DNA expert says Health Canada’s internal discussions contradict their public messaging about COVID-19 vaccine safety

Health Canada assures the public that the novel mRNA COVID-19 injection 'benefits continue to outweigh any potential risks,' yet internal emails highlight discrepancies between this public communication and private discussions.

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Genomics expert Kevin McKernan’s dissection of Pfizer’s mRNA COVID-19 vaccine vials sparked discussions among top regulators, including the US FDA, Europe’s EMA and Health Canada when he discovered the SV40 promoter in the shots.

This contaminant was undisclosed during authorization filings and regulatory disclosures, as acknowledged by Health Canada’s regulatory leader Dean Smith via emails obtained through access to information, and continues to raise concerns over potential health risks, like fertility impairment and adulteration claims.

Despite this, Health Canada repeatedly asserts that this previously undisclosed plasmid “has no functional role,” taking Pfizer’s word when they said that “the SV 40 promoter/enhancer poses minimal safety risk for human use.” Yet the promoter is traditionally used to create transfection. This process artificially introduces DNA or RNA into host cells, giving it the ability to modify host cells’ genetic content.

McKernan says that the most interesting thing about the Health Canada emails is the discrepancy between internal communication and what the agency is relaying to the public.

“We've seen them go on record saying the DNA is of too little concentration to matter,” he says, “yet [Health Canada is] asking Pfizer for their protocols to measure it. They asked for their protocols. So, which is it? Is it too low to matter or have you not measured it?”

“The other set of details in that email is they asked Pfizer to create a fragment length analysis assay, to which Pfizer responded by saying they don't currently have one, and they're going to have to develop it… Well, that's very different than what they've communicated publicly, which is that these fragments are all under 200 bases. So how do they know that if Pfizer themselves doesn't even have an assay to assess that? The internal communication with them and Pfizer differs from the [public] communication they're having. So they don't know the fragment lengths, we do.”

McKernan notes that he has developed a test to measure the fragments and says the levels substantially exceed World Health Organization Guidelines on DNA allowances.

In addition, Pfizer said that the SV40 plasmid is irrelevant and not needed for manufacturing, which McKernan says isn’t true.

He explains that the presence of kanamycin, an antibiotic, is crucial for SV40 to be able to replicate and dismissing the promoters significantly contradicts basic plasmid principles.

There is another claim by Health Canada that they are” not aware of any peer-reviewed scientific evidence that would raise safety concerns over the residual SV 40 regulatory elements present in the final vaccine product,” before they ask Pfizer to “please comment.”

McKernan says that this, too, is a factually incorrect claim.

“There is literature on SV40 binding the P53 gene from Drayman et al,” he details, “that shows that it binds to this tumour suppressor gene. And there are billions of copies of this SV40 promoter in every dose. So that to us is a major red flag. If you have any piece of DNA that binds a tumour suppressor gene, you have to stop and investigate: why is it in there?”

The P53 gene is described by McKernan as the guardian of the genome that actively stops the formation of tumours.

McKernan says these are entirely captured agencies that continue authorization of these novel products despite all of these concerns, taking Pfizer’s word at face value. This makes sense when consumers consider that Health Canada has shifted from being a tax-payer-funded entity to one primarily funded by the pharmaceutical industry in recent years.

While Health Canada requested Pfizer get rid of the DNA contaminants, despite asserting the non-functional and harmless role, the emails make it clear that there are significant discrepancies between Health Canada’s internal interactions and public comments.

The agency did not respond to a request for clarification.

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