Why Health Canada's COVID vaccine approval for kids still raises red flags

A recent Order Paper question in the House of Commons revealed gaps in the data used to justify the COVID-19 vaccine authorization for children aged 17 and under.

Conservative MP Ted Falk raised the issue, questioning Health Canada’s decision to approve the modified RNA vaccine for children and asking about the risk-benefit analysis behind it. Falk specifically asked what serious adverse events (SAEs) Pfizer/BioNTech had disclosed before authorization, and whether Health Canada or other agencies had discovered new adverse events after approval.

Falk highlighted the case of Maddie de Garay, who was 12 when her mother enrolled her to partake in Pfizer’s Phase III clinical trial at Cincinnati Children’s Hospital in 2020. Maddie suffered severe symptoms after her second vaccine dose, including intense pain, cold extremities, and heart problems. She was later diagnosed with demyelinating polyneuropathy, but Pfizer reported her injury as “functional abdominal pain.”

Falk inquired whether this information had been properly disclosed and if Health Canada had added Maddie’s condition to their list of severe adverse events.

Health Canada’s lengthy response largely evaded these direct questions. The agency repeated its mantra that “the health and safety of Canadians is Health Canada’s top priority,” but did not address the specifics of Falk’s inquiry.

While the agency states that a “rigorous scientific review” is conducted before approving vaccines, it has been uncovered through exclusive documents that Health Canada’s review of Pfizer’s vaccine for children took less than a month, beginning on April 19 and concluding at authorization on May 5, 2021.

Moreover, the vaccine was only tested on roughly 1,000 trial participants who received the vaccine. Shockingly, only 58% of participants had two months of follow-up after their second dose, meaning the safety claims were based on approximately 580 children.

Health Canada’s response further ignored the issue of long-term safety, acknowledging that the risk-benefit profile of vaccines is assessed “throughout the lifecycle of vaccines,” implying that full risks cannot be known at the time of authorization. The agency dismissed Maddie’s case, stating, “The Government of Canada is not in a position to comment on cases relating to specific patients.”

The response also fails to consider the real risks of the mRNA technology, in light of inappropriately applied regulations, despite alarming evidence of excessive fragmented DNA contaminating vaccine vials.

Virologist Dr. David Speicher has warned that Health Canada has not sufficiently examined the potential for DNA integration and genetic tampering, particularly given the use of the SV40 promoter, which could lead to cancer, Alzheimer’s, and other long-term health issues.

These concerns are compounded by the fact that the novel RNA technology has never before been deployed at a population level on healthy individuals, making it impossible to accurately predict long-term effects in the absence of robust clinical trials.

Additionally, Health Canada’s initial reliance on “parental approval” for the novel injection authorization seriously undermines the credibility and reliability of the vaccine approval process. By prioritizing emotions over scientific data and empirical evidence, Health Canada authorized a product with no long-term safety testing, based on a “limited understanding of the virus.” This flies in the face of scientific integrity and has serious public safety risks.

Health Canada’s failure to address credible safety concerns and its admission of having no clear framework for determining an unfavourable risk-benefit ratio raises serious doubts about its transparency and the reliability of its decisions.

That is why the continued adherence to an outdated safety narrative, despite mounting evidence of risks, requires ongoing fact-finding, media scrutiny and a more cautious approach in the future.