A senior Health Canada official says pharma giant Pfizer made a conscious decision not to 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 Health Canada’s Vaccine Quality Division, wrote an email to a colleague at the FDA about SV40.
“I understand that there have been internal discussions at CBER [Center for Biologics Evaluation and Research] regarding the presents [sic] 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 contacted Health Canada on the matter on July 17, 2023. The first SV40-related email released in the department’s access-to-information package was sent two days later, on July 19.
In that email, Dr. Tong Wu of Health Canada’s Vaccine Quality Division reached out to his colleague Dr. Michael Wall, a senior biologist evaluator.
“Co [Pham, executive director of HC’s Centre for Vaccines, Clinical Trials and Biostatistics] agreed to have an IAS [possibly a reference to an Issue Analysis Summary to evaluate a new regulatory affair] for the SV40 promoter sequence as we discussed today. We can talk about it tomorrow,” Dr. Wu wrote.
‘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.Mr. McKernan also noted that Health Canada 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 order paper question tabled by Health Canada in the House of Commons in December appears to be in line with this observation.
“Yes, there was more than 10 ng/dose,” he wrote, referencing the threshold applied by Health Canada. “I am sure of it now.”
Even if the amount of DNA had been lower, concerns remain that the threshold was set for regular vaccines and not the new technology using lipid nano particles (LNP).
Seeking ‘Remedy’
In his Aug. 23 email to an FDA colleague, Dr. Smith said Health Canada did not view the SV40 issues as an “urgent risk topic,” although he expressed concerns about how the SV40 news could impact the upcoming fall 2023 vaccination campaign.“It would be unfortunate if the information circulating had a negatively [sic] impact on public acceptance of the vaccine this year or in the future,” he said.
Despite having that concern, Dr. Smith, the official responsible for evaluating the safety of vaccines, said regulating agencies should work to encourage Pfizer to “remedy the situation” before the campaign.
In the email, Dr. Smith said Health Canada believed the upcoming rollout of the fall COVID-19 vaccine campaign meant the agencies should be “on the same page.”
On Aug. 29, Health Canada senior biologist Dr. Wu wrote an email to Dr. Wall, the senior evaluator, saying he and Dr. Smith agreed they should not inform Pfizer of their interaction with the EMA and U.S. FDA on the SV40 promoter, “especially they [sic] do not seem to care much at this moment.”
Dr. Wu then added, “However, we can not say nothing! Please see the following text that Julie and I worked out.” He provided a draft comment to Pfizer’s response, which was blacked out in the access-to-information request.
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 previously stated 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 troubled by the revelations 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 were judged important enough to discuss 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 said. “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.”
