Summary of updates in the Canadian Immunization Guide of June 21 2022: Updated guidance on COVID-19 vaccines in Canada
Published: June 21, 2022
On June 21, 2022, the Public Health Agency of Canada (PHAC) released updated guidance on the use of COVID-19 vaccines in the COVID-19 vaccine chapter of the Canadian Immunization Guide (CIG). This guidance is based on current evidence and the National Advisory Committee on Immunization’s (NACI’s) expert opinion.
What you need to know
The following updates were made to the COVID-19 vaccine chapter:
- Concurrent administration of COVID-19 vaccines and other vaccines for children 5 to 11 years of age.
- Guidance on the use of Evusheld (AstraZeneca) in the context of COVID-19 vaccination.
1. Concurrent administration of COVID-19 vaccines and other vaccines for children 5 to 11 years of age
NACI was asked to revisit guidance on concurrent administration of COVID-19 vaccines and other vaccines for children 5 to 11 years of age. After reviewing the published literature and Canadian surveillance data, the NACI Vaccine Safety Work Group (VSWG) recommended to extend existing concurrent administration guidance for individuals aged 12 years and older to individuals 5 years of age and older. This decision was based on: vaccine principles, better knowledge of the safety of COVID-19 mRNA vaccines in children 5-11 years of age, and the need to improve uptake of routine vaccines which has been negatively impacted by the COVID-19 pandemic. The studies identified included a limited number of adult participants and mostly assessed concurrent administration of COVID-19 vaccines with influenza vaccines. No safety signals have been identified to date. There is a need for further studies on the impact of concurrent vaccine administration on vaccine safety, immunogenicity and efficacy by vaccine product, dose, and population. The following guidance was approved by NACI during a virtual meeting on May 10, 2022:
“For individuals 5 years of age and older, COVID-19 vaccines may be given concurrently with (i.e., same day), or at any time before or after, non-COVID-19 vaccines (including live and non-live vaccines).
If more than one type of vaccine is administered at a single visit, they should be administered at different injection sites using separate injection equipment.
Informed consent should include a discussion of the benefits and risks given the limited data available on administration of COVID-19 vaccines at the same time as, or shortly before or after, other vaccines.
There are currently limited data available on whether the reactogenicity of COVID-19 vaccines is increased with concurrent administration of other vaccines. No specific safety concerns have been identified to date. Studies to assess the safety and immunogenicity of concurrent administration of COVID-19 vaccines with other vaccines are ongoing.”
Provided is the list of selected references that informed this guidance:
- Chilimuri S, Mantri N, Shrestha E, et al. BNT162b2 mRNA Vaccine Interference with Co-Administration of Tdap Vaccine. The American journal of case reports. 2021 Jul 25. https://amjcaserep.com/abstract/full/idArt/933003
- Izikson R, Brune D, Bolduc JS, et al. Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged ≥65 years: a phase 2, randomised, open-label study. Lancet Respir Med. 2022 Apr. https://doi.org/10.1016/S2213-2600(21)00557-9
- Lazarus R, Baos S, Cappel-Porter H, et al. Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial. Lancet. 2021 Dec 18. https://doi.org/10.1016/S0140-6736(21)02329-1
- Toback S, Galiza E, Cosgrove C, et al. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Feb. https://doi.org/10.1016/S2213-2600(21)00409-4
- Wang, S, Chen, B, Duan, X et al. Safety and Immunogenicity of a SARS-CoV-2 Inactivated Vaccine Administered Simultaneously with an Inactivated Quadrivalent Influenza Vaccine: A Randomized, Open-Label, Controlled Study in Healthy Adults Aged 18 to 59 Years in China. SSRN Preprint. 2021 Aug 23. http://dx.doi.org/10.2139/ssrn.3909773
2. Guidance on the use of Evusheld (AstraZeneca) in the context of COVID-19 vaccination
Evusheld (AstraZeneca) is currently the only anti-SARS-CoV-2 monoclonal antibody authorized in Canada for prophylaxis against COVID-19. Implementation advice to inform decision-makers on the appropriate use of Evusheld (e.g., patient prioritization) is available from the Canadian Agency for Drugs and Technologies in Health (CADTH), l’Institut national d'excellence en santé et en services sociaux (INESSS), and Ontario Health.
NACI was asked to provide guidance on a recommended interval between the use of Evusheld and COVID-19 vaccination. The Canadian Immunization Guide, Part 1, Blood Products Working Group met to discuss this topic on May 2, 2022. They reviewed the limited literature available and sought information from the manufacturer on this issue. Very limited data were available for Evusheld, in particular there were no data examining the impact of Evusheld on COVID-19 vaccination. Available data were limited to neutralizing antibody responses and antibody concentrations over time, for which the clinical relevance is unknown. The working group was consulted to inform guidance on the use of Evusheld in the context of COVID-19 vaccination. The guidance below was approved by NACI at a virtual meeting on May 24, 2022:
“It is recommended that COVID-19 vaccines should not be given concurrently with anti-SARS-CoV-2 monoclonal antibodies.”
“Pre-exposure prophylaxis for COVID-19 with anti-SARS-CoV-2 monoclonal antibodies
Some clinicians may choose to immunize with both COVID-19 vaccine and Evusheld. Administration of Evusheld and COVID-19 vaccines should be assessed in consultation with clinical experts. Clinicians may consider the following factors when assessing the potential benefits or risks when recommending Evusheld to their patients: the degree of immunocompromise, the presence of additional risk factors for severe COVID-19, the likelihood of not responding to COVID-19 vaccine, the risk of exposure to COVID-19 due to occupational or residential circumstances, as well as local circulation of variants with the potential for resistance to Evusheld. Although Evusheld could reduce humoral immune responses to a COVID-19 vaccine, cellular immune responses may not be impacted by Evusheld. Cellular immune responses to a COVID-19 vaccine are important for immunocompromised populations and, to sustain cellular immune responses, vaccination should not be withheld from this group.”
“Administration of Evusheld following COVID-19 vaccines
To minimize interference, it is recommended that Evusheld should be administered at least 2 weeks following COVID-19 vaccination.
Administration of COVID-19 vaccines following Evusheld
There is no evidence on which to base a specific minimum interval for COVID-19 vaccination following Evusheld administration, though it should be noted that both Evusheld dosage (300mg vs. 600mg) and time since administration are expected to influence potential interactions or interference with COVID-19 vaccines. Timing should be assessed in consultation with clinical experts on a case-by-case basis.”
Evusheld provides a passive immunization option for immunocompromised individuals and should not be considered a substitute for a COVID-19 vaccine. NACI will be closely monitoring developments in this area in order to understand the value of prophylactic anti-SARS-CoV-2 monoclonal antibody compared to or in concert with additional vaccine booster doses for immunocompromised populations.
Provided is the list of selected references that informed this guidance:
- AstraZeneca Canada Inc. Product monograph – Evusheld™. April 14, 2022.
- Canadian Agency for Drugs and Technologies in Health (CADTH). Evusheld (Tixagevimab and Cilgavimab) for the Pre-exposure Prophylaxis of COVID-19 in Adults and Adolescents (≥ 12 Years of Age and Weighing at Least 40 kg). [Internet]. Ottawa, (ON). 2022 April 21. [cited 2022 May 2] Available from: https://www.cadth.ca/evusheld-tixagevimab-and-cilgavimab-pre-exposure-prophylaxis-covid-19-adults-and-adolescents-12
- Institut national d'excellence en santé et en services sociaux (INESSS) - Tixagévimab/ Cilgavimab (EvusheldMC) en prophylaxie préexposition. [Internet]. Quebec, (QC): Gouvernement du Québec. 2022 Apr 28. [cited 2022 May 2]. Available from: https://www.inesss.qc.ca/covid-19/traitements-specifiques-a-la-covid-19/tixagevimab-/-cilgavimab-evusheld-en-prophylaxie-preexposition.html
- Levin MJ, Ustianowski A, De Wit S, et al. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19 [published online ahead of print, 2022 Apr 20]. The New England journal of medicine. 2022 Apr 20. https://www.nejm.org/doi/full/10.1056/NEJMoa2116620
- Loo YM, McTamney PM, Arends RH, et al. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Science Translational Medicine. 2022 Jan 25. doi:10.1126/scitranslmed.abl8124
- Ontario Health. Information about Evusheld (Tixagevimab and Cilgavimab) Reference for health care providers who may be prescribing or administering Evusheld. [Internet]. Ontario (ON). 2022 May 9. [cited 2022 May 24] Available from: https://www.ontariohealth.ca/sites/ontariohealth/files/2022-05/Information%20for%20health%20care%20providers%20-%20Evusheld.pdf
For more information on NACI’s recommendations on the use of COVID-19 vaccines, please refer to the COVID-19 vaccine chapter in the Canadian Immunization Guide (CIG), as well as additional statements on the NACI web page.
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