Health Canada

Health Canada is an agency of the Government of Canada responsible for national health policy.

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⁾

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.²⁾

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.³⁾ 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.⁴⁾

On July 14, 2022, Health Canada authorized the use of the mRNA-1273 COVID-19 vaccine manufactured by Moderna for children 6 months to five years old.⁵⁾ 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.⁶⁾

The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) regulates biological drugs (products made from living sources, including vaccines), radiopharmaceuticals (drugs that have radioactivity), and cells, tissues and organs for human use in Canada. The Directorate is also the regulatory authority responsible for the Assisted Human Reproduction (AHR) Act and its supporting regulations.⁷⁾

Health Canada collects reports of adverse events associated with pharmaceutical products through the Canada Vigilance Program (CVP).⁸⁾

Health Canada's Board saw high turnover in the Ethics positions in 2020 and 2021.⁹⁾

• Good manufacturing practices guide for drug products (GUI-0001)
• April 2020: Side Effect Reporting Form

• Wikipedia