Mr. Speaker, with regard to (a) to (g), the Public Health Agency of Canada, or PHAC, does not have access to provincial or territorial databases like the Ontario Health Data Platform that provide an individual-level information such as medical diagnoses or date of deaths. Similarly, PHAC does not have access to databases managed by the Institute for Clinical Evaluative Sciences.
Canada has a robust and well-established surveillance system to monitor for safety concerns for COVID-19 vaccines authorized in Canada, which involves monitoring by Health Canada, 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 and from adverse events following immunization, or AEFI, reports from healthcare professionals and consumers. When new safety issues are confirmed, 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 AEFI reports. All AEFI reports submitted by provincial and territorial public health authorities and federal departments are captured in the Canadian Adverse Events Following Immunization Surveillance System, or CAEFISS, which is managed by PHAC. In addition, the Canada Vigilance Program, or CVP, managed by Health Canada, receives AEFI reports from manufacturers, Canadian hospitals, healthcare professionals and consumers. Information about AEFIs reported in Canada, including the reporting rates, is published on the Government of Canada’s website. In addition, the anonymized reports received from the CVP of Health Canada, including suspect AEFIs reported directly to the CVP, are available at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html. 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.
Building on the existing robust pharmacovigilance system, Health Canada introduced strategies to enhance regulatory surveillance measures for COVID-19 vaccines. For example, terms and conditions in the document “Guidance for market authorization requirements for COVID-19 vaccines”, found at canada.ca, have been imposed on manufacturers to quickly request and gather critical safety and effectiveness information in order to mitigate risks during the product lifecycle. These enhanced regulatory surveillance measures enabled Health Canada to request additional risk monitoring activities and post-market studies, namely post-authorization studies on safety and effectiveness. These measures also provided tools for Health Canada to detect and evaluate emerging safety information on the benefit-risk balance of COVID-19 vaccines. As noted before, should there be new safety issues, Health Canada will take appropriate action(s).
With regard to (h), PHAC does not possess or have access to datasets with this type of information.
With regard to (i), Health Canada and PHAC have a robust vaccine safety surveillance system in place that engages healthcare professionals, vaccine manufacturers, and provincial and territorial health authorities. PHAC receives and reviews AEFI reports from provinces and territories, as submitted by health care providers through CAEFISS). The information provided by CAEFISS is complemented by the Canada Vigilance Program, Health Canada’s post-market surveillance program that collects and assesses reports of suspected adverse events to health products marketed in Canada. Manufacturers are required to report serious adverse events to Health Canada as the national regulatory authority, as well as submit regular summaries of global safety information. AEFI reports are monitored continuously by PHAC and Health Canada. Any new or unusual adverse events, or changes in trends or severity of specific events would trigger an investigation, including an in-depth medical review and risk assessment. As safety issues are investigated, Health Canada will take appropriate action as needed.
With regard to (j), PHAC is aware of provincial and territorial databases that include information about vaccinations and clinical outcomes following vaccination, among many other topics. However, PHAC receives AEFI reports from all provincial and territorial governments. For the purposes of adverse events following immunizations, provincial and territorial governments make the determination of the appropriate data sources for clinical and vaccination data necessary to generate and validate those reports that are submitted to PHAC for the purposes of surveillance.
Part (k) is not applicable.