Table of updates: Recommendations on the use of COVID-19 vaccines

This table summarizes the updated information provided in each version of the Recommendations on the use of COVID-19 vaccines document page since the publication of the first version on December 12, 2020.

For previous versions of the COVID-19 vaccine statement, visit the archives.

Recommendations on the use of COVID-19 vaccines

Published September 28, 2021
Section Update Date
Vaccines On September 16, 2021, Health Canada approved the Pfizer-BioNTech Comirnaty COVID-19 vaccine and Moderna Spikevax COVID-19 vaccine for use in Canada under the Food and Drug Regulations. The label for the AstraZeneca COVID-19 vaccine was also modified to include the new name Vaxzevria. 2021-09-28
Vaccines Table 2 and "Storage Requirements" have been updated to reflect the revised product monograph for Pfizer-BioNTech Comirnaty. The storage temperature range was changed from -80°C to -60°C, to -90°C to -60°C. 2021-09-28
Vaccines All sub-sections under the section "Vaccines" have been updated to include evidence or information from the revised product monograph related to the authorization of Moderna Spikevax use in 12-17 year olds. This includes:
  • Table 2. COVID-19 vaccines authorized for use in Canada
  • Efficacy and effectiveness
  • Vaccine safety and adverse events following immunization
2021-09-28
Vaccines The sections "Booster doses and re-immunization" and "Special populations: Individuals who are immunocompromised due to disease or treatment" have been updated to include information on an additional dose of COVID-19 vaccine in immunocompromised individuals. 2021-09-28
Vaccines: Concomitant administration with other vaccines There is a new recommendation that COVID-19 vaccines may be given at the same as, or any time before or after other vaccines, including live, non-live, adjuvanted or unadjuvanted vaccines. 2021-09-28
Vaccines The section on "Special populations: Individuals who are pregnant or breastfeeding" has been updated with additional information from Developmental and Reproductive Toxicity (DART) animal studies for AstraZeneca Vaxzevria COVID-19 vaccine. 2021-09-28
Vaccines The sections "Vaccine safety and adverse events following immunization (AEFI)" and "Contraindications and precautions" have been updated to include content on Guillain-Barre Syndrome. 2021-09-28
Recommendations NACI's recommendation on the use of COVID-19 vaccines in pediatric populations has been updated to acknowledge the NACI recommendation on the use of the Moderna Spikevax in addition to the Pfizer-BioNTech Comirnaty in adolescents 12 to 17 years of age issued on August 27, 2021 in a separate document. 2021-09-28
Recommendations NACI's recommendation on the use of COVID-19 vaccines in immunocompromised persons has been updated to acknowledge the NACI recommendation for an additional dose of COVID-19 vaccine in immunocompromised individuals following a 1- or 2- dose primary series issued on September 10, 2021 in a separate document. 2021-09-28
Appendix B Appendix B "Clinical trial evidence summary for Moderna Spikevax COVID-19 vaccine" has been updated to include evidence or information from the revised product monograph related to the authorization of Moderna Spikevax use in 12-17 year olds. 2021-09-28
Appendix E

Appendix E "Frequency of solicited adverse events following immunization for COVID-19 vaccines in clinical trials" has been updated to include evidence or information from the revised product monograph related to the authorization of Moderna Spikevax use in 12-17 year olds.

Appendix E has also been updated with reactogenicity information from the revised product monograph for Pfizer-BioNTech Comirnaty.

2021-09-28

Recommendations on the use of COVID-19 vaccines (version now archived)

View the archived version.

Published July 22, 2021

Section Update Date
Vaccines: Special populations Updated summary of evidence on risk of re-infection and vaccination in individuals with prior SARS-CoV-2 infection. 2021-07-22
Recommendations Summary of evidence and rationale for NACI recommendation (#4) on vaccination of individuals with prior SARS-CoV-2 has been updated to reflect latest evidence. 2021-07-22

Recommendations on the use of COVID-19 vaccines (version now archived)

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Published July 2, 2021

Section Update Date
Vaccines: Uncommon, rare, and very rare adverse events The section on myocarditis and pericarditis following vaccination with mRNA vaccines has been updated, and a section on Capillary leak syndrome (CLS) following vaccination with AstraZeneca COVID-19 vaccine has been added. 2021-07-02
Vaccines: Precautions A section on myocarditis and/or pericarditis following mRNA COVID-19 vaccination has been added. As a precautionary measure, the second dose in the mRNA COVID-19 vaccination series should be deferred in individuals who experience myocarditis or pericarditis following the first dose of an mRNA COVID-19 vaccine until more information is available. NACI will continue to monitor the evidence and update recommendations as needed. 2021-07-02
Contraindications A history of capillary leak syndrome has been added as a contraindication to vaccination with AstraZeneca/COVISHIELD COVID-19 vaccine 2021-07-02
Recommendations To assist with information consent, the rationale for NACI recommendation (#1) on the use of mRNA vaccines now includes information on very rare reports of myocarditis and pericarditis following mRNA vaccination, noting that cases have reported most frequently in adolescents and younger adults under 30 years of age, more frequently in males compared to females, and more frequently after the second dose. 2021-07-02
Recommendations NACI recommendation (#11) on the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents has been updated to include guidance on informed consent in reference to very rare reports of myocarditis and pericarditis following mRNA vaccination, as noted above. 2021-07-02
Table 5. Vaccination considerations for types of COVID-19 vaccines authorized for use in Canada Updated content to reflect changes to guidance as noted above. 2021-07-02

Recommendations on the use of COVID-19 vaccines (version now archived)

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Published June 17, 2021

Section Update Date
Vaccines Table 2 and "Storage Requirements" have been updated to reflect the revised product monograph for Moderna COVID-19 vaccine allowing storage of unpunctured vials between +8°C to +25°C for up to 24 hours and indicating that punctured vials should be discarded after 24 hours. 2021-06-17
Vaccines The recommendation on interchangeability of vaccines and the accompanying section has been revised based on emerging evidence. 2021-06-17
Vaccines The recommendation on simultaneous administration of COVID-19 vaccines with other vaccines has been updated. 2021-06-17
Vaccines A section on "Myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine" has been added to summarize information on this safety signal that is being investigated. Rates of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) have been updated as new evidence has emerged. 2021-06-17

Recommendations
NACI recommendation (#2) on the use of viral vector vaccines has changed due to increasing mRNA vaccine supply and increasing reports of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) following vaccination with viral vector COVID-19 vaccines. The risk assessment tool to assist with the decision for vaccination with viral vector vaccines has been removed to align with this change. The risk assessment tool can be found in the archived versions of this statement. 2021-06-17
Recommendations The NACI recommendation (previously #4) on the continuation of public health measures regardless of COVID-19 vaccination status has been removed, as easing of restrictions and adherence to certain public health requirements may vary by jurisdiction and authority. Please refer to provincial/territorial and local public health authorities for guidance on the continuation of public health measures. 2021-06-17
Recommendations NACI's recommendations for COVID-19 vaccination in those who are immunosuppressed, have autoimmune conditions, are pregnant or breastfeeding have been updated to reflect the changes to the recommendation on the use of viral vector vaccines. 2021-06-17

Recommendations on the use of COVID-19 vaccines (version now archived)

View the archived version.

Published May 28, 2021

Section Update Date
Epidemiology Table 1 has been updated with the results of an updated rapid review of risk factors for severe outcomes from COVID-19. 2021-05-28
Vaccines Table 2 and “Storage Requirements” have been updated to reflect the revised product monograph for Pfizer-BioNTech COVID-19 vaccine allowing thawed undiluted vials to be stored in the refrigerator (2°C to 8°C [35°F to 46°F]) for up to 1 month. 2021-05-28
Vaccines

All sub-sections under the section “Vaccines” have been updated to include evidence or information from the revised product monograph related to the Pfizer-BioNTech COVID-19 vaccine in 12-15 year olds. This includes:

  • Table 2. COVID-19 vaccines authorized for use in Canada
  • Efficacy and Effectiveness
  • Vaccine safety and adverse events following immunization
2021-05-28
Vaccines A section summarizing accumulating evidence on COVID-19 vaccination in populations who were excluded from clinical trials (or included in small numbers) has been added. These populations include: those previously infected with SARS-CoV-2; and those who are immunosuppressed, have an autoimmune condition, or are pregnant or breastfeeding. 2021-05-28
Recommendations NACI’s recommendation on the use of COVID-19 vaccines in pediatric populations has been updated to acknowledge the NACI recommendation on the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents 12 to 18 years of age issued on May 18, 2021 2021-05-28
Recommendations NACI’s recommendation on the extended interval between doses of a two-dose COVID-19 vaccine series has been updated in the context of increasing vaccine supplies. 2021-05-28
Recommendations NACI’s recommendations for COVID-19 vaccination in those who are immunosuppressed, have autoimmune conditions, are pregnant or breastfeeding have been updated based on emerging evidence. 2021-05-28
Management options for
COVID-19 vaccines authorized and available for use in Canada
Table 5 has been updated with additional data for the Pfizer-BioNTech COVID-19 vaccine. 2021-05-28
Appendix A Evidence on the efficacy, immunogenicity and safety of the Pfizer-BioNTech COVID-19 vaccine has been updated to reflect the May 5th Health Canada authorization for use in adolescents 12 to 15 years of age. 2021-05-28

Recommendations on the use of COVID-19 vaccines (version now archived)

Published May 21, 2021

Section Update Date
Vaccines

Information on Vaccine Induced Immune Thrombotic Thrombocytopenia (VITT) has been updated in the subsection:

  • Uncommon, rare, and very rare adverse events
2021-05-21
Interchangeability NACI clarified its recommendation to complete the vaccine series with the same COVID-19 vaccine product when possible. This section was updated to provide direction for when this is not possible, noting that recommendations on which vaccine product to complete a vaccine series in those who have received one dose of the AstraZeneca COVID-19 vaccine will be forthcoming after further evidence on mixed vaccine schedules is available. 2021-05-21
Recommendations Information on Vaccine Induced Immune Thrombotic Thrombocytopenia (VITT) has been updated in the Risk Assessment Tool, the Summary of Evidence for Recommendation #2, and the Management Options table. 2021-05-21
Appendix F Appendix F: Benefit-risk assessment for the use of viral vector COVID-19 vaccines in a public health context, has been removed from the current version of the statement as it is no longer up-to-date. This Appendix can be found in the archived statement dated 2021-05-03. Archived versions of statements can be accessed via the "Previous versions" drop-down section of the COVID-19 publications list. 2021-05-21
Appendix G This appendix has been renamed Appendix F (Pregnancy, Breastfeeding, and Covid-19 Vaccine Registries). 2021-05-21

Recommendations on the use of COVID-19 vaccines (addition of Janssen COVID-19 vaccine) (version now archived)

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Published May 3, 2021

Section Update Date
Vaccines

All sub-sections under the section "Vaccines" have been updated to include evidence or information from the product monograph related to the Janssen COVID-19 vaccine. This includes:

  • Table 1. COVID-19 vaccines authorized for use in Canada
  • Efficacy and Effectiveness
  • Immunogenicity
  • Vaccine administration
  • Storage requirements
  • Vaccine safety and adverse events following immunization
2021-05-03
Vaccines A section on immunogenicity in individuals previously infected with SARS-CoV-2 has been included. 2021-05-03
Vaccines A section on adverse events following the second dose of COVID-19 vaccine in individuals previously infected with SARS-CoV-2 has been included. 2021-05-03
Recommendations NACI's overarching recommendation on the use of COVID-19 vaccines has been updated to include guidance on the use of the Janssen COVID-19 vaccine. The summary of evidence and rationale for this recommendation has been updated. 2021-05-03
Recommendations NACI's preferential recommendation for the use of mRNA vaccines in pregnancy has been highlighted given the complexities of the clinical management of Vaccine Induced Immune Thrombotic Thrombocytopenia (VITT) in pregnancy should it occur after vaccination with a viral vector vaccine. In addition, preliminary data on mRNA vaccines administered in pregnancy is now available, with no safety signals detected. The summary of evidence and rationale for the pregnancy and breastfeeding recommendations have been updated with additional information from Developmental and Reproductive Toxicity (DART) animal studies for Janssen COVID-19 vaccine. The evidence summary has also been updated to reflect current research on COVID-19 vaccination during pregnancy and breastfeeding. 2021-05-03
Management options for COVID-19 vaccines authorized and available for use in Canada Table 5 has been updated with data for Janssen COVID-19 vaccine. 2021-05-03
Appendix D Evidence on the efficacy, immunogenicity and safety of the Janssen COVID-19 vaccine has been added in a new appendix. 2021-05-03
Appendix E Tables capturing the frequency of solicited adverse events following immunization in clinical trials with mRNA and viral vector COVID-19 vaccines have been updated. 2021-05-03
Appendix F The benefit risk assessment for the use of Janssen COVID-19 vaccine in a public health context has been added. 2021-05-03
Appendix G Information on pregnancy and COVID-19 vaccine registries has been added in a new appendix. 2021-05-03

Recommendations on the use of COVID-19 vaccines (version now archived)

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Published April 23, 2021

Section Update Date
Introduction The goal of Canada's COVID-19 immunization response has been included. 2021-04-23
Epidemiology A section on variants of concern has been inserted. 2021-04-23
Epidemiology The section on risk factors has been updated with evidence on factors associated with increased risk of severe outcomes from COVID-19 and increased risk of exposure to COVID-19. 2021-04-23
Efficacy and effectiveness Emerging evidence on vaccine effectiveness for authorized and available COVID-19 vaccines against severe outcomes and asymptomatic infection has been included. 2021-04-23
Vaccine safety and adverse events following immunization Information on the recently detected Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) following vaccination with AstraZeneca COVID-19 vaccine has been included. 2021-04-23
Recommendations NACI's recommendation on the use of COVID-19 vaccines has been updated in light of the safety signal of VITT following vaccination with the AstraZeneca vaccine. 2021-04-23
Recommendations The summaries of evidence and rationale for the recommendations on populations who were excluded from or included in small numbers in clinical trials of COVID-19 vaccines (immunosuppressed, people with autoimmune conditions, pregnant people, children/adolescents) have been updated to include evidence from a rapid review of risk factors for severe outcomes of COVID-19. 2021-04-23
Recommendations The summary of evidence and rationale for the pregnancy and breastfeeding recommendations have been updated with additional information from Developmental and Reproductive Toxicity (DART) animal studies for Pfizer-BioNTech COVID-19 vaccine. 2021-04-23
Management options for COVID-19 vaccines authorized and available for use in Canada Table 5 has been updated with evidence on protection against variants of concern (VOC), effectiveness against severe outcomes and asymptomatic infection, and recent survey results on vaccine acceptability in Canada. The table has also been updated to include information on VITT following vaccination with AstraZeneca COVID-19 vaccine. 2021-04-23
Appendix B The vaccine safety and adverse events following immunization section of the Evidence Summary for Moderna COVID-19 vaccine has been updated with information on delayed injection site reactions and facial swelling. 2021-04-23
Appendix C The vaccine safety and adverse events following immunization section has been updated with information on the recently detected VITT following vaccination with AstraZeneca COVID-19 vaccine. 2021-04-23
Appendix D Tables capturing the frequency of solicited adverse events following immunization in clinical trials with mRNA and AstraZeneca COVID-19 vaccines have been updated. 2021-04-23
Appendix E A benefit-risk assessment for the use of AstraZeneca COVID-19 vaccine in a public health context was added. 2021-04-23

Recommendations on the use of COVID-19 vaccines (version now archived)

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Published March 16, 2021

Section Update Date

Introduction

Health Canada authorized two manufacturers to produce the vaccine developed by AstraZeneca and Oxford University: AstraZeneca and Serum Institute of India (SII). NACI has not specifically reviewed evidence for the SII vaccine, but Health Canada has deemed SII and AstraZeneca vaccines to be comparable.

2021-03-16

Vaccines

Table 1. COVID-19 vaccines authorized for use in Canada has been updated to reflect the change in the Pfizer BioNTech COVID-19 product monograph regarding storage requirements.

2021-03-16

Schedule

Table 2. Recommended immunization schedule, by COVID-19 vaccine has been updated to reflect NACI's current recommendation for extending the interval for the second dose of COVID-19 vaccines up to four months after the first. The rationale for the intervals included in this table has been included.

2021-03-16

Storage Requirements

Storage requirements for the Pfizer BioNTech COVID-19 vaccine have been updated to reflect changes in the product monograph which allow vials to also be stored at -25°C to -15°C for up to 2 weeks.

2021-03-16

Recommendations

The recommendation on the use of the AstraZeneca COVID-19 vaccine has been updated to include use in those 65 years of age and older. This update is based on results of observational studies of vaccine effectiveness from the United Kingdom released since NACI's previous recommendations for the use of this vaccine in those 18 to 64 years of age. The rationale for this updated recommendation for the use of AstraZeneca COVID-19 vaccine in those ≥18 years of age has been added.

2021-03-16

Recommendations

The recent recommendation made by NACI on extending the interval for the second dose of COVID-19 vaccines up to four months after the first, summarized in a separate document, is now included. The rationale for this recommendation has been summarized.

2021-03-16

Management options for COVID-19 vaccines authorized for use in Canada

Table 4 has been updated with observational data for AstraZeneca COVID-19 vaccine effectiveness in individuals > 65 years of age.

2021-03-16

Research Priorities

Three additional research priorities have been added under the Efficacy, Effectiveness, Immunogenicity and Safety section.

2021-03-16

Appendix C

A summary and review of evidence on the effectiveness of the AstraZeneca COVID-19 vaccine based on observational studies published as pre-prints has been added to the appendix on the Evidence Summary for AstraZeneca vaccine.

2021-03-16

Recommendations on the use of COVID-19 vaccines (addition of AstraZeneca COVID-19 vaccine) (version now archived)

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Published March 1, 2021

Section Update Date
Vaccines

All sub-sections under Vaccines have been updated to include evidence or information from the product monograph related to the AstraZeneca COVID-19 vaccine. This includes:

  • Table 1. COVID-19 vaccines authorized for use in Canada
  • Dose, Route of administration, and Schedule
  • Efficacy and Immunogenicity
  • Storage requirements
  • Vaccine safety and adverse events following immunization
2021-03-01
Vaccines Table 1. COVID-19 vaccines authorized for use in Canada has been updated to reflect the change in the Pfizer BioNTech COVID-19 product monograph stating one multi-dose vial contains 6 doses. 2021-03-01
Contraindications and Precautions Tromethamine as an ingredient in the Moderna COVID-19 vaccine that has been associated with allergic reactions in other products has been added to Table 3. Clarification on the management of allergies and allergic reactions has been added, in consultation with NACI's Vaccine Safety Working Group. 2021-03-01
Contraindications and Precautions Potential allergens for AstraZeneca COVID-19 vaccine have been added to Table 3. 2021-03-01
Drug Interactions Guidance on the use of tuberculin skin tests and interferon gamma release assays before or after administration of COVID-19 vaccine has been added. 2021-03-01
Recommendations Recommendations on COVID-19 vaccine now include use of the AstraZeneca COVID-19 vaccine, and the rationales have been updated with evidence from AstraZeneca COVID-19 vaccine clinical trials. 2021-03-01
Recommendations A management options table for the use of different types of COVID-19 vaccines authorized for use in Canada has been added. 2021-03-01
Appendix C Evidence on the efficacy, immunogenicity, and safety of the AstraZeneca COVID-19 vaccine has been added in a new appendix. 2021-03-01
Appendix D Frequency of Solicited Adverse Events Following Immunization for COVID-19 vaccines has been updated to include information on the AstraZeneca COVID-19 vaccine. 2021-03-01

Recommendations on the use of COVID-19 vaccines (version now archived)

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Published January 12, 2021

Section Update Date
Dose, route of administration, and schedule Section on "Delay in receipt of dose 2 in a COVID-19 vaccine series" has been updated to include calculated vaccine efficacy estimates of COVID-19 vaccines after the first dose. 2021-01-12
Recommendations Options for the administration of a complete COVID-19 vaccines series to maximize population health benefits in the context of vaccine delivery, epidemiological, and healthcare system capacity considerations have been added. 2021-01-12
Recommendations Recommendations for immunosuppressed persons, persons with an autoimmune condition, and pregnancy and breastfeeding have been revised for clarity. 2021-01-12
Management Options A section of management options for COVID-19 immunization program roll-out in the context of limited vaccine supply has been added. This section summarizes available evidence and considerations with decision points to guide jurisdictions in the roll-out of an effective, efficient, and equitable COVID-19 immunization program. 2021-01-12
Appendix A Calculated vaccine efficacy estimates of the Pfizer-BioNTech COVID-19 vaccine after the first dose have been added. 2021-01-12
Appendix B Calculated vaccine efficacy estimates of the Moderna COVID-19 vaccine after the first dose have been added. 2021-01-12

Recommendations on the use of COVID-19 vaccines (addition of Moderna COVID-19 vaccine) (version now archived)

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Published December 23, 2020

Section Update Date
Vaccine(s)

All sub-sections under Vaccines have been updated to include evidence or information from the product monograph related to the Moderna COVID-19 vaccine. This includes:

  • Table 1. COVID-19 vaccine(s) authorized for use in Canada
  • Dose, Route of administration, and Schedule
  • Efficacy and Immunogenicity
  • Storage requirements
  • Vaccine safety and adverse events following immunization
2020-12-23
Dose, route of administration, and schedule Additional clarifying information on the schedule for a complete mRNA COVID-19 vaccine series has been added. 2020-12-23
Interchangeability Additional information on the interchangeability of mRNA vaccines and guidance in case of limited supply or unavailability of a particular product has been incorporated under the NACI recommendation on interchangeability. 2020-12-23
Recommendations Recommendations on COVID-19 vaccine now include use of the Moderna COVID-19 vaccine, and the rationales have been updated with evidence from Moderna COVID-19 vaccine clinical trials 2020-12-23
Recommendations The recommendations for immunosuppressed individuals and those with autoimmune conditions have been split into two separate recommendations and further rationale for the recommendations has been provided. 2020-12-23
Recommendations Additional information has been added to the rationale for the recommendation on pregnancy and breastfeeding and now recommends that it would be prudent to delay pregnancy by at least 28 days after the completion of a two-dose series of mRNA COVID-19 vaccines. 2020-12-23
Appendix B Evidence on the efficacy, immunogenicity, and safety of the Moderna COVID-19 vaccine has been added in a new appendix 2020-12-23
Appendix C Application of the EEFA Framework: Ethical analysis of the options for the delivery of a second dose of COVID-19 vaccine in the context of a limited vaccine supply has been added in a new appendix 2020-12-23
Appendix D Frequency of Solicited Adverse Events Following Immunization for COVID-19 vaccine has been added in a new appendix 2020-12-23

Recommendations on the use of COVID-19 vaccine(s) (version now archived)

The first version of the evergreen document was published outlining the recommendations for use of the Pfizer BioNTech COVID-19 vaccine.

Published December 12, 2020

Section Update Date
Contraindications and Precautions

Reinforced existing recommendation that the authorized COVID-19 vaccines are contraindicated in individuals with a history of anaphylaxis after previous administration of the vaccine and included a new table with vaccine components that are potential allergens known to cause type 1 hypersensitivity reactions

  • New Table 3. Potential allergens known to cause type 1 hypersensitivity reactions
2020-12-12
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