Changes To The Drug Approval Test

Discussion Paper on COVID-19 Vaccine Approvals

Discussion Paper by Shawn Buckley

Published March 2023

Changes to the drug approval test permitted COVID-19 vaccines to be approved without objective proof of safety, efficacy, or that benefits outweighed the risks.


Within this Discussion Paper, Shawn delineates alterations to the drug approval process that were applied to COVID-19 vaccine authorizations. He points out a disconnect between Health Canada’s messaging that “All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality.” and the fallout that we have seen.


Discussion around COVID-19 vaccines can still easily become polarizing. In fact, this is why the NHPPA opened a space for conversation. The discernment that comes from a deeper understanding of these legal issues paired with open dialogue can help all of us grasp the implications of seemingly small changes in language within our drug regulations.

Action Needed Now

This is a MUST-READ document for all Canadians concerned about the effects of regulatory changes on public health outcomes.

Excerpts From The Discussion Paper

  • “The test does not require Health Canada be given sufficient evidence “to conclude” that the benefits associated with the vaccine outweigh the risks of the vaccine. Rather the test only requires that there be “sufficient evidence to support the conclusion” that the benefits outweigh the risks. Evidence “to support” a conclusion is much different than evidence “to prove” a conclusion.”

  • “Whenever there is doubt concerning safety, efficacy or whether the benefits outweigh the risks, there is normally no approval – but for the COVID-19 vaccines, the Minister [i.e. Health Canada] had to approve even if unsure whether the benefits outweighed the risks.”

  • “This is a direction to approve vaccines while specifically and deliberately exempting them from: objective proof of safety, objective proof of efficacy, and objective proof that the benefits outweigh the risks. It is difficult to conceive of a less-scientific test for drug approval than that found in the Interim Order.”

  • “It is a fundamental safeguard that the Minister can ordinarily cancel a market authorization if new evidence raises a safety or efficacy concern or if fraud is discovered. This fundamental safeguard was removed by the Interim Order.”