A senior Health Canada official says pharma giant Pfizer made a conscious decision to not advise regulators that its mRNA COVID-19 vaccine contained a DNA sequence from the Simian Virus 40 (SV40).
This information appears among multiple emails between staff from key drug regulators, including Health Canada (HC), the U.S. Food and Drugs Administration (FDA), and the European Medicines Agency (EMA). The information was obtained through an access-to-information request.
On Aug. 23, 2023, Dr. Dean Smith, a senior scientific evaluator in HC’s Vaccine Quality Division, wrote an email to a colleague at the FDA about SV40.
Health Canada had obtained confirmation two weeks earlier from Pfizer that SV40 DNA sequences were present in its COVID-19 vaccine.
“I understand that there have been internal discussions at CBER regarding the presents of an SV40 enhancer/promoter sequence, noting that its presence is unrelated to the purpose of the Pfizer’s plasmid as a transcription template for their mRNA COVID-19 vaccine,” wrote Dr. Smith.
“Pfizer has communicated to us recently, that they apparently chose not to mention this information to EMA, FDA or HC at the time of their initial or subsequent submissions.”
Dr. Smith added the information had been independently made public in April 2023, via a pre-print study from U.S. scientist Kevin McKernan.
Mr. McKernan, a genomics expert, had found quantities of DNA in the mRNA shots above the regulatory threshold set out by the health agencies. Dr. Smith wrote that the study had resulted in “questions coming to agencies.”
The Epoch Times had contacted HC on the matter on July 17. The first email related to SV40 within Health Canada released in the access-to-information package was sent two days later, on July 19.
In that email, Dr. Tong Wu of HC’s Vaccine Quality Division reached out to his colleague Dr. Michael Wall, a senior biologist evaluator.
“Co agreed to have an IAS for the SV40 promoter sequence as we discussed today. We can talk about it tomorrow,” Dr. Wu wrote. “IAS” could be a reference to an Issue Analysis Summary to evaluate a new regulatory affair.
As first reported by The Epoch Times in October, Health Canada was not aware of the SV40 enhancer presence. Since then, the FDA and the EMA have both confirmed they also weren’t aware of its presence.
Health Canada has since maintained that the SV40 enhancer/promoter sequence is a “residual DNA fragment” in Pfizer-BioNTech COVID-19 vaccine. “The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators,” the agency has repeatedly said.****‘ZERO Checks’****This view has been challenged by Mr. McKernan and others, including Dr. Philip Buckhaults, professor of cancer genomics and director of the Cancer Genetics Lab at the University of South Carolina.
In response to the information released by Health Canada, Mr. McKernan posted a thread on the X platform. “No prior vaccine in Canada has been approved with such a sequence contaminant,” he said.
“Pfizer assured the sequence is not material to plasmid manufacturing,” he added. “This is an overt lie. You cannot make plasmids without the promoter for the antibiotic resistance gene. It is active in mammalian cells. If it’s not needed, why is it in there?”
Mr. McKernan also noted how HC has asked Pfizer for its Polymerase Chain Reaction (PRC) protocol, saying this means “they have performed ZERO checks on this DNA contamination themselves and are entirely relying on the word of the manufacturer.”
A response to a Canadian Member of Parliament’s question tabled in the House of Commons by Health Canada appears to be line with this observation. “It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies,” said Health Canada in December.
Concerns related to the presence of unintended DNA in the mRNA shots pertain to their potential to integrate into the human genome and cause issues like cancer. The Florida State Surgeon General Dr. Joseph A. Ladapo has called for a halt of mRNA shots over these risks.
Health Canada said in March in a document tabled in Parliament that “any claims that the presence of the SV40 promoter enhancer sequence is linked to an increased risk of cancer are unfounded.”
Dr. Buckhaults has started a scientific study to ascertain those integration risks. On April 23, he wrote on X that he had confirmed previous findings that the amount of DNA in mRNA shots exceeds the limit set by regulators.
“Yes, there was more than 10 ng/dose. I am sure of it now,” he wrote while posting his methodology. This is the same threshold applied by Health Canada.
Even if the amount of DNA was below, there are still concerns the threshold was set for regular vaccines and not the new technology using lipid nano particles (LNP).
Dr. Buckhaults wrote that the “10 ng limit is not appropriate for LNP encapsulated DNA,” adding that “as far as I know there have been no safety studies for this situation. It was not possible because of the abbreviated timeline during the emergency you saw authorization.”****Seeking ‘Remedy’****In his August 23 email to the FDA employee, Dr. Smith said HC Canada did not view the SV40 issues as an “urgent risk topic.” However, the official responsible for evaluating the safety of vaccines expressed concerns about how news of the SV40 could impact the upcoming fall 2023 vaccination campaign.
“It would be unfortunate if the information circulating had a negatively impact on public acceptance of the vaccine this year or in the future,” he said.
Despite being of this view, Dr. Smith said regulating agencies should work to encourage Pfizer to “remedy the situation” before the campaign.
In the email, Dr. Smith said HC believed the upcoming rollout of the fall COVID-19 vaccine campaign meant the agencies should be “on the same page.”
Mr. Smith’s email was written a day after Pfizer provided a response to a Quality Clarifax submitted by HC around the SV40 promoter. If deficiencies are identified in Clinical Trial Applications, HC may request additional information, which is known as a Clarifax.
On August 29, HC senior biologist Dr. Wall wrote an email to senior evaluator Dr. Tong Wu, where he said he and Mr. Smith agreed they should not inform Pfizer of their interaction with the EMA and U.S. FDA on the SV40 promoter, “especially they do not seem to care much at this moment.”
“However, we can not say nothing! Please see the following text that Julie and I worked out,” Mr. Wall added, before providing a draft comment to Pfizer’s response that was blacked out.
The same day, Dr. Wall also sent an email to Dr. Wu with a draft of the Clarifax questions to be sent to Pfizer, which included the statement, “Health Canada would continue to work with international regulatory partners to achieve ‘harmonisation regarding removal of these sequence elements from the plasmid for future strain changes.’”
Pfizer did not respond to a request for comment from The Epoch Times
Commenting on DNA contamination, Health Canada reiterated its previous position on the matter.
“Based on its evaluation of the data and scientific information for the vaccine, Health Canada has concluded that the risk/benefit profile continues to support the use of the Pfizer-BioNTech vaccine,” said spokesperson Anna Maddison.
Dr. David Speicher, a Canadian virologist who replicated the findings from Mr. McKernan and Dr. Buckhaults with Canadian mRNA vials, told The Epoch Times he’s preoccupied about what’s been revealed in the internal Health Canada emails. He notes that while Health Canada has dismissed the DNA fragments as biologically inactive with no functional role, they judged worthy to hold discussions with other regulators.
“We know from testing several vials that the level of SV40 enhancer-promoter in the XBB.1.5 booster is at similar levels as the others Pfizer COVID modRNA vaccines, making it just as problematic,” he says. “Pfizer has not cleaned up the vaccine, yet the regulators are sadly more concerned about vaccine uptake in the population rather than the health risks from these vaccines.”