COVID-19 vaccines were authorized in Canada during 2020 and 2021 without being subjected to the country’s safety tests as required under established drug regulations, an accountability watchdog revealed.
An investigation into COVID-19 vaccines found that they were “neither safe nor effective,” according to the nonprofit organization National Citizens Inquiry (NCI). The organization published a report on Sept. 14 detailing the flawed mechanism through which the vaccines were granted “approval” in Canada.
“It is important to understand that the COVID-19 vaccines were never approved under the traditional approval process for drugs in Canada,” the report states (pdf). Instead, Health Canada, the federal agency responsible for national health policy, approved the vaccines through an alternative authorization process—an interim order.
“Under the alternative authorization process, the necessity to establish the safety and efficacy of COVID-19 vaccines through an objective manner appears to have been set aside,” the report states.
Canada’s Food and Drug Regulations require that a drug can only be approved in the country after its safety and effectiveness are demonstrated to the minister of health. Then, the minister considers whether the benefits outweigh the risks, following which, approval is granted.
Instead of following regulations, the minister of health sanctioned an interim order on Sept. 16, 2021, which exempted all COVID-19 vaccines from normal review and approval. This provision usually allows the minister to override normal regulations in situations of “significant risk” to health, safety, or the environment.
In Canada, four COVID-19 vaccines were authorized by the health agency under an interim order—Pfizer-BioNTech, Moderna, Janssen, and AstraZeneca.
The report notes that under the order, vaccines were authorized under a “subjective test.” In this situation, authorization is granted by simply proving that the benefits of vaccination outweigh the risks.
“This cannot be an appropriate standard for approving a drug that the Government intends to administer to the entire population. It is difficult to conceive of a less-scientific test for drug authorization than that found in the Interim Order,” the report states.
