Mr. Speaker, the health and safety of Canadians are Health Canada’s top priorities, and the department exercises stringent regulatory oversight over vaccines. Before any of the COVID-19 vaccines were approved in Canada, the department conducted rigorous scientific review of the extensive data regarding the vaccines’ safety, efficacy and quality, including results of pre-clinical and clinical studies, details on manufacturing processes, and information on adverse events following immunization. An authorization was only issued when the benefits of any of the COVID-19 vaccines outweighed the risks of their use, thereby allowing the use of “safe and effective” in describing the authorized vaccine preparations.
The COVID-19 vaccines and treatments portal, https://covid-vaccine.canada.ca/, contains the summary basis of decision for each of the authorized COVID-19 vaccines. Please note that biopharmaceutic studies and associated analytical methods are proprietary and cannot be disclosed. All COVID-19 vaccines authorized by Health Canada under the interim order met the requirements of section C.08.001(2) of the food and drug regulations (2)(g) and (2)(h) for safety and efficacy. Terms and conditions were imposed upon the authorization with respect to quality, clinical, labelling, and risk management plan requirements. This process has allowed Health Canada to assess information submitted by the manufacturer as it became available during the product life cycle to ensure that the benefits of the vaccines continued to outweigh the risks. Additional safety and effectiveness data generated post-approval continue to support Health Canada's original decision.
Lastly, the mRNA COVID-19 vaccines authorized by Health Canada met the requirements of section C.04.015 of the food and drug regulations. However, the lot evaluation group assigned to mRNA vaccines, as part of the lot release program and protocols of testing submitted by the manufacturers, is proprietary and cannot be disclosed.