¶ Health Canada
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Health Canada is an agency of the Government of Canada responsible for national health policy.
¶ History
Prior to the COVID-19 pandemic, Health Canada's website hosted a web portal through which consumers could report suspected adverse events to vaccines.[1] In December 2019, the agency's “Report a side effect” web page was updated "to enhance its user- friendliness and reflect the mandatory reporting of serious adverse events of drugs and medical devices by hospitals."[2]
¶ COVID-19
On September 16, 2020, Minister of Health Patricia Hajdu issued an interim order redefining the regulatory standards for drugs and vaccines related to COVID-19, titled "Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19".[3]
On December 1, 2020, Health Canada altered their consumer reporting page to remove the ability to submit adverse event reports online. This change meant consumers were forced to submit reports to their healthcare practitioner, who would then fill out a printed form and mail it in.[4]
On February 26, 2021, Health Canada authorized the AstraZeneca COVID-19 vaccine under interim order.[5]
On March 5, 2021, Health Canada authorized the Janssen COVID-19 vaccine under interim order. The decision was made based on an interim analysis of Janssen's clinical trial data collected up to January 22, 2021.[6]
On November 18, 2021, Health Canada transitioned the AstraZeneca product's authorization under interm order to being authorized under the Food and Drug Regulations.[7]
On February 17, 2022, Health Canada authorized the Novavax COVID-19 vaccine for use in adults.[8]
On February 24, 2022, Health Canada issued a public advisory titled "Rapid antigen test kits and potential exposure to hazardous substances," warning of "an increase in reports to poison control centres" related to toxic chemical solutions in COVID-19 rapid antigen tests including "liquid solutions with chemical preservatives, such as sodium azide and Proclin that may be poisonous if swallowed or absorbed through the skin."[9]
On June 24, 2022, Health Canada appeared to delete nearly 2,000 “adverse events of special interest,” comprising 28.3% of their total collected of such reports to date.[10] This move followed the publication of a pre-print study by Peter Doshi et al reviewing AESIs in the clinical trials by Pfizer and Moderna just one day prior.[11]
On July 14, 2022, Health Canada authorized the use of the Moderna COVID-19 vaccine (mRNA-1273) manufactured by Moderna for children 6 months to five years old.[12] This marked the first such product authorized for that age group in Canada.
On February 28, 2023, Health Canada's consumer reporting page was updated once again, this time restoring the online reporting function and noting that healthcare practitioners are required by law to report adverse events.[13]
On June 12, 2023, Health Canada and the Public Health Agency of Canada disclosed that both agencies were aware of the document titled "5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021" published by Pfizer under court order in January 2022, but its contents did not affect the agencies' recommendations for the use of the Pfizer-BioNTech COVID-19 vaccine.[14]
Health Canada received an application on June 29, 2023 from Moderna for a new formulation of the Moderna COVID-19 vaccine based on the "Omicron XBB.1.5 subvariant" of SARS-CoV-2. It was subsequently authorized by Health Canada on September 12, 2023.[15][16]
On November 18, 2023, The Canadian Independent published a disclosure package from Health Canada containing over 2,100 pages of deaths associated with COVID-19 vaccination reported through the Canada Vigilance Program (CVP).[17]
¶ Organization
Health Canada monitors reports of Adverse Events Following Immunization through the Canada Vigilance Program (CVP).[18]
¶ Subsidiaries
Subsidiary agencies and divisions within Health Canada include:
¶ Personnel
Health Canada's Board saw high turnover in the Ethics positions in 2020 and 2021.[21]
| Name | Position | Notes |
|---|---|---|
| Patrycja Arkuszewski | Executive Director of Digital Transformation[22] | Environment and Climate Change Canada, Library and Archives Canada (LAC), Privy Council Office, Natural Resources Canada |
| Nancy Aubertin | Program Manager[23] | Innovation, Science and Economic Development Canada (ISED), Elections Canada, Ford Credit |
| Andrea Burrows | ATIP Team Leader[24] | - |
| Tania Scolli | Executive Assistant[25] | VIVA Retirement Communities, Queensway Carleton Hospital, Osgoode Chiropractic Clinic, Ottawa Public Health, Alterna Savings |
¶ Publications
¶ Access to Information
- June 12, 2023: Order Paper Question re: 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
- June 16, 2023: Order Paper Question re: Adverse event reporting webpage
- November 2, 2023: ATIP re: Vax Reporting Website Changes
- November 2023 (?): Health Canada Fatalities After Covid-19 Vaccine
¶ External links
Health Canada. (2019, December 30). Report a side effect to a vaccine: consumers. Government of Canada. http://archive.today/2020.09.20-152607/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/vaccine/consumer.html ↩︎
Lamoureux, K. (2023). Order Paper Question - Q-1482 (p. 2). Government of Canada. https://archive.org/details/order-paper-question-q-1482 ↩︎
Hadju, P. (2020, September 17). ARCHIVED Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Government of Canada. http://archive.today/2021.02.26-180932/https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-import-sale-advertising-drugs.html ↩︎
Health Canada. (2020, December 1). Report a side effect to a vaccine: consumers. Government of Canada. http://archive.today/2020.12.27-183130/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/vaccine/consumer.html ↩︎
Regulatory Decision Summary - AstraZeneca COVID-19 Vaccine - Health Canada. (2021, February 26). Government of Canada. https://web.archive.org/web/20230610043020/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00772 ↩︎
Health Canada. (2021, March 5). Regulatory Decision Summary - Janssen COVID-19 Vaccine. Government of Canada. http://archive.today/2023.06.10-012952/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00779 ↩︎
Regulatory Decision Summary - Vaxzevria - Health Canada. (2021, November 18). Government of Canada. https://web.archive.org/web/20230610054136/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00889 ↩︎
Parkhill, M. (2022, February 17). Novavax vaccine authorized for use in Canada. CTV News. http://archive.today/2022.02.17-170358/https://www.ctvnews.ca/health/coronavirus/novavax-vaccine-authorized-for-use-in-canada-1.5785244 ↩︎
Health Canada. (2022, February 24). Rapid antigen test kits and potential exposure to hazardous substances. Government of Canada. http://archive.today/2022.02.25-010727/https://recalls-rappels.canada.ca/en/alert-recall/rapid-antigen-test-kits-and-potential-exposure-hazardous-substances ↩︎
Tim Truth. (2022, September 4). Canada Govt DELETES Thousands Of Reported Adverse Events Of Special Interest Pertaining To Hearts, CNS & Autoimmune Disorders. Substack. https://archive.ph/N4qRl ↩︎
Fraiman, J., Erviti, J., Jones, M., Greenland, S., Whelan, P., Kaplan, R. M., & Doshi, P. (2022, June 23). Serious Adverse Events of Special Interest following mRNA vaccination in randomized trials. SSRN. https://web.archive.org/web/20220907210255/https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239 ↩︎
Health Canada. (2022, July 13). Health Canada authorizes use of Moderna COVID-19 vaccine in children 6 months to 5 years of age. Government of Canada. https://web.archive.org/web/20220716004905/https://www.canada.ca/en/health-canada/news/2022/07/health-canada-authorizes-use-of-moderna-covid-19-vaccine-in-children-6-months-to-5-years-of-age.html ↩︎
Health Canada. (2023, February 28). Report a side effect to a vaccine: Consumers. Government of Canada. http://archive.today/2023.05.01-234821/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/vaccine/consumer.html ↩︎
van Koeverden, A. (2023). Order Paper Question - Q-1448. Internet Archive; Government of Canada. https://archive.org/details/order-paper-question-q-1448 ↩︎
Health Canada. (2023, September 12). Health Canada authorizes Moderna COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant. Government of Canada. http://archive.today/2023.09.15-020747/https://www.canada.ca/en/health-canada/news/2023/09/health-canada-authorizes-moderna-covid-19-vaccine-targeting-the-omicron-xbb15-subvariant.html ↩︎
Health Canada. (2023, September 12). Moderna Spikevax COVID-19 vaccines. Government of Canada. https://web.archive.org/web/20230915020847/https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/moderna.html ↩︎
The Canadian Independent. (2023, November 19). LOOK: An access to information request has revealed over 2,100 pages of death reports submitted to the Canadian government following Covid-19 vaccination. Substack. http://archive.today/2023.11.19-235322/https://thecanadianindependent.substack.com/p/look-an-access-to-information-request ↩︎
Health Canada. (2022, June 15). Canada Vigilance Program. Government of Canada. http://archive.today/2023.05.09-195237/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html ↩︎
Health Canada. (2013, July 26). Communications and Public Affairs Branch. Government of Canada. https://web.archive.org/web/20231114172619/https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/communications-public-affairs-branch.html ↩︎
Health Canada. (2021, June 23). Biologic and Radiopharmaceutical Drugs Directorate. Government of Canada. https://archive.ph/DUsZi ↩︎
Health Canada Board Members History. Campfire Wiki; Operation Uplift. Retrieved April 4, 2022, from https://www.campfire.wiki/lib/exe/fetch.php?media=health_canada_board_members_history_1_.pdf ↩︎
Patrycja Arkuszewski. LinkedIn. Retrieved November 14, 2023, from http://archive.today/2023.11.14-182930/https://www.linkedin.com/in/patrycja-arkuszewski-2040376/ ↩︎
Nancy Aubertin. LinkedIn. Retrieved November 14, 2023, from http://archive.today/2023.11.14-183625/https://www.linkedin.com/in/nancy-aubertin-7b8b819a/ ↩︎
Shared Services Canada. (2021, August 30). Andrea Burrows · Health Canada · ATIP Team Leader. OpenGovCa. https://web.archive.org/web/20220425181829/https://opengovca.com/employee/andrea-burrows ↩︎
Tania Scolli. LinkedIn. Retrieved November 26, 2023, from http://archive.today/2023.11.26-233318/https://www.linkedin.com/in/tania-scolli-779059138/details/experience/ ↩︎