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.
“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.
Moreover, the order made sure that the vaccine authorizations couldn't be revoked even under evidence that they were unsafe and ineffective. Once an interim order is issued, the typical Food and Drug Regulations don't apply.
The order thus exempted manufacturers from having to effectively demonstrate “objective evidence of safety and effectiveness” of their COVID-19 vaccines.
‘Not Safe for Human Use’The NCI report was supported by cardiologist Dr. Peter A. McCullough. “Excellent work @Inquiry_Canada with exhaustive testimony and evidence review. Conclusion: all COVID-19 vaccines unsafe for human use and must be removed from the Canadian market immediately to protect the public,” he wrote in a Sept. 16 post on X.
“COVID-19 vaccines and all of their progeny and future boosters are not safe for human use. I implore you, as a governing body, European Medicines Agency, to apply all pressure and due urgency to remove the COVID-19 vaccines from market,” Dr. McCullough said in Sept. 13 testimony to the European Parliament.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, a top FDA official, said in a statement.
“We all know there's a new vaccine that's coming around the corner, [a] new mRNA COVID-19 vaccine. And there's essentially no evidence for it,” he said during a press conference.
“There's been no clinical trial done in human beings showing that it benefits people, there's been no clinical trial showing that it is a safe product for people. And not only that, but then there are a lot of red flags.”
Not Actually ‘Interim’Canada’s interim order for COVID-19 vaccines “has become permanent,” according to the NCI report. An interim order typically only lasts for one year. In March 2022, the order was replaced with permanent regulations, which codified the “subjective authorization” of the vaccine.
“Thus, under the permanent test, Health Canada no longer has to be swayed by urgency, but simply by the public health need related to COVID-19. In this way, it seems that so long as COVID-19 is a circulating virus, Health Canada must authorize any vaccine for which there is an argument to support the conclusion that its benefits outweigh its risks,” the report states.
“In effect, we fear that there will never be a need for COVID-19 vaccine manufacturers to prove [the] safety or efficacy of their products.”
NCI also alleged there was a “conflict of interests” while approving the COVID-19 vaccines, with the government being involved.
Political Interests, Letter to TrudeauCanada usually doesn't allow drugs to be imported into the country unless approved by Health Canada. However, the interim order allowed the unapproved COVID-19 vaccines to be imported “as long as the Canadian Government was the purchaser,” according to the report.
This pre-purchasing and distribution of COVID-19 vaccines were done to make sure that they were available for dissemination as soon as they were authorized.
“This created a tremendous conflict of interest,” the report states.
“Once the vaccines were purchased, imported and ready for distribution, the Government of Canada would have suffered significant political blowback if it was unable to authorize them. Thus, it needed to authorize the COVID-19 vaccines, and it needed to do it quickly.
“The Government of Canada ordered the vaccines, imported them, created new regulations to authorize them, and then took significant measures to convince and coerce every Canadian to take multiple doses. The political stakes were high, and the federal government had every motivation to get the vaccines authorized, regardless of their actual efficacy or safety.”
“Canadians are relying on representations as to the safety and effectiveness of COVID-19 vaccines,” which Health Canada has never determined, the letter said. “Some might draw the conclusion that the misrepresentation to Canadians of proven safety is intentional, made while knowing it to be false and intending it to be relied upon.
“As a matter of common sense, the objective falsity of the ‘proven safe’ claim brings into question the basis for informed consent to the administration of the injections, creating potentially enormous liabilities.”
In the current context, the organization pointed out that the population immunity has increased along with the latest variants being “milder.”
“In the face of your government’s reported intention to promote booster injections in coming months, the urgency now lies in telling the truth to Canadians and taking corrective action,” the letter reads.
The NCI asked the prime minister to withdraw COVID-19 vaccines “until the normal rigorous evaluation can be completed” and to reinstate the traditional objective test for safety.