Mr. Speaker, with regard to part (a), Health Canada’s regulatory evaluation of vaccines includes the review of randomized control studies if there are indications for pregnant and lactating women. Observational studies may be required as part of the risk management plan that is reviewed by Health Canada prior to authorization. In addition, after authorization, Canada has a robust and well-established vaccine safety surveillance system involving Health Canada, Public Health Agency of Canada, PHAC, provinces and territories, and vaccine manufacturers. Health Canada monitors the safety of COVID-19 vaccines through monitoring and risk minimization measures, including requiring manufacturers to regularly submit safety reports and reports of adverse events following immunization, AEFIs, and regularly assessing whether there is any new safety information that may affect the benefit-risk profile of the product. Health Canada has been actively monitoring and reviewing safety data submitted by the manufacturers of the COVID-19 vaccines. Health Canada also monitors and considers information from the scientific literature and international regulators.
With regard to part (b), none of the COVID-19 vaccine manufacturers sought indications for use in pregnant or lactating women or submitted RCTs in pregnant/lactating women for regulatory evaluation. The product monographs included statements about the uncertainties related to pregnancy and lactation. The product monographs can be accessed using the following link: COVID-19 vaccines and treatments portal (canada.ca).
With regard to part (c), as indicated above, there were no RCTs in pregnant/lactating women submitted for regulatory evaluation as the vaccine sponsors did not seek an indication for use in pregnant and lactating women.
With regard to parts (d) and (g), the regulatory basis for the decision taken by Health Canada is publicly available at https://covid-vaccine.canada.ca/ for each specific vaccine. Please see Regulatory Decision Summary and Summary Basis of Decision documents.
As indicated in the specific product monographs, it is noted that the safety and efficacy of these vaccines in pregnant women have not yet been established. No indication for use in pregnant or lactating women was sought by the vaccine sponsors or authorized by Health Canada.
It is important to note that evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy has been growing from real-world use. No safety concerns were identified in a study of more than 35,000 pregnant persons who received an mRNA COVID-19 vaccine during pregnancy or in the immediate period prior to conception. More information about COVID-19 vaccination and pregnancy is available here https://www.canada.ca/en/public-health/services/immunization-vaccines/vaccination-pregnancy-covid-19.html
Health Canada has been actively monitoring and reviewing safety data submitted by the manufacturers as well as adverse events following immunization, AEFI, reported to the Canada vigilance program, CVP, of Health Canada while also considering information from Canadian Adverse Events Following Immunization Surveillance System, CAEFISS, of the Public Health Agency of Canada, PHAC, and foreign data from international partners. Should there be new safety issues identified, Health Canada takes actions, as appropriate.
With regard part (e), Health Canada publishes the product monographs on its website https://covid-vaccine.canada.ca/ in order to inform the public, health care professionals and the research community. As noted in the product monograph, the safety and efficacy of Comirnaty in pregnant women have not yet been established. In addition, Health Canada also publishes the summary basis of decision that provides information about the authorization of the Comirnaty Omicron XBB.1.5. Please see https://covid-vaccine.canada.ca/info/SBD1700495075939-comirnaty-omicron-xbb-1-5-en.html
The National Advisory Committee on Immunization, NACI, is an external advisory body that provides independent, expert advice to PHAC on the optimal use of authorized vaccines in Canada. When making recommendations, NACI considers the benefits and potential risks of a vaccine and any unknowns at the time. NACI has made recommendations for the use of COVID-19 vaccine in pregnant and lactating women based on the totality of evidence available across all authorized COVID-19 vaccines. Considerations specific for pregnant and/or lactating women are included in the Canadian Immunization Guide COVID-19 chapter, which is based on the NACI recommendations. Links to the product monographs for authorized XBB.1.5 vaccines are included in the latest advice from NACI.
With regard to part (f), Health Canada publishes the product monographs on its website https://covid-vaccine.canada.ca/ in order to inform the public, health care professionals and the research community.
With regard to part (h), Health Canada has not approved any safety claims with regard to pregnant and lactating women.