Mr. Speaker, the health and safety of Canadians is Health Canada’s top priority, and the department exercises stringent regulatory oversight over vaccines, including the COVID-19 vaccines. Before a vaccine is approved in Canada, the department conducts a rigorous scientific review of its safety, efficacy and quality. Submissions filed by vaccine manufacturers typically contain extensive data regarding the vaccine's safety, efficacy and quality, including results of pre-clinical and clinical studies, details on manufacturing processes, and information on adverse events following immunization. For your information, the clinical data that was submitted in support of the approval of COVID-19 vaccine by manufacturers, can be found on the Clinical Information Portal. An authorization was only issued when anticipated benefits of the vaccine outweighed the potential risks of its use.
The mRNA in the COVID-19 mRNA vaccines provides instructions for how to make the viral spike protein of SARS-CoV-2. The spike protein triggers an immune response. The body then prepares antibodies and cells that help fight the virus if it enters the body in the future. Additional details on how the COVID-19 mRNA vaccines work ca be found at COVID 19 mRNA vaccines – Canada.ca. The vaccines have demonstrated to be highly effective in prevention of COVID-19 caused by SARS-CoV-2.
Studies on the biodistribution and pharmacokinetics of the drug product were conducted and were submitted as part of the pre-clinical and early clinical trial phase data packages that companies are required to submit to regulatory agencies, including Health Canada. The pre-clinical data provided by the companies demonstrated that vaccine-produced spike protein is rapidly broken down and does not persist in the body. These data were analyzed by Health Canada prior to authorizations being granted for the COVID 19 vaccines. The outcomes of some of these studies can be found in the Summary Basis of Decision for each product, available on the COVID 19 vaccines and treatments portal.