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Originally published on The Defender.
In what one scientist described as an “admission of epic proportions,” Health Canada on Thursday confirmed the presence of DNA contamination in Pfizer COVID-19 vaccines, and also confirmed that Pfizer did not disclose the contamination to the public health authority.
The DNA contamination includes the Simian Virus 40 (SV40) promoter and enhancer Pfizer did not previously disclose and that some experts say is a cancer risk due to potential integration with the human genome.
Health Canada, the country’s public health authority, told The Epoch Times that while Pfizer provided the full DNA sequences of the plasmid in its vaccine at the time of the initial submission, the vaccine maker “did not specifically identify the SV40 sequence.”
“Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid (such as an SV40 enhancer) at the time of submission,” it said.
Health Canada’s admission came after two scientists, Kevin McKernan and Phillip J. Buckhaults, Ph.D., discovered the presence of bacterial plasmid DNA in the mRNA COVID-19 vaccines at levels potentially 18-70 times higher than the limits set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency.
They tested four expired Pfizer and Moderna vaccine vials “thought to only contain mRNA” and found to contain “double-stranded DNA plasmids.”
Health Canada said, “We have concluded that the risk/benefit profile continues to support the use of the Pfizer-BioNTech vaccine,” and that it does rely on manufacturer claims but “conducts an in-depth independent review” to make sure the vaccines meet “our high standards for safety, efficacy and quality.”
Janci Lindsay, Ph.D., director of toxicology and molecular biology for Toxicology Support Services, told The Defender this statement is “silly, not believable and not defendable,” adding that “We should not have to do the research that they should have done.”
“Why are the FDA, CDC [Centers for Disease Control and Prevention] and the mainstream media still silent about this?” asked Steve Kirsch, founder of the Vaccine Safety Research Foundation, adding that “the mainstream medical community is silent as well.”
Bridle also wrote:
“One must wonder why Pfizer would not disclose the presence of a biologically functional DNA sequence to a health regulator. Pfizer was required to disclose to health regulatory agencies all of the bioactive sequences in the bacterial plasmid DNA that they used to manufacture their shots.”
The contamination “would have been discovered sooner by independent researchers, but people were threatened with arrest if they supplied vials for analysis,” Kirsch said, claiming he faced threats if he “participated in trying to analyze the vials.”
Bridle noted that it’s been “818 total days” since the University of Guelph banned him from accessing his office and laboratory for attempting to conduct similar research, while other researchers “have been the focus of attacks from many so-called ‘misinformation experts,’” even though none “have been able to refute their findings.”
Plasmid DNA contamination ‘an ongoing problem’
Immunologist, biologist and biochemist Jessica Rose, Ph.D., told The Defender, “Residual DNA has been found in the Pfizer and Moderna — and more so Pfizer — products, in older and newer vials, including the adult monovalent XBB.1.5 [vaccine].”
Rose said this indicates such contamination “is an ongoing problem.”
In separate remarks made Wednesday on CHD.TV’s “Good Morning CHD,” Rose said that McKernan “even looked at the Janssen [Johnson & Johnson vaccine] and discovered residual DNA at very high levels.”
Rose said Buckhaults initially “set out to prove [McKernan] wrong” but instead ended up replicating his findings.
“Plasmid DNA is used in the manufacturing of mRNA vaccines and is supposed to be removed to a level below a threshold set by health regulatory agencies before the final product is released for distribution,” The Epoch Times reported.
McKernan’s discovery made it “possible for Health Canada to confirm the presence of the enhancer based on the plasmid DNA sequence submitted by Pfizer against the published SV40 enhancer sequence,” Health Canada said.
Health Canada’s revelation came on the same day a new preprint study by Kernan, Rose and others provided more evidence of COVID-19 vaccine contamination in vials from Ontario, Canada.
The paper also presented evidence that Pfizer vaccines used during clinical trials differed from those made available to and administered to the public.
SV40 can ‘potentially integrate into the human genome’ — ‘forever’
SV40 is frequently used in gene therapy for its unique ability to deliver genes to targeted cells.
In the vaccine manufacturing process, SV40 “is used as an enhancer to drive gene transcription,” The Epoch Times wrote. McKernan last month “warned that the presence of DNA plasmids in the vaccines mean[s] they could potentially integrate into the human genome.”
Describing McKernan’s research as “unimpeachable,” Kirsch wrote on his Substack, “DNA lasts forever, and if it integrates into your genome, you will produce its product forever.”
Christof Plothe, D.O., a member of the World Council for Health’s steering committee, told The Defender the presence of SV40 is “problematic in terms of unwanted immunological reactions and potential integration into the genome, with resulting DNA damage and alteration ability, which can lead to cancer” and “many side effects.”
“This should not be in the vials, as they pose the risk of integrating their genetic information into cells of our microbiome or any cell of our body,” Plothe said.
“This can result in the newly programmed cell reproducing and producing mRNA with the resulting spike proteins for an unknown time, potentially forever and even to the next generation.”
Charlene Bollinger, founder of The Truth About Vaccines and The Truth About Cancer said, “My question is not only why did Pfizer hide the COVID-19 vaccine ingredient list, but also, was the Pfizer COVID-19 shot designed to create ‘turbo cancers’?”
“We have been warning about the harm these vaccines have been causing,” she told The Defender. “Sadly, it seems we were quite accurate all along.”
Patrick Provost, Ph.D., professor of microbiology and immunology at Laval University in Canada, told The Epoch Times “All it takes is a single integration [of SV40] at the wrong place in a single cell to initiate a cancerous process and kill a person.”
SV40: ‘all risk, no reward’
McKernan told The Epoch Times that because Pfizer’s vaccines already contain the same type of promoter as the one used in Moderna’s vaccine, the inclusion of the SV40 promoter was “completely redundant” and “all risk, no reward.”
Lindsay confirmed this in remarks shared with The Defender, adding that the DNA plasmids are nevertheless harmful even without SV40 present.
“It’s very important to note that SV40 elements are not needed for the plasmids to be a problem, as they can integrate without SV40 because of special proteins inside the cell, if they get into the cell that will carry them into the nucleus, where they can then integrate into the genome. The SV40 sequences are just an extra boost,” she said.
Lindsay said that multiple sequences of SV40 were identified, including “the SV40 origin of replication, the SV40 promoter and the SV40 enhancer, which contains a nuclear targeting sequence which takes the DNA payload straight to the nucleus.”
Lindsay questioned why Health Canada did not address the presence of the other two SV40 sequences. “What about the other two sequences? No mention of them?” she said. “Every other scientist has found them. [Is Health Canada] trying to downplay this?”
Contamination can lead to cancer, anaphylaxis and other severe reactions
According to Bridle, some potential problems involving DNA contamination include that it can be very long-lasting, has the potential to be incorporated into a person’s chromosomes and can cause inflammation.
Rose told The Defender the contamination “is problematic in terms of unwanted immunological reactions and potential integration, DNA damage and alteration ability.” “This is why we clean it, and lipopolysaccharides, out at the end of the modRNA synthesis workflow that utilizes the plasmid/E. coli system for DNA upscaling.”
Speaking to CHD.TV Wednesday, Rose provided a further explanation, saying that “a plasmid E. coli system” was used to produce “tons of DNA, which is really good when you need to upscale a product,” and which was present in the Pfizer and Moderna COVID-19 vaccines made available to the public — but not those used in clinical trials.
“The problem was that at the end of the synthesis process of the modified mRNA, apparently the residual DNA from the plasmids that were used to make this modified mRNA was not cleaned out properly,” she told CHD.TV. “We’re not supposed to have any relatively high levels of DNA at the end of the purification process.”
This may have contributed to the high rate of adverse reactions, Rose said. “This is an endotoxin. … if you inject endotoxin into a person as part of a product, you can kill them. What usually happens is they get anaphylaxis. One of the adverse events that we’ve heard a lot of reporting on is anaphylaxis,” a severe allergic reaction, she said.
“Endotoxin injection would induce anaphylaxis and/or sepsis, and there are tens of thousands of reports of these adverse events in VAERS [Vaccine Adverse Event Reporting System] … not considering underreporting,” Rose added, saying “This could also be why we’re seeing a lot of cancer,” though direct evidence of this is still lacking.
VAERS has historically been shown to report only 1% of actual vaccine adverse events.
In a recent article, Dr. Angus Dalgleish, professor of oncology at St. George’s Hospital Medical School in London, said he has observed an increased incidence of cancer after COVID-19 vaccination, including an “epidemic of explosive cancers,” observing possible “DNA plasmid and SV40 integration in promoting cancer development.”
Similarly, John Beaudoin Sr., author of the forthcoming book, “The Real CdC — COVID Facts for Regular People,” told The Defender “Deaths involving secondary malignant cancers of lymph nodes are more than four times normal rates in 2023.”
Buckhaults, however, attempted to downplay the cancer risk, noting that he was skeptical about the connection between “turbo cancers” and the COVID-19 vaccines. Separately, he wrote that SV40 is a “standard bit of molecular biology engineering” that has been “used for decades.” However, he acknowledged it poses a “non-zero future cancer risk.”
Mark Johnson, a spokesperson for Health Canada, told The Epoch Times that current data do not show a connection between the vaccines and “turbo cancers.”
Lindsay took issue with this statement, telling The Defender that “several oncologists have come out to speak on this,” noting that “we have seen an increase in the ICD codes that code for cancers” and adding that “there are all kinds of reports of fast-acting cancers taking people out within days to months of diagnosis.”
McKernan told The Epoch Times there is another cause for concern relating to the presence of SV40 in the COVID-19 vaccines — namely, the association of SV40 with polio vaccines,” which he said may be the reason Pfizer didn’t disclose its presence.
SV40, “an oncogenic DNA virus, was previously removed from polio vaccines due to concerns about a link to cancers … as the virus was present in monkey kidney cells that were used to grow the vaccine,” The Epoch Times reported.
“We don’t fully know the ramifications of the contamination, but they probably aren’t good, and they could be devastating and irreversible. We don’t know yet because nobody has done the necessary studies,” Kirsch wrote.
Preprint study highlights undisclosed manufacturing change for public vaccines
The findings confirmed by Health Canada were further borne out in the preprint study where Rose, McKernan and several other scientists address the two different processes used to produce Pfizer’s clinical trial vaccine and the version later distributed to the public.
“Production of modRNA used in the original Pfizer randomized clinical trial … utilized a PCR-generated DNA template (Process 1). To generate billions of vaccine doses, this DNA was cloned into a bacterial plasmid vector for amplification in Escherichia coli before linearization (Process 2),” the study notes.
As a result, this expanded “the size and complexity of potential residual DNA” in Process 2 — the vaccines administered to the public — and introduced “sequences not present in the Process 1 template.”
“These data demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines,” the study further states, noting that the levels of DNA contaminants exceed thresholds set by the FDA and World Health Organization.
Speaking to CHD.TV Wednesday, Joshua Guetzkow, Ph.D., senior lecturer at the Hebrew University’s Faculty of Law in Jerusalem, said Pfizer performed a “classic bait-and-switch” with the COVID-19 vaccine.
“The first ones were made with PCR,” Guetzkow said, “which basically just replicates ant DNA sequence that you give it,” whereas process 2 used E. coli, which he said is “generally not good for us,” but to which the plasmid DNA template was added and then grown “by replicating the bacteria.”
“They cut it up, they lay it out and then they make mRNA with it,” he said. “Then they have to clean all that stuff out … Not only did they not do a good job at it, but it’s really unclear how well they would be able to … get it out if they really tried.” He added that “the methods they use to measure how much endotoxin there is are very unreliable.”
Text revealing Pfizer’s two different “processes” was buried on page 360 of a 1,413-page document, marked “confidential” and dated Oct. 29, 2020, amending the research protocol for the company’s then-candidate COVID-19 vaccines. It was made public in 2022 as part of the court-ordered release of the “Pfizer documents.”
“The scale of the BNT162b2 manufacturing has been increased to support future supply. BNT162b2 [which was later approved] generated using the manufacturing process supporting an increased supply (‘Process 2’),” the document states.
According to Bridle, the results of the preprint “are profound,” noting that it “generated the largest data set to date on this topic, using vials from multiple Canadian batches of both the Pfizer and Moderna shots,” finding that all were “contaminated with bacterial DNA” and confirming the presence of SV40 in all Pfizer vials tested.
Rose said, “DNA was found in all 27 Pfizer and Moderna vials” tested and that, as part of the study, the researchers involved “were able to commence a dose response curve using serious adverse event reports for the specific vials tested,” using VAERS data.
According to the study, “A positive dose response relationship was observed for the Pfizer lots based on qPCR estimation of residual DNA,” although Rose told The Defender, “We need more data points, which means we need more vials tested.”
“Efficacy and safety demonstrated using clinical batches manufactured using ‘Process 1’ are also applicable to commercial batches produced using ‘process 2,’” Health Canada said, according to The Epoch Times.
McKernan told The Epoch Times that Health Canada’s response was a “trust me” answer, and questioned why the results showing the double-stranded DNA contamination were hidden.
Guetzkow said the method regulators used to test the “process 2” vaccines “missed small pieces of DNA,” though “most of the DNA [in the vaccines] is in small sequences.”
“Small pieces of DNA increase the risk of integration,” Lindsay said, while Rose said Moderna “cleaned out their DNA better, but it is also possible that they simply created more smaller bits of DNA.”
“The point here is there’s no possibility of informed consent here,” Rose told CHD.TV.
“This is a different product that went in [people’s bodies]. It’s absolutely something that should have had its own clinical trial because it was so different.”
PREP Act’s liability shield showing cracks as court actions mount
The liability shield enjoyed in the U.S. by vaccine manufacturers under the Public Readiness and Emergency Preparedness (PREP) Act may also be called into question as a result of the revelations regarding contamination of the COVID-19 vaccines.
Ray Flores, senior legal counsel to Children’s Health Defense, told The Defender that “Until now, it’s been the Wild West when government officials and manufacturers assume the PREP Act permits them to operate under the assumption that anything goes.”
“Although courts have routinely barred battery and negligence claims, it remains to be seen whether courts will find in favor of a defendant who has engaged in fraud,” he said.
“With concrete evidence of fraud, shareholder derivative suits, that have so far been unsuccessful, could finally win,” Flores said, noting that Pfizer’s stock is down over 39% this year. “The courts and public may not be so forgiving this time,” he added.
Bridle referenced a recent Michigan court ruling finding that the PREP Act does not apply to remdesivir, a COVID-19 treatment administered under Emergency Use Authorization, on the basis of “negligent manufacture” of the product.
“The court ruled that a pharmaceutical company’s legal indemnity was null and void for a contaminated version of the medical product,” Bridle wrote. “So, it would follow that Pfizer’s legal indemnity should be null and void for shots that contaminated with bacterial DNA that … was not disclosed to regulatory agencies.”
Rose said that in confirming COVID-19 vaccine anticipation, Health Canada may be anticipating future lawsuits and angling for less severe legal penalties.
“It is likely an admission for pre-emptive lesser conviction when this milieu turns to lawsuits,” she said. “I believe admission is, and has been, the only thing that any regulator can do at this point to not only save Canadians, but themselves.”
The World Council for Health and the Association of American Physicians and Surgeons are now both calling for the COVID-19 shots to be recalled, a view shared by German-Thai microbiologist Dr. Sucharit Bhakdi, who told The Defender “all mRNA injections must be stopped worldwide and forbidden until the major issues have been resolved.”
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