COVID-19 vaccine guide for youth and adults (12 years and over): Managing COVID-19 vaccine administration errors or deviations

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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:

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 see 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 (that is, site other than the deltoid muscle [preferred site] or anterolateral thigh [alternate site])
  • Consider this a valid dose
  • Inform the client of the error or deviation and the potential for local and systemic adverse events and that the dose is acceptable
  • Incorrect route (for example, subcutaneous)
  • Consider this a valid dose
  • Inform the client of the error or deviation and potential for local and systemic adverse events and that the dose is acceptable

Age

  • If a 10-mcg dose of Pfizer-BioNTech Comirnaty is used for a client 12 years of age and older

Please see recommendation for lower-than-authorized dose

  • Dose or product administered to a client who is younger than the minimum age authorized by Health Canada to receive the product
  • Inform the client of the potential for local and systemic adverse eventsTable 4 Footnote 1

Pfizer-BioNTech Comirnaty and Moderna Spikevax vaccines:

  • Consider this a valid dose
  • Give the subsequent dose with the recommended age-appropriate dosage, product and interval once the client reaches the age that they can receive an mRNA vaccine
  • NACI recommends:
    • an interval of at least 8 weeks between the first and second dose and
    • Pfizer-BioNTech Comirnaty is the preferred product for the primary series for those 12 to 29 years of age
    • Pfizer-BioNTech Comirnaty may be the preferred product for the booster dose for those 18 to 29 years of age

AstraZeneca Vaxzevria vaccine:

  • Consider this a valid dose
  • Preferentially give an mRNA vaccine for the second dose with the recommended age-appropriate dosage, mRNA product and interval once the client reaches the age that they can receive an authorized mRNA vaccine
  • NACI recommends:
    • an interval of at least 8 weeks between the first and second dose and
    • Pfizer-BioNTech Comirnaty is the preferred product for the primary series for those 12 to 29 years of age
    • Pfizer-BioNTech Comirnaty may be the preferred product for the booster dose for those 18 to 29 years of age

Janssen vaccine

  • Consider this a valid dose
  • When the client has reached the age that they are eligible to receive an mRNA vaccine, provide an age-appropriate mRNA dose 6 months after the Janssen dose
  • NACI recommends the Pfizer-BioNTech Comirnaty vaccine for those 12 to 29 years of age

Intervals

  • First 2 doses of a COVID-19 vaccine given too close together in time (including on the same day)
  • Inform the client 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 or 21 or more days after the first for Moderna Spikevax or AstraZeneca Vaxzevria, 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 or less than 21 days after the first for Moderna Spikevax or AstraZeneca Vaxzevria, 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 client of the potential for local and systemic adverse events
  • Second dose administered later than the longest NACI-recommended optimal of 8 weeks
  • There is no interval that is too long and all doses would be considered valid
  • Third dose in the primary series administered earlier than the 28-day minimum interval for moderately to severely immunocompromised individuals
  • Consider the dose valid
  • Offer a booster dose when recommended
  • Booster dose given at less than a 6-month interval from the last dose in the primary series
  • As long as at least 8 weeks has passed since the last dose in the primary series, consider the booster dose valid
  • If less than 8 weeks has passed between the last dose in the primary series and the booster dose, consider the booster dose invalid and repeat the booster dose at least 6 months from the invalid dose

Mixed COVID-19 vaccines for first, second or additional/booster doses

  • A different COVID-19 vaccine used for the first, second or additional/booster dosesTable 4 Footnote 2
  • Consider all doses valid regardless of the vaccine type
  • Refer to footnote for those who received only non-Health Canada authorized vaccinesTable 4 Footnote 2

Dosage

(Refer to the following Diluent section or specific information on Pfizer-BioNTech Comirnaty and the diluent)

  • Higher-than-authorized dose volume administered
  • Consider this dose valid
  • Inform the client of the potential for local and systemic adverse eventsTable 4 Footnote 1
  • Lower-than-authorized dose volume administered (for example, leaked out, equipment failure, client pulled away or pediatric dose administered to an adult 18 years or older)
  • If less than a full dose may have been administered, consider it invalid (refer to the following notes for exceptions)
  • If the error is discovered on the same clinic day, administer a full repeat dose immediately in another appropriate site
  • If the 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 client of the potential for local and systemic adverse eventsTable 4 Footnote 1
  • Note:
    • if Moderna is being used as an additional dose for a moderately to severely immunocompromised individual (for whom the full 100-microgram dose is recommended) and only 50 micrograms was inadvertently administered, consider the dose valid and do not repeat
    • if Moderna is being used as a booster dose and the full 100-microgram dose may be preferred according to NACI and only 50 micrograms was inadvertently administered, consider the dose valid and do not repeat
    • if an 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 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, if applicable), the doses are valid

Storage and handling

  • Dose administered after improper storage and handling (for example, temperature excursion)
  • Contact the manufacturer for guidance. Your local public health authority can also be consulted for advice.
  • If the manufacturer provides information suggesting the dose should be considered invalid and if that seems appropriate based on clinical judgment, a repeated dose may be given. Consider delaying the repeat dose until 8 weeks from the invalid dose.
  • Inform the client of the potential for local and systemic adverse eventsTable 4 Footnote 1
  • Dose administered past the expiration/beyond use date
  • Contact the manufacturer for guidance. Your local public health authority can also be consulted 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 client of the potential for local and systemic adverse eventsTable 4 Footnote 1

Diluent (Pfizer-BioNTech Comirnaty only)

  • Incorrect diluent type
  • Contact the manufacturer for guidance. Your local public health authority can also be consulted 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 client of the potential for local and systemic adverse eventsTable 4 Footnote 1
  • ONLY diluent administered (that is, 0.9% sodium chloride)
  • Inform the client 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 2 ml of diluent added to the vial) (based on 0.3 ml dose administered)
  • If more than 2 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 the 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 client of the potential for local and systemic adverse eventsTable 4 Footnote 1
  • No diluent or less than the recommended diluent, resulting in higher than the authorized dose (based on 0.3 ml dose administered)
  • Consider this dose valid
  • Inform the client of the potential for local and systemic adverse eventsTable 4 Footnote 1
Table 4 Footnote 1

This footnote applies to people who have had an invalid dose that has been repeated with a valid dose or a dose that was too high.

If the client requires a subsequent dose in the initial series (for example, second dose, or for those who are moderate to severely immunocompromised, the third dose), the suggested optimal interval is at least 8 weeks from the last valid dose. Advise the client about the potential for local and systemic adverse events following the subsequent dose.

If the client requires a booster dose, wait 6 months from the last valid dose in the initial series.

If the client has developed a significant local or systemic reaction from an earlier dose, base your decision to administer future doses on a case-by-case basis in consultation with an allergist/immunologist or other appropriate physician.

Table 4 Return to footnote 1 referrer

Table 4 Footnote 2

Note: If no Health Canada-authorized vaccine has been received and less than 3 doses of COVID-19 vaccines have been received, a dose of an mRNA vaccine is recommended for those planning to live, work or study in Canada. Refer to COVID-19: Recommendations for those vaccinated with vaccines not authorized by Health Canada for those staying in Canada to live, work or study.

Table 4 Return to footnote 2 referrer

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