PDF file: 441-1106_vaccine_clinical_trials_safety_and_immunogenicity.pdf OPQ ID: 441-1106 Session: 441 Question number: Q-1106 Sessional paper: Q-1106 Title: vaccine clinical trials safety and immunogenicity Short description: Topic: vaccines Identified concern: Keywords: Agencies: HC Date asked: 2022-12-12 Date tabled: Submitted by: Mr. Carrie (Oshawa) Reply by: Minister of Health Responded by: Mr. van Koeverden Pages: 7 Status: not processed Alert: grey Questions asked: 4 Questions answered: 4 Percent responded: 100% Referenced sources: Canada.ca, World Health Organization, COVID-19 vaccines and treatments portal Referenced links: https://bit.ly/3EH07IB, https://bit.ly/3GFvDHE, https://covid-vaccine.canada.ca/comirnaty/product-detailsModerna, https://covid-vaccine.canada.ca/covid-19-vaccine-moderna/productdetails, https://covidvaccine.canada.ca/covid-19-vaccine-moderna/product-details, https://covid-vaccine.canada.ca/comirnaty/product-details Official link: https://www.google.com/search?q=Q-1106+ourcommons.ca PDF URL: https://ivim.ca/foi/opq/r/441-1106_vaccine_clinical_trials_safety_and_immunogenicity.pdf TXT URL: https://ivim.ca/foi/opq/r/441-1106.txt Original filename: Q-1106 (Order) vaccine clinical trials safety and immunogenicity.pdf Local source path: C:\Users\Dmitry\Documents\CODES\OPQ-App\data-raw\OPQ\ALL OPQ TO DATE\2022\Q-1106 (Order) vaccine clinical trials safety and immunogenicity.pdf Machine extracted at: 2026-06-30 12:58:12 References / links: - https://bit.ly/3EH07IB - https://bit.ly/3GFvDHE - https://covid-vaccine.canada.ca/comirnaty/product-detailsModerna - https://covid-vaccine.canada.ca/covid-19-vaccine-moderna/productdetails(b - https://covidvaccine.canada.ca/covid-19-vaccine-moderna/product-details(d - https://covid-vaccine.canada.ca/comirnaty/product-details - https://covidvaccine.canada.ca/covid-19-vaccine-moderna/product-details - Canada.ca - World Health Organization - COVID-19 vaccines and treatments portal Machine notes: (none) Question text preview: With regard to the clinical trials conducted on COVID-19 vaccine safety, specifically those pertaining to the widely distributed vaccines by Pfizer/BioNTech and Moderna that Health Canada reviewed: (a) were objections raised by the government when these vaccines were allowed to be given to the relatively healthy, unvaccinated trial participants mid-way into Phase 3 of the placebo-controlled clinical trials; (b) if no action was taken in relation to (a), why not; (c) of the safety data that could be analyzed, showing level-1 evidence of vaccine-induced harm (e.g. a risk increase in severe adverse events, more death, and after dissolution of the control group, more deaths in the experimental group), how were they used, if at all, when performing risk-benefit analyses; and (d) what specific information was used by the government to arrive at their position that there was more benefit to administering the COVID-19 vaccines to relatively healthy Canadians than risk?