Mr. Speaker, with regard to part (a), Health Canada did not receive the above-mentioned report. With regard to part (b), the answer is nil, as per (a). With regard to part (c), the answer is nil, as per (a).
With regard to part (d), Health Canada has a robust vaccine safety surveillance system in place that engages health care professionals, vaccine manufacturers, the Public Health Agency of Canada, PHAC, and the provincial and territorial health authorities. Through these measures, manufacturers are required to submit safety data from real-world use and results related to safety and effectiveness from ongoing and planned studies as they become available.
In addition, Health Canada and the Public Health Agency of Canada have been actively monitoring and reviewing reports of adverse events following immunization, AEFI, reported to the Canada vigilance program, at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html, and the Canadian adverse events following immunization surveillance system, at https://www.canada.ca/en/public-health/services/immunization/canadian-adverse-events-following-immunization-surveillance-system-caefiss.html. This information is published on the Government of Canada’s website at https://health-infobase.canada.ca/covid-19/vaccine-safety/. As noted on this website, there were 95 reports of spontaneous abortion up to and including September 15, 2023. 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 source of information supporting ongoing safety monitoring. Health Canada also monitors and considers information from the scientific literature and international regulators.
Health Canada will not request the above-mentioned report separately since the report is now outdated. However, on October 22, 2022, Health Canada published a summary of the review on the use of the mRNA COVID-19 vaccines Comirnaty and Spikevax during pregnancy and breastfeeding, which included adverse events reported to Health Canada. Information about the summary of the review is available by clinking on this website: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medeffect-canada/health-product-infowatch/october-2022/health-product-infowatch-october-2022.pdf.
Health Canada continues to monitor the safety of COVID-19 vaccines approved in Canada to help ensure that the benefits continue to outweigh the risks for all groups of individuals, including pregnant and lactating women. Should there be new safety issues identified, Health Canada will take action, as appropriate.
From the National Advisory Committee on Immunization, NACI, the summary of evidence and rationale for NACI’s pregnancy and breastfeeding recommendations was updated to reference developmental and reproductive toxicity, DART, animal studies for COVID-19 vaccines as those became available throughout 2020 and 2021. The relevant evidence was summarized in each update to NACI COVID 19 recommendations. In September 2022, as more evidence accumulated, NACI revised public health advice to strongly recommend that COVID-19 vaccines should be offered to those who are pregnant or breastfeeding, based on a review of global vaccine safety surveillance, vaccine effectiveness, vaccine safety studies and Canadian epidemiology. This included information from the Canadian National Vaccine Safety Network study, which started in December 2020, and the COVID-19 vaccine registry for pregnant and lactating individuals, which was launched in July 2021.
With regard to part (e), none of the COVID-19 vaccine manufacturers sought indications for use in pregnant or lactating women or submitted randomized clinical trial data in pregnant or lactating women for regulatory evaluation. The product monographs included statements about the uncertainties related to pregnancy and lactation. A change to the approved conditions of use for a drug, including vaccines, or removal of a drug from the market is based upon the available evidence regarding the risks and benefits of the drug. There is no specific threshold but rather a scientific evaluation of the balance of risks and benefits. If the available evidence, including data obtained through passive surveillance, indicates that the risks outweigh the benefits, Health Canada will take appropriate action. This action may include changes to the conditions of use of a drug, such as contraindicating use for some groups, or complete removal of the drug from the market. Should such action be taken, Health Canada would also communicate the risk to Canadians and health care providers.
With regard to part (f), while Health Canada has no information on institutions that met continuous review of the global vaccine safety surveillance rule, we understand that vaccine safety is monitored worldwide by health authorities. This information can be found on the official websites of international health authorities.