Mr. Speaker, Health Canada has authorized several COVID-19 vaccines for use in Canada. Each of these underwent a careful scientific review, and met our standards for safety, efficacy and quality. Information about all of the authorized vaccines, including the Regulatory Decision Summary, can be found on the COVID-19 vaccines and treatments portal at https://bit.ly/3EH07IB. Click on the individual vaccine names and then the “all resources” tab.
The portal provides detailed information for each of the vaccines that have been authorized, such as the product monograph, which is the prescribing information for both consumers and healthcare professionals in the manufacturer insert; the summary basis of decision, which provides a detailed overview of the data considered by Health Canada; and the terms and conditions placed on the authorizations, which are the requirements for further data submission that manufacturers are required to meet.
Bear in mind that information in the portal is being updated regularly. Specific details related to various aspects of the submission review, including the summaries of the clinical efficacy and safety, can be found in the portal. The portal also includes the supporting data related to the approval of COVID-19 vaccines on Health Canada’s Public Release of Clinical Information website at https://bit.ly/3GFvDHE.
As the federal regulator, Health Canada requires that clinical trial results be generated from properly designed protocols so that safety and efficacy of vaccines can be well demonstrated. Health Canada also requires manufacturing data demonstrating consistency and quality in the production of the vaccine. These requirements are informed by science and are aligned with international standards, including the World Health Organization guidelines.