Mr. Speaker, with regard to parts (a) to (k), the health and safety of Canadians are Health Canada’s top priority and the department exercises stringent regulatory oversight over biologics, including 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 preclinical and clinical studies, details on manufacturing processes and information on adverse events following immunization. An authorization was only issued when the benefits of the COVID-19 vaccine outweighed the risks of its use.
For all products authorized by Health Canada, the summary basis of decision is published on the website https://dhpp.hpfb-dgpsa.ca/review-documents. This document details the clinical and preclinical data analyzed and provides a rationale for the review decision. Furthermore, as part of the regulatory requirements, a product monograph is publicly released at the time of a vaccine’s authorization. A product monograph is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use for the drug, and contains any other information that may be required for optimal, safe and effective use of the drug. It is used to inform physicians, pharmacists, dentists, nurses, other health care professionals and patients about the appropriate use of the product.
The product monograph is developed and managed by the manufacturer. The content, wordings and format are carefully reviewed by Health Canada to ensure that it is prepared in accordance with the guidance. Each publicly available Canadian product monograph can be consulted by accessing the drug product database at https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html. It describes the specific evaluation methods and data used to assess safety and effectiveness for each product. As part of this assessment, Health Canada relies on clinical trials that are assessed against established international and national standards.
At the time of authorization, the safety information included in the product monograph and in package inserts is based on the available safety data from clinical trials. Furthermore, Health Canada is responsible for ensuring that the product monograph and package inserts are updated over time to adequately reflect the risks associated with the vaccines that are authorized in Canada. Health Canada-approved information is used by appropriate bodies, such as provincial and local public health authorities, to guide recommendations, vaccine use, as well as information provided to vaccine recipients. The product monograph also contains a list of adverse reactions observed during clinical trials for the product. Each drug product authorized for sale in Canada has labelling that reflects Health Canada's assessment of the product at the time of approval.
For new drug submissions, the product sponsor proposes a therapeutic indication supported by clinical trials and other data. During review of the submission, Health Canada conducts its assessment. A drug’s pharmacological mechanism of action is considered within this context. It is noted that no health product is without risks. Adverse events from the clinical trials submitted by the sponsor are carefully assessed, considered within the context of the condition treated or prevented by the product, and labelled in the product monograph, linked above.
Following authorization, Canada has a robust and well-established vaccine safety surveillance system involving Health Canada, the Public Health Agency of Canada, or PHAC, the provinces and territories, and vaccine manufacturers. Health Canada continues to monitor the safety profile of health products once they are in the Canadian market, to help ensure that the benefits of the products continue to outweigh the risks. The safety profile of these products is monitored by reviewing safety information submitted by manufacturers and by considering safety information from international regulators.
In addition, Health Canada and PHAC have been actively monitoring and reviewing reports of adverse events following immunization, or AEFIs, reported to the Canada vigilance program, or CVP, of Health Canada and the Canadian adverse events following immunization surveillance system of PHAC. Adverse events of special interest, or AESIs, which are potentially associated with vaccine products, must also be carefully monitored and confirmed by further evaluation. Information on AEFIs and AESIs is published on the Government of Canada’s website at https://health-infobase.canada.ca/covid-19/vaccine-safety/.
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. When new safety issues are confirmed by the department, Health Canada takes action, which may include communicating new risks to Canadians and health care professionals or changing the recommended use of the product.
The Brighton Collaboration, or BC, was established in 2001 to provide standardized, validated and objective methods for monitoring the safety profile and benefit-to-risk ratios of vaccines. This includes the development of globally implemented case definitions, guidance and protocols for data collection and comparability within and across clinical trials, surveillance systems, and post-licensure clinical studies. Health Canada has been implementing the BC criteria on case definition when assessing AEFI reports retrieved from the CVP.
Information about AEFIs reported in Canada, including the BC criteria, is published on the Government of Canada’s website at https://health-infobase.canada.ca/covid-19/vaccine-safety/.
With respect to product quality, Health Canada performs a thorough review of manufacturing processes and controls. Impurity levels in all product types are controlled by predetermined limits in place during product manufacturing and before the product is released onto the market. Health Canada ensures that scientifically justified methods are in place to monitor impurities and that the limits set are appropriate to ensure the safety of patients. The impurities are adequately controlled by the existing control system.
Agile licensing for drugs and medical devices are regulatory amendments being proposed to the food and drug regulations and the medical devices regulations. The agile regulatory proposal was pre-published in the Canada Gazette, part I, for a 130-day consultation, which closed on April 26, 2023. The proposed regulations are intended to reduce irritants and regulatory roadblocks to innovation by introducing regulations that are more agile and internationally aligned increasing postmarket oversight without compromising premarket rigour. The measures that will be introduced as part of these modernization efforts will not lessen Health Canada’s commitment to the health and safety of Canadians. The department will continue to require the same high standards of evidence about the safety, efficacy and quality of drugs and medical devices prior to authorization for sale and once on market.
Health Canada is targeting a fall 2024 Treasury Board date, with publication of the finalized regulations in the Canada Gazette, part II. As these amendments have not yet received Governor in Council approval, they are not currently considered under the regulations.