Alert level: yellow OPQ: Q-767 Session: 451 Suggested file name: myocarditis_and_pericarditis_and_international_cluster_meetings Tabled on: March 11, 2026 Agencies: HC Estimated questions: 5 Estimated responses: 4 Original filename: Q-767 - myocarditis and pericarditis and international cluster meetings, Response from March 11, 2026.pdf External links / references: (none detected) Extracted PDF text preview: Q-767 Question With regard to Health Canada, the Public Health Agency of Canada, Innovation, Science and Economic Development Canada, reports of myocarditis and pericarditis following COVID-19 vaccination and the March 3, 2021, International Regulatory Meeting for Pharmacovigilance Cluster on myocarditis following COVID-19 vaccination, at which Canada was represented: (a) what data were provided at this meeting in relation to myocarditis and pericarditis reports; (b) who attended this meeting on behalf of Canada; (c) what was the conclusion of the cluster meeting and did Health Canada agree with this conclusion; (d) whether the answer to (c) is armative or negative, what was Health Canada's rationale; (e) following this meeting, (i) what was Health Canada's action plan, (ii) was there a plan to investigate this signal further by Health Canada or any other regulatory body, and, if so, when, by whom and what was the plan; (f) were there meetings between Health Canada and other international regulatory agencies and the Marketing Authorization Holder, and, if so, what terms and conditions were placed upon the vaccine companies by Health Canada in relation to the reports of myocarditis and pericarditis; (g) what actions were taken by Health Canada or the Public Health Agency of Canada to identify cases of myocarditis or pericarditis following COVID-19 immunization in Canada with respect to (i) diagnostic parameters, (ii) research, (iii) reporting from health care providers, (iv) provincial guidance; and (h) for communications regarding the risk of myocarditis and pericarditis following COVID-19 vaccination for the public, (i) what input from non-government organizations and institutions was considered for public and media communications and messaging, (ii) what were the dates of the communication, (iii) what strategies and media scripts were developed, (iv) where are these communications posted or archived, (v) how and when was guidance to health care professionals updated to ensure informed consent with respect to myocarditis and pericarditis following COVID- 19 vaccination? Response This response was tabled in the House of Commons on March 11, 2026, as Sessional Paper 8555-451-767. Order/Address of the House of Commons Tabled on March 11, 2026 Sessional Paper 8555-451-767 House of Commons Health Canada Reply by: the Minister of Health Name of Signatory: Maggie Chi Reply Health Canada (a) what data were provided at this meeting in relation to myocarditis and pericarditis reports; (b) who attended this meeting on behalf of Canada; (c) what was the conclusion of the cluster meeting and did Health Canada agree with this conclusion; (d) whether the answer to (c) is armative or negative, what was Health Canada's rationale; (e) following this meeting, (i) what was Health Canada's action plan, (ii) was there a plan to investigate this signal further by Health Canada or any other regulatory body, and, if so, when, by whom and what was the plan? Health Canada delegates who have subject matter expertise attended the Pharmacovigilance Cluster on March 3, 2021. The Cluster meetings are designed for collaboration and exchange of information, including adverse event information, among international regulators on emerging safety issues or signals. Regulatory authorities from the European Medicines Agency, the United States Food and Drug Administration, the United Kingdom Medicines and Healthcare products Regulatory Agency and Health Canada provided the number of reports of myocarditis in their respective jurisdiction, as well as additional information on the reports. In addition, HC provided information on the roll-out of the COVID-19 vaccines in Canada and summarized the three reports of myocarditis and pericarditis received in Canada as of February 27, 2021. Health Canada, along with other regulatory agencies, committed to continue to closely monitor these events, as additional information was required to better characterize the potential risk. Question number Q-767 Asked by Ted Falk (Provencher) Date asked January 22, 2026 Presented by Kevin Lamoureux Parliamentary Secretary to the Leader of the Government in the House of Commons (f) were there meetings between Health Canada and other international regulatory agencies and the Marketing Authorization Holder, and, if so, what terms and conditions were placed upon the vaccine companies by Health Canada in relation to the reports of myocarditis and pericarditis; (g) what actions were taken by Health Canada or the Public Health Agency of Canada to identify cases of myocarditis or pericarditis following COVID-19 immunization in Canada with respect to (i) diagnostic parameters, (ii) research, (iii) reporting from health care providers, (iv) provincial guidance? The monitoring of adverse events following immunization in Canada is a collaborative effort between Health Canada and the Public Health Agency of Canada, with Health Canada and the Public Health Agency of Canada reviewing information stemming from different sources. Information submitted by manufacturers is reviewed by Health Canada to monitor the safety and efficacy of COVID-19 vaccines. Health Canada introduced strategies to enhance regulatory surveillance measures for COVID-19 vaccines. Terms and conditions (Guidance for market authorization requirements for COVID-19 vaccines (canada.ca)) were added to the authorizations requiring manufacturers to quickly gather critical safety and effectiveness information in order to mitigate risks during the product lifecycle, as well as to implement additional risk monitoring activities and post-market studies (post- authorization studies on safety and effectiveness). Health Canada also required the frequent submission of Periodic Benefit-Risk Evaluation Reports; these documents presented the manufacturer’s assessment of all relevant information including scientific literature and a conclusion on the benefit/risk profile of the product at a point in time. The regular submission of safety information, as required by the Terms and Conditions, contributed to Health Canada’s ability to promptly detect and evaluate the emerging safety information related to the risks of myocarditis and pericarditis. These enhanced measures enabled Health Canada to perform ongoing assessments of the benefit-risk balance of COVID-19 vaccines. Detailed information on Terms and Conditions for COVID-19 vaccines, can be accessed by visiting online, and selecting the desired vaccine; the Authorization Terms & Conditions can be found under the “all resources” tab. Health Canada also monitors and considers safety information from the scientific literature and international regulators. The monitoring and review of reports of adverse events following immunizations is actively performed by both Health Canada and Public Health Agency of Canada. All adverse events following immunization reports submitted by provincial and territorial public health authorities and federal departments are captured in the Canadian Adverse Events Following Immunization Surveillance System, which is managed by the Public Health Agency of Canada. In addition, the Canada Vigilance Program, managed by Health Canada, receives adverse events following immunization reports from manufacturers, Canadian hospitals, healthcare professionals and consumers. Through the monitoring of information originating from different sources, including information from the manufacturers, from scientific literature, from international regulators, as well as from adverse events following immunization reports, Health Canada continues to monitor the safety of COVID-19 vaccines once they are on the Canadian market to help ensure that the benefits continue to outweigh the risks. Should a new safety issue be confirmed, Health Canada will take appropriate action, which may include communicating new risks to Canadians and healthcare professionals or changing the recommended use of the product. Health Canada is