Mr. Speaker, the health and safety of Canadians is Health Canada’s top priority, and the Department of Health exercises stringent regulatory oversight over vaccines. Before a vaccine is approved in Canada, the department conducts a rigorous scientific review of its safety, efficacy and quality. Submissions typically contain extensive data regarding the vaccine's 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 is only issued when benefits of the vaccine outweigh the risks of its use.
In response to (a) and (b), 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 that may come from their spontaneous reporting databases, such as Vaccine Adverse Event Reporting System, or VAERS, data from the USA, EudraVigilance data from Europe or the Yellow Card data from England. When new safety issues are identified, Health Canada takes action, which may include communicating new risks to Canadians and healthcare professionals or changing the recommended use of the product. Detailed information about known and potential risks associated with the use of COVID-19 vaccines is included in their Canadian Product Monographs, or CPM. Further information on CPMs of COVID-19 vaccines can be found on the Health Canada website COVID-19 vaccines and treatments portal at canada.ca.
In response to (c) to (g), Health Canada and the PHAC have been actively monitoring and reviewing reports of adverse events following immunization, or AEFI, for COVID vaccines. There are two databases which capture Canadian AEFI reports. 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. In general, AEFI reports received by Health Canada are included in the CVP database unless it is missing any of the 4 minimum criteria, such as identifiable patient, identifiable reporter, product suspected of being responsible for the reaction, and adverse reactions. Information about COVID-19 vaccine AEFIs reported in Canada, including the number of reports of vaccine-associated fatal and non-fatal heart attacks, strokes and other cardiovascular events, is published on the Government of Canada’s website. AEFI reports by age and sex are also included on the 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.
The PHAC has published results of the following event-specific analyses investigating the potential increase in events described in (c) compared with their baseline values prior to COVID-19 vaccine rollouts.
It is also important to consider that the risk of cardiac complications has consistently been shown to be increased following COVID-19 illness. It is important to keep in mind that there is temporal overlap between the emergence of the SARS-CoV-2 virus that causes COVID-19 and the rollout of the COVID-19 vaccines, and scientific care must be taken to separate the contribution of viral illness versus rare incidences of certain AEFIs following vaccination to the total number of these events observed in the Canadian population.
In response to (h) and (i), in regard to a product withdrawal from the Canadian market, there is no specific threshold nor an established benchmark regarding the number of fatalities or number of serious adverse events, or SAEs, by which drugs or medical devices, including mRNA-based vaccines, would no longer be available on the Canadian market. This determination would be based on a scientific review of the balance of risks and benefits. As noted above, if the available evidence, including data obtained through surveillance, indicates that the risks outweigh the benefits, Health Canada will take appropriate action.
In response to (j), Health Canada reviewed safety reports including data from Pfizer’s three-month post-marketing phase submitted by the manufacturer. The information reviewed did not identify new safety concerns and was consistent with the known safety profile of COMIRNATY. Outcomes of Health Canada’s safety reviews for COMIRNATY are available online at the Post Authorization Activity Table for COMIRNATY. To date, the benefits of these vaccines continue to outweigh their known risks.
The National Advisory Committee on Immunization, or NACI, is an external advisory body that provides independent, expert advice on the optimal use of vaccines approved for use in humans in Canada. NACI guidance is based on a rigorous review and assessment of the quality of the available evidence. Decision-making relies on the consideration of multiple factors including burden of disease, vaccine safety, vaccine efficacy/effectiveness and programmatic factors. NACI’s guidance is advisory in nature as provinces and territories are responsible for designing and delivering their immunization programs.
NACI continued to recommend the Pfizer COVID-19 vaccine as a review of the available evidence showed that the benefits of the immunization program outweighed the risks.