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This includes ensuring that the benefits of vaccines outweigh their risks. Information on vaccines and treatments authorized for COVID-19 can be found on Canada's COVID-19 vaccines and treatments portal (https://covid-vaccine.canada.ca/).
- Overview
- Non-clinical data
- Clinical data
Placebo-controlled disease endpoint trial data are the gold standard for authorizing vaccines. However, for COVID-19 vaccines, it is difficult to conduct efficacy trials in some countries, as few candidates are willing and available to participate. Without established humoral and/or cellular immune parameters that correlate to clinical protection against disease, other approaches are needed to provide sufficient evidence for authorizing new COVID-19 vaccines.
The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a workshop on June 24, 2021, to consider the development of COVID-19 vaccines. The ICMRA focused on immunobridging, the design and use of controlled trials (placebo or other controls) and correlates of protection.
Access Consortium members agree that well-justified and appropriately designed immunobridging studies are an acceptable approach for authorizing COVID-19 vaccines.
The Consortium provides additional considerations for cross-platform immunobridging. These include extending previous points of consideration for variant-based vaccines that was limited to currently authorized COVID-19 vaccines.
Consensus positions from the ICMRA meeting relevant to this statement include:
The Access Consortium considers that the weight of evidence from studies with authorized COVID-19 vaccines is sufficient to support using neutralizing antibody titres as a primary endpoint in cross-platform immunobridging trials.
As well as common non-clinical requirements for new vaccines and adjuvants, non-clinical data should include:
•relevant animal challenge studies that support proof of concept for the candidate vaccine and demonstrate effectiveness against variants of concern (VOCs)
Along with a comparison of neutralizing antibody titres, clinical data should include:
•characterization of comparative immunogenicity profiles, including cell-mediated immunity
•characterization of comparative in vitro neutralization against VOCs
•safety database of at least 3,000 study participants vaccinated with the dosing regimen intended for authorization (this is in line with the pre-authorization safety data requirements for preventive vaccines for infectious diseases)
•commitment for safety and immunogenicity follow-up for at least 12 months of the subjects enrolled in safety/immunobridging trials, which would also record descriptive clinical efficacy data
•commitment for post-authorization effectiveness studies supported with a study protocol considering current WHO guidance
This document provides guidance to vaccine manufacturers seeking authorization for their vaccine that targets the SARS-CoV-2 virus. This guidance applies to applications under the interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19.
Nov 10, 2021 · Recommendations on the use of COVID-19 vaccines (2021-09-28) This evergreen document will be updated as COVID-19 vaccines are authorized and become available for use in Canada, and as evidence on these vaccines and COVID-19 evolves. This table summarizes the latest changes to this current version.
May 3, 2023 · Hover over or select part of the map to see the cumulative number of COVID-19 vaccine doses distributed in Canada and each jurisdiction over time.
Mar 2, 2021 · EMA and Health Canada are working together with manufacturers to expedite the publication of clinical information underpinning their authorisations for medicines and vaccines for COVID-19. The clinical data for the Pfizer-BioNTech COVID-19 vaccine is expected to be published shortly.
Health Canada has updated guidance outlining how currently authorized COVID-19 vaccines that are modified in response to new variants of the virus will be reviewed and authorized in Canada.
