Mr. Speaker, in response to parts (a) to (q) of the question, the health and safety of Canadians are the utmost priority for Health Canada. Health Canada has a rigorous scientific review system in place to ensure vaccines are safe and effective in preventing the diseases they target. More information on these standards and how Health Canada regulates vaccines for human use in Canada can be found at https://bit.ly/36xea3C. Once vaccines are authorized, Health Canada releases information about the vaccine, including summaries of the data considered by Health Canada. This includes non-clinical, clinical and other studies, as well as how the decision was made. This information can be found on Health Canada’s website at http://bit.ly/30LJM2z.
Studies to support the safety of the COVID-19 vaccines were conducted and were submitted as part of the pre-clinical and clinical data packages that companies are required to submit to regulatory agencies, including Health Canada. These data were analyzed by Health Canada prior to authorizations being granted for the COVID-19 vaccines.
The evaluation of toxicity of the COVID-19 mRNA vaccines was focused on the vaccines themselves, the components and the delivery system. In non-clinical studies, the toxicity of vaccines was tested either as the whole product containing the delivery system as marketed in Canada, medicinal ingredients, i.e COVID-19 antigens, or non-medicinal ingredients, including the components in the formulation.
Polyethylene glycol, or PEG, is an ingredient that is widely used in cosmetics, food products, and pharmaceuticals. Monoclonal antibodies, for example, are frequently conjugated with PEG to increase stability. Products containing PEGylated lipid nanoparticles, or LNPs, such as Onpattro, have been on the Canadian market for several years and are not unique to the COVID-19 vaccines.
In the product monograph, the composition/components contained in the vaccine, including the LNPs, are listed in the Table of “Dosage Form, Strength, Composition and Packaging”. The important data from the required toxicity tests for the vaccine product are also presented.
The manufacturing data provided to Health Canada demonstrated the ability to produce a vaccine with consistent quality. Impurities, including residual DNA, are controlled through maximum permissible limits during the manufacturing process and before the product is released on the market to ensure safety. These impurities are evaluated using validated assays, and limits are set to ensure product quality and safety. These requirements are informed by science and are aligned with international standards, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
More information is publicly available in the Summary Basis of Decision available on the COVID-19 Vaccines and Treatments Portal on canada.ca.
Following authorization, Canada has a robust and well-established vaccine safety surveillance system involving Health Canada, Public Health Agency of Canada, or PHAC, provinces and territories, and vaccine manufacturers. Health Canada continues to monitor the safety profile of health products once they are on the Canadian market, to help ensure that the benefits of the product continue to outweigh the risks. The safety profile of these products is monitored by reviewing safety information submitted by manufacturers as well as considering safety information from international regulators. When new safety issues are confirmed by the department, Health Canada takes action, which may include communicating new risks to Canadians and healthcare professionals or changing the recommended use of the product. In addition, Health Canada and the PHAC have been actively monitoring and reviewing reports of adverse events following immunization, or AEFI, reported to the Canada Vigilance Program of Health Canada and the Canadian Adverse Events Following Immunization Surveillance System of the PHAC. This information is published on the Government of Canada’s website. It is important to note that these reports do not necessarily imply that a relationship between the adverse event and the vaccine has been established. However, they are an important information source supporting ongoing safety monitoring.