance, as well as your local public health authority for advice If the manufacturer provides information suggesting that the dose be considered invalid and if that seems appropriate based on clinical judgment, a repeat dose may be given. Consider delaying the repeat dose until 8 weeks from the invalid dose Inform the parent/guardian and child of the potential for local and systemic adverse events^{Footnote 1}
	ONLY diluent administered	Inform the parent/guardian and child that no vaccine was administered Administer the authorized (appropriately diluted) dose as soon as possible in another appropriate site
	Too much diluent administered (more than 1.3 ml of diluent was added to the vial, based on 0.2 ml dose administered)	If more than 1.3 ml of diluent was added to the vial, consider this an invalid dose. If the error is discovered on the same clinic day, administer a full repeat dose immediately in another appropriate site If error is discovered after the clinic day: if the invalid dose was a first dose, administer a full repeat dose when the error is discovered if the invalid dose was not the first dose, wait 8 weeks to offer the repeat dose Inform the parent/guardian and child of the potential for local and systemic adverse events^{Footnote 1}
	No diluent or less than the recommended diluent, resulting in higher than the authorized dose (based on 0.2-ml dose administered)	Consider this dose valid Inform the parent/guardian and child of the potential for local and systemic adverse events^{Footnote 1}
Footnotes Footnote 1 This footnote applies to children who have had an invalid dose, which has been repeated with a valid dose or a dose that was too high: If the child requires a second dose to complete the initial series, the suggested optimal interval to receive the second dose is at least 8 weeks from the valid dose. Advise the parent/guardian and child about the potential for local and systemic adverse events following the second dose. If a child who requires a second dose has developed a significant local or systemic reaction from an earlier dose, base the decision to administer the second dose on a case-by-case basis in consultation with an allergist/immunologist or other appropriate physician. Return to footnote 1 referrer

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Quick reference guide on use of COVID-19 vaccine for children 5 to 11 years of age: Managing vaccine administration errors or deviations

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What to do after an error or deviation is detected

Type of administration errors or deviations and recommended actions

Footnotes

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