Mr. Speaker, with regard to parts (a) to (z), 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://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/activities/fact-sheets/regulation-vaccines-human-canada.html. Once vaccines are authorized, Health Canada releases information about the vaccines, 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 https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html.
Information requested regarding the strength of each of the COVID-19 vaccines, dosing information and information on the mechanism of action can be found in the product monographs: Nuvaxovid XBB.1.5, at https://covid-vaccine.canada.ca/info/pdf/nuvaxovid-xbb-1-5-pm-en.pdf; Comirnaty Omicron XBB.1.5, at https://covid-vaccine.canada.ca/info/pdf/comirnaty-omicron-xbb-1-5-pm-en.pdf; and Spikevax XBB.1.5, at https://covid-vaccine.canada.ca/info/pdf/spikevax-xbb-1-5-pm-en.pdf.
The manufacturing data provided to Health Canada demonstrated the ability to produce a vaccine with consistent quality. Levels of impurities, including dsDNA, are strictly controlled during the manufacturing process and before the product is released on the market, to ensure product quality and safety. The sponsor provided sufficient information to support the consistency of production and quality of the product. 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.
The mRNA in the COVID-19 vaccines uses modified nucleosides to avoid activation of the cellular immune response and destruction of the mRNA, to enhance translation and to improve stability. Various modifications to the mRNA sequence have been introduced for maintaining antigen conformation, that is, ensuring the ‘shape’ of the antigen is capable of generating the desired immune responses. Detailed characterization studies were performed to provide assurance that the drug substance consistently exhibits the desired characteristic structure and biological activity. Additional information can be found in the summary basis of decision, or SBD, documents published by Health Canada, which provide an overview of the data examined. These can be found by accessing the COVID-19 Vaccines and Treatments Portal, at https://covid-vaccine.canada.ca/.
Studies on the biodistribution and pharmacokinetics of the lipid nanoparticle-formulated modified mRNA were conducted and were submitted as part of the preclinical and early clinical trial phase data packages that companies are required to submit to regulatory agencies, including Health Canada. The preclinical data provided demonstrated that vaccine-produced spike protein is rapidly broken down and does not persist in the body. This data was 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 Drug and Health Product Portal, at https://dhpp.hpfb-dgpsa.ca/review-documents.
The benefits of vaccines authorized in Canada continue to outweigh the risks. Health Canada, PHAC, the provinces and territories, and manufacturers continue to closely monitor the safety of COVID-19 vaccines. Health Canada and PHAC receive reports of adverse events following immunization with COVID-19 vaccines in Canada through the Canada vigilance program, or CVP, and the Canadian adverse events following immunization surveillance system, or CAEFISS. Adverse events following immunization are routinely monitored. Information on adverse events following immunization with COVID-19 vaccines, including breakdowns of reports by vaccine name, age and sex, are published on the Government of Canada website at https://health-infobase.canada.ca/covid-19/vaccine-safety/. All signals are monitored and investigated.