Australian drug regulator knows DNA fragments in mRNA vaccines can enter nucleus and integrate into genome, internal emails show
The Therapeutic Goods Administration withheld information on DNA contamination risks from the public, presenting a picture of certainty where there is none
Internal emails from the Therapeutic Goods Administration (TGA) reveal that the regulator withheld knowledge of DNA contamination risks relating to the modRNA vaccines from the public, presenting a picture of certainty on safety where there is none.
Released under Freedom of Information (FOI), the cache of emails shows that high-level TGA staff knew elements of the modRNA vaccines can enter the cell nucleus and integrate into the genome, despite the agency’s official line that such events are not possible.
However, TGA personnel appear more preoccupied with “allaying fears in the public” than with investigating the potential risks.
Highlights
TGA staff acknowledge that DNA integration into the genome is possible
The TGA knows that the SV40 enhancer/promoter in the Pfizer vaccine can drag DNA into the nucleus of cells
Pfizer did not disclose the SV40 sequence to the regulator
TGA staff not aware of any testing for modRNA/DNA integration into human genome
On 18 October, the TGA published a statement, ‘Addressing misinformation about excessive DNA in the mRNA vaccines.’
The statement came after the release of a report by Canadian virologist Dr David Speicher alleging the presence of synthetic plasmid DNA fragments in Australian vials of modRNA Covid vaccines at levels of up to 145 times the regulatory limit.
The issue gained national media attention after a vote by the Council of mining town Port Hedland on 11 October calling for the immediate suspension of the vaccines pending an investigation into the DNA contamination, due to the potential risks of genomic integration, cancers, and other long-term health impacts.
The TGA’s statement was littered with false and misleading claims, which have been addressed in detail here. Now, emails released under FOI reveal that the TGA knowingly withheld information on DNA contamination risks from the public.
Involved in these communications were staff from the TGA’s Scientific Evaluation Branch (Toxicology and Biological Science Sections), Pharmacovigilance Branch, Communications team, and even TGA boss Professor Tony Lawler, showing that personnel at the highest levels are aware of the potential risks associated with synthetic plasmid DNA in the modRNA shots.
With thanks to
, whose request for all TGA correspondence related to the production of the webpage and associated social media posts regarding allegations of DNA contamination in modRNA vaccines has further exposed the regulator’s duplicity on this matter.Yes, foreign DNA can integrate into chromosomal DNA
The TGA has repeatedly stated that modRNA vaccine elements cannot enter the nucleus of cells, nor can they integrate into the genome.
Internal emails show that senior staff within the agency know this isn’t true.
On 14 October, a TGA staffer asks,
“Is it even biologically possible for residual DNA at a limit of no more than 10 ng/dose to retain enough integrity from dosing to entering a cell and being enough to be incorporated into a genome for it to induce the effects that are being speculated about?”
‘Yes, but unlikely,’ is the collective conclusion.
I cannot stress enough how contrary this is to official TGA and Department of Health messaging, which has vehemently denied that genomic integration of modRNA vaccine elements is possible at all.
Initially, one TGA staffer offers the argument touted by U.S. vaccine expert Dr Paul Offit and serially quoted by fact-checkers, including Scientific American, which is that foreign DNA in the modRNA vaccines cannot integrate with human DNA without the presence of an enzyme called integrase. As integrase is not present in mammalian cells, the argument goes, there is no integration risk.
However, TGA colleagues quickly debunk this claim, and it is deleted from the draft memo:
“Foreign DNA can integrate into chromosomal DNA in the absence of an integrase in mammalian cells. This comes from the DNA damage/repair literature where breaks in DNA are repaired through processes called non-homologous end joining or homologous recombination. Exogenous DNA can potentially be incorporated using these processes.”
From the Biological Science Section (BSS), “although unlikely, there are alternative mechanisms for DNA integration.”
And from a Senior Toxicologist,
“We agree with comments raised by BSS that the original dot point on the role of integrases should be deleted. There are papers implying that other enzymes/mechanisms are involved in integrating SARS-CoV-2 sequences into the DNA of human cells (see Zhang et al 2021).”
In the end, the assertion that DNA integration is not possible is dropped from the memo, replaced with a more nebulous statement about lack of evidence:
“There has been no evidence of mRNA vaccines or biological medicines resulting in integration of residual DNA into human DNA genome or causing cancer.”
However, one staffer admits that he or she does not know of any science to support this statement:
"With regard to adding the comment about plasmid DNA entering the human genome, I would be uncomfortable with that as I am unaware of studies which have tested this and so personally I have no experience in the matter."
The Senior Toxicologist suggests that the statement is too speculative and perhaps should be taken out:
“In the event that some aspects of the statement are too speculative, we can also omit the following sentence “There has been no evidence of mRNA vaccines or biological medicines resulting in integration of residual DNA into human DNA genome or causing cancer.””
However, the final TGA memo retains this sentence.
Under FOI request, the TGA could not provide evidence that it had examined any scientific findings related to testing for alteration of the human genome following modRNA vaccination.
‘SV40 enhancer region can promote nuclear transport of DNA’
As covered at length on this Substack, scientists say that the SV40 enhancer/promoter sequence present in the Pfizer modRNA Covid vaccine poses a unique risk for genomic integration and cancer because it is particularly effective at dragging material into the nucleus of cells.
The Health Minister Mark Butler’s official position on the SV40 enhancer/promoter is that,
“The TGA and the Department do not consider the presence of the SV40 promoter to be a safety concern. The SV40 promoter sequence is considered safe and is a common sequence used in biotechnology-based medicines.”
But privately, TGA staff say otherwise.
"The SV40 enhancer region can promote nuclear transport of DNA," writes a staffer in a comprehensive primer on the risks of residual DNA. This is known in the scientific community, but it is the first proof of acknowledgement from within the TGA.
The qualification follows, “Risk that this will happen is low due to low level of DNA. Risk if does happen, low as integration events have low probability.” Note that ‘low probability’ is a different thing to ‘not possible.’
There is no further discussion among TGA personnel about the implications of the SV40 enhancer/promoter dragging vaccine elements into the cell nucleus of vaccine recipients, which, as shown above, officials publicly insist cannot happen.
SV40 enhancer/promoter not disclosed to TGA by Pfizer
We already know that Pfizer did not annotate the SV40 enhancer/promoter on its DNA plasmid map submitted to regulators. In Health Canada emails released under an Access to Information and Privacy (ATIP) request, an official admitted,
“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.”
Now we have confirmation that Pfizer didn’t mention this gene therapy sequence to the TGA either.
From the emails,
“The plasmid for expression of the Pfizer mRNA was based on a pCMV-TAG vector (I used BLAST analysis of sequence from Mod3 as not all info was placed in the plasmid map provided by the Sponsor),”
and,
“The plasmid also contains a SV40 promoter and f1 ori region (not shown in plasmid map presented by Sponsor but found in BLAST and reported in Speicher & McKernan papers).”
Discussion of risks
Conspicuously absent from the internal TGA discussion of plasmid DNA risks is the difference between naked DNA and DNA encased in lipid nanoparticles (LNPs).
As detailed in my recent Substack article, ‘No evidence for TGA's mRNA safety claim,’ in traditional vaccines, residual DNA is ‘naked’ and can be expected to be mostly eliminated fairly quickly.
But in modRNA vaccines, LNPs travel to every major organ system in the body where they dump their contents into cells. Therefore, the DNA is not being destroyed before it makes it into cells.
In the case of the Pfizer vaccine, the presence of the SV40 enhancer/promoter increases the risk that this DNA, once in the cell, will be dragged into the nucleus.
The LNPs and the SV40 enhancer/promoter obviously change the risk calculation for residual DNA in modRNA vaccines.
However, while TGA staff indicate the need to address “misinformation” including the claim that, “The mRNA is different from recombinant proteins because the DNA is encapsulated in the LNPs,” at no point does anyone in the communication chain actually offer a scientific argument to refute this supposed misinformation.
Indeed, the only time the matter is directly addressed in over 200 pages of documentation is in a single paragraph:
“The TGA does not hold any evidence that the residual DNA is encapsulated in lipid nanoparticles. However, if it were, there is a low safety concern with the levels present as there is a sufficient safety margin.”
Previously, the TGA advised in email communications with me that, “There is no significance to minute amounts of residual DNA being encapsulated in the LNPs.”
It appears that the TGA is assuming that residual DNA, which was not successfully filtered out of the modRNA component before its packaging in LNPs, was somehow completely separated from the modRNA during the packaging process, with only modRNA being encased in the LNPs while the residual DNA just floats around naked in the rest of the vaccine mixture.
How the TGA could have arrived at such a fantastical conclusion is anyone’s guess, seeing as it was unable to provide any evidence for its stance on the insignificance of the LNPs when requested under FOI.
However, elsewhere, a TGA staffer does hint at the possibility that LNPs will contain residual DNA.
Likening the modRNA vaccines to “viral gene therapies” due to their use of high levels of DNA starting material, this person notes that, “They also have the potential to package non-target sequences and be administered to patients.”
In the risk assessment of the residual plasmid DNA provided by TGA personnel, oncogenic and genomic risks are acknowledged but determined to be highly unlikely. This breaks with official messaging which presents the picture of ‘no risk at all, ever.’
From the Senior Toxicologist,
“There are several published papers that describe an improbable risk of oncogenicity from integration of host cell DNA from biological products, but they are considerably old (e.g. Krause & Lewis, 1998; Yang et al., 2010).”
Indeed, both references are too old to have assessed the risks of modRNA vaccine plasmid DNA, including a nuclear-targeting SV40 enhancer/promoter, being deposited directly into cells in their LNP packaging.
Another TGA staff person, in the most comprehensive email on plasmid DNA risks, acknowledged that residual DNA can result in the inactivation of tumor-suppressor genes (leading to cancer formation), but only in high amounts.
Additionally, this staffer asserts that the smaller the DNA fragments, the lower the risk.
Once again, TGA staff seem to have forgotten that the scientific references they are referring to relate to naked DNA, not DNA packaged in LNPs and delivered straight into cells all over the body.
Note also the use of the word “contaminant” above to refer to the residual DNA, per the nomenclature of the referenced WHO Technical Report. This suggests that when the TGA says the Covid modRNA vaccines are “not contaminated,” the regulator is either playing semantics, or is not sufficiently familiar with the literature on the topic.
The risk assessment summary, as below:
Risk of expression of genes from residual DNA low due to fragmented nature of DNA
Risk of oncogene expression [RB note i.e.: cancer risk] is negligible
Risk of replication of DNA is negligible due to fragmented DNA (no intact plasmid) and lack of recognition of ori
Risk of insertion is extremely low based on levels and probability indicated in data
published by WHO, Yang etc. [still to get info re. direct injection into cells]
On the issue of DNA replication, the above mentioned email states that because the plasmid is of “bacterial origin,” this “ori” would not be recognised in human cells and so does not present a problem.
However, another staffer is less certain:
“Not sure if f1 ori not recognised. May be required for replication in mammalian cells (vector appears to be dual expression vector). Does it require other components? (just thoughts)”
Regardless, this person says, “the DNA is fragmented and this would be inconsequential.”
Scientists respond
“This is just overt smoke screening,” says Kevin McKernan, the genomics scientist who discovered the DNA contamination in the Covid modRNA vaccines.
McKernan, who is CSO and Founder of Medicinal Genomics, and who previously managed the R&D for the Human Genome Project at Whitehead Institute/MIT, set a few things straight in short order over email.
First, the TGA is “still not understanding the risk of LNPs and how these make the 10 ng [regulatory limit] irrelevant. All their citations are in reference to naked DNA.”
Second, the TGA is not up to date on peer-reviewed science showing DNA contamination in the modRNA vaccines over the regulatory limit (König & Kirchner 2024, and Kämmerer et al. 2024).
Third, on the assertion that smaller fragments of DNA result in lower risk, McKernan again emphasised that this is assumed for naked DNA, but not DNA wrapped in LNPs.
“When it’s naked DNA the smaller material will degrade faster. It’s not naked,” he explained. In fact, the risk increases when the DNA fragments are smaller but more plentiful.
“The smaller the DNA gets the lower the [safety] limit needs to be as the copy number goes up,” said McKernan, pointing to a peer-reviewed article by Sheng-Fowler et al. (2009) for the Food and Drug Administration (FDA) explaining exactly this.
Fourth, the chance that there is no residual DNA in the LNPs is zero. “The DNA is negatively charged and will be wrapped in LNPs for the same reason the RNA is. The cationic Lipids wrap themselves around negatively charged polymers,” said McKernan.
“Kämmerer et al. demonstrate that the DNA is in the LNPs as they find it in the cells post-transfection,” McKernan added.
Persistence of the residual DNA in human cells has also been documented informally by McKernan, and by genomics scientist Dr Phillip Buckhaults. And, most recently, plasmid DNA from the Covid vaccines was detected in blood samples from a South Australian study - this would not be possible if the residual DNA had been destroyed before making it into recipients’ cells.
Fifth, the plasmid is not just bacterial as claimed in the TGA emails, but has “mammalian origins of replication and viral elements,” McKernan clarified. This nullifies the assertion that the plasmid cannot replicate because of its apparent bacterial origin.
“The SV40 Ori is active in mammalian cells when coupled with an F1 Ori and ColE1. Both exist in the Pfizer sequence.” This is science-speak for ‘yes, this plasmid presents a replication risk in human cells.’
The regulations of 10 ng of residual DNA per vaccine dose “are now irrelevant as you can drive a truck through that regulation with LNPs containing DNA that has active mammalian origins of replication,” said McKernan in a Substack diving deeper into the ori issue.
Dr David Speicher, the virologist who detected excessive levels of DNA contamination in both Australian and Canadian vials of the modRNA vaccines, echoes McKernan’s concerns.
“They admit that integration [of synthetic plasmid DNA] is theoretically possible,” Dr Speicher said after reading the emails, noting the comment from one TGA staffer that the LNPs “have the potential to package non-target sequences and be administered to patients.”
Yet, “they are still applying the rules for naked DNA. While the plasmid may not have an integrase they rightly point out that ‘other mechanisms of DNA integration are possible.’”
Dr Speicher expressed alarm that these TGA emails from as recent October 2024 raise basic questions like whether the levels of residual DNA meet the quantity and size limits, whether there is any data on residual DNA being encapsulated in LNPs (or not), and seeking to confirm what SV40 sequences are contained in the Pfizer plasmid vector.
“They should have had those answers when Pfizer submitted for regulatory approval,” said Dr Speicher, emphasising that the Australian data alone answered these questions, showing:
The levels of residual DNA in the Covid modRNA vaccines are higher by both qPCR and fluorometry testing methods,
The residual DNA is encapsulated in the LNPs, and,
The presence of the SV40 enhancer/promoter.
“What strikes me is that their messaging is severe gaslighting and they are more concerned with maintaining the mantra of ‘safe and effective,’” said Dr Speicher.
Indeed, Dr Lisa Kerr, Assistant Secretary of the Laboratories Branch, who co-ordinated the internal communications to develop the TGA’s statement on DNA contamination ‘misinformation’ said as much.
“I’m primarily concerned with allaying fears in the public that this is actually something to worry about when it isn’t,” wrote Dr Kerr (she/her) in the thread discussing theoretical risks that have not been clinically investigated.
Dr Mel McCann, whose FOI request unearthed these emails, expressed dismay at what they reveal about the internal priorities of the TGA.
“Rather than contemplate the catastrophic consequence of DNA integration into the human genome or oncogenicity, the email trails focus on sanitising the public statement,” she said.
Dr McCann said she was not surprised, but felt the emails showed “disgraceful disregard for the risk to public.”
Of course Dr McCann should not be surprised, as lawyers representing the TGA recently argued for dismissal of the Covid vaccine injury class action she is leading on the basis that TGA officials (among others) did not owe a duty of care to Australian citizens who were injured by the medical products they approved and promoted.
Find out more about the Covid vaccine injury class action, representing over 2,000 injured Australians. If you have the means, you may consider making a donation.
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The TGA’s actions are beyond reprehensible—they are a catastrophic betrayal of the public they are sworn to protect. For years, the TGA has repeatedly and unequivocally denied the risks of DNA contamination in modRNA vaccines, insisting that genomic integration was "impossible." Yet internal emails now expose the truth: not only were they aware of the risk, but they also actively suppressed this information to maintain a narrative of "safe and effective." This is not just negligence—it is an intentional act of deceit and endangerment on a national scale.
The evidence is damning. TGA personnel acknowledged internally that DNA contamination could lead to genomic integration, posing serious risks such as cancer and permanent genetic damage. They knew about the presence of the SV40 enhancer/promoter—a genetic element capable of dragging foreign DNA into the nucleus of human cells—but instead of raising alarm, they chose to bury this fact. The TGA’s public stance, dismissing any possibility of harm, is not just misleading—it is an outright lie.
Their focus was not on investigating these dangers or protecting the public but on crafting statements to “allay fears.” This chilling prioritization of optics over lives reveals an agency entirely captured by corporate interests and political expediency. The TGA’s refusal to act, coupled with its active suppression of information, has placed millions at risk. How many Australians are now living with the consequences of genomic integration while the TGA denies, obfuscates, and gaslights?
Even more shocking is their continued insistence on the mantra of "safe and effective," despite mounting evidence of contamination and harm. The SV40 enhancer/promoter was not disclosed by Pfizer, and the TGA failed to demand accountability or even basic transparency. Instead, it perpetuated a deliberate cover-up, knowingly providing false assurances to the public. This is not just a regulatory failure—it is a willful act of harm and deception.
For the TGA to assert that there is "no risk" while knowing they had neither the evidence nor the scientific basis to make such a claim is criminal. Their own internal communications admit the lack of testing, the inability to refute contamination risks, and the scientific gaps in their assessments. Yet they continued to lie to the public, denying the very dangers they discussed privately. This is the behavior of an organization that has abandoned its mandate, its integrity, and its humanity.
Fantastic work Rebekah !!
Wow you're on a double hattrick vs the TGA, Rebekah! Great journalism and the reason my dollarydoos have paid for 2 years worth of subscription. Worth every cent to see the bastards kept to account like good journalism should!