No evidence for TGA's mRNA safety claim
Australia's drug regulator claims that LNPs carrying synthetic DNA into cells all over the body are safe, but refused to provide proof under a Freedom of Information request
Australia’s drug regulator has repeatedly stated that residual synthetic DNA in mRNA vaccines poses no risk, despite credible concerns for long-term health consequences, including the risk of cancer and genomic integration.
However, after months of stalling in response to my Freedom of Information (FOI) request for the evidence underpinning key safety claims related to the DNA issue, the Therapeutic Goods Administration (TGA) has produced … nothing.
This leaves open the question of how the TGA knows these products are safe if it can’t produce supporting evidence.
‘Serious regulatory oversight’
International regulatory guidelines allow up to 10 nanograms of synthetic DNA per dose of vaccine, a byproduct of the vaccine manufacturing process that is supposed to be filtered out of the end product.
However, some scientists, particularly those with expertise in cancer and genomics, contend that the application of this DNA limit, which was created for traditional vaccines, to the new mod-RNA vaccines is a “serious regulatory oversight.”
That’s because in traditional vaccines, the DNA is ‘naked,’ and so will mostly get chewed up by the body pretty quickly.
But the DNA in mod-RNA vaccines is not naked - it is packaged in lipid nanoparticles (LNPs), which travel to every major organ system in the body where they then dump their contents into cells.
Whatsmore, the DNA in the Pfizer/BioNTech mod-RNA Covid vaccine includes a sequence called the SV40 enhancer/promoter which is shown to be an effective gene therapy tool for dragging material into the cell nucleus - something that regulators have said cannot happen with the mod-RNA vaccines.
This oversight has been highlighted most recently in a new peer-reviewed paper by German scientists, Kämmerer et al., which states,
“Of note, official limit values for residual DNA in biologicals are defined for antibodies, attenuated vaccines and protein solutions, but not for RNA injections and - even more important - for nucleic acids packaged in transfection reagents like lipid nanoparticles, which were used for the first time in the COVID-19 injections. In fact, no scientific evidence exists that would permit a safety level of residual DNA to be defined in such injectables whatsoever.”
The authors add that the presence of the SV40 enhancer/promoter in the Pfizer/BioNTech residual DNA is “highly dangerous” and “worrying.”
What are the implications of synthetic DNA - in Pfizer’s case, with a sequence that’s really good at getting into the nucleus of cells - being deposited into vaccine recipients’ cells by the LNPs?
Experts in the field say that the potential risks are cancers, genomic integration, and other health impacts such as cardiac events or auto-immune responses, and have called a complete halt to the mod-RNA vaccines while further investigation is carried out.
While it’s early days, scientific evidence that genomic integration is theoretically possible has been published in the peer-reviewed literature, and findings suggestive of genomic integration in human tissues have been informally published, as work in this space continues.
Kämmerer et al. found that the residual synthetic DNA fragments in BioNTech lots were “shown to enter and persist in cells,” results which authors said “confirm and extend published reports and raise grave concerns regarding the safety of the BNT162b2 [BioNTech] vaccine.”
But the regulator disagrees.
“There is no significance to minute amounts of residual DNA being encapsulated in the LNPs,” a TGA spokesperson told me emphatically earlier this year.
As the TGA had never provided evidence for this claim in prior media communications with me, and as I could find no evidence in the public record to support the claim, I FOI-ed the TGA to find out what scientific information it was holding that informed this important safety claim.
My FOI request, submitted on 26 July 2024:
“The document showing evidence of the TGA's claim in your email communication to me dated 20 June 2024: ‘There is no significance to minute amounts of residual DNA being encapsulated in the LNPs’.
”This should include evidence of any in-situ hybridisation experiments conducted by the TGA, and/or genotoxicity assessments and/or long-term carcinogenicity data and/or an expert panel committee meeting minutes which identify the experts that have contributed to this statement.”
In the same FOI, I requested documents showing the scientific evidence for another claim made by the TGA in our earlier communications, that “there is no accepted science that shows any alteration of the human genome.”
What ensued was four months of obfuscation and misdirection, where, with lengthy delays between communications, the TGA insisted that this information was already publicly available, but refused to link to where it could be found.
First, the TGA declined to provide any documents on the basis that, “much of the information you have requested can be found within publicly available resources and therefore does not have to be reproduced in an FOI request.”
The TGA suggested links to the Senate Estimates Questions on Notice (QoN) database, World Health Organisation guidelines, and the TGA FOI disclosure log, all of which are vast databases that are not easily searchable.
I asked the TGA to specify which information it was referring to by providing links directly to the pages that contained the requested documents.
Two weeks later, the TGA responded suggesting another database to search, this time for Senate Estimates transcripts. An additional suggested search term for the QoN database turned up zero results.
I replied saying that as database searches had not yielded the documents I was seeking (hence my FOI request), please could the TGA provide a direct link to the specific documents it was referring to, ideally with document names and dates.
A week later, the TGA advised that my request had been forwarded to the Laboratories Branch “for input.” This should not have been necessary, as my request was simply for the documentation relied upon for policy development, which the TGA had already advised was publicly available.
After another week’s wait, I received an email with a link to the TGA’s media statement accusing online reporters sharing scientific findings of excessive DNA contamination in the mod-RNA shots of spreading “misinformation.”
As this October statement was released four months after the TGA made its claims in communication with me in June, it could not have been relied upon as evidence for the claims made in June. Moreover, the statement contained no citations/evidence for the TGA’s claim about LNPs or genomic integration.
I replied noting that I had been sent a PR statement, not scientific evidence, as requested in my FOI. “I'm not sure how I can be more clear in making my request, which should be very straightforward,” I wrote, before reiterating my request and providing my phone number in case anyone at the TGA needed to seek clarification.
After receiving no response, I followed up a week later, and was again advised that my most recent email had also been sent to the Laboratories Branch for “further input.” The TGA spokesperson also attached one Senate QoN document which confirmed that the TGA did not require testing for genotoxicity before approving the mod-RNA vaccines, and which ignored findings of reverse-transcription of mod-RNA into DNA based on a commentary article cautioning that lab dish findings are not generalisable to entire populations.
This information is already publicly available - I reported on it back in August 2023. More importantly though, this document contained no scientific evidence to support the TGA’s claim that there is no significance to residual DNA being encapsulated in LNPs. Nor did it contain any evidence falsifying the findings of the paper discussed in the QoN.
By now, it’s early November. I replied raising the above points, reiterating my request, and highlighting that my FOI request was now months overdue (30 days is the statutory period for receiving the requested documents).
Mid-November, the TGA finally responded to close the case. The spokesperson misrepresented my request for documents as “questions,” which the FOI department is not required to respond to (they provide documents only) to get around the awkwardness of having to admit that the TGA holds no documents showing evidence for its sweeping safety claims.
The final email from the TGA (shortened for relevance), sent on 15 November:
“The decision maker for your request… has advised that there are no further documents or advice they can provide, further to what has already been provided to you as part of your decision. As you were provided with a decision notice on 19 September, and documents relevant to that request, this request is now considered finalised.
“As previously communicated to you, FOI is a process for seeking access to documents held by an agency, rather than an avenue for seeking answers to questions.
“The TGA has given extensive evidence at Senate Estimates on the quality, safety and efficacy of the mRNA vaccines, and has published a media statement on recent misinformation circulating about these products (www.tga.gov.au/news/media-releases/addressing-misinformation-about-excessive-dna-mrna-vaccines). You should not limit your search of the Senate Estimates information to just one response. The TGA has answered over 200 questions on the COVID-19 vaccines since 2020. Please also see ICMRA statement on the safety of COVID-19 vaccines | Therapeutic Goods Administration (TGA).”
To recap:
a) The TGA insists the documents I requested are publicly available;
b) But the TGA refuses to point to where this information is publicly available;
c) The TGA made several attempts at misdirection by sending irrelevant information such as a PR statement and QoN that were not relevant to my FOI request;
d) When I highlighted this, the TGA mischaracterised my reiterations of my original FOI requests as “questions,” which do not have to be answered under the FOI Act;
e) In sum, the TGA did not provide any documented scientific evidence for its claims, or meeting minutes in which scientific evidence was discussed in order to formulate its claims; and,
f) At the same time, the TGA expertly avoided admitting that it does not hold any evidence for its claims.
I have now opened the matter with the Office of the Australian Information Commissioner, requesting that the OAIC force the TGA to either hand over the documents, to show where they are in the public domain, or to state in clear terms if they do not exist.
The TGA’s unwillingness to provide evidence for its mod-RNA safety claims is shocking, but not surprising. The regulator has a history of obfuscatory tactics when it comes to public accountability, preferring the ‘trust me bro’ approach over rigorous transparency.
From hiding children’s post-vaccination deaths, to guaranteeing Covid vaccine safety despite having no idea how many adverse events the products have caused, to allowing AstraZeneca to retain provisional approval for Vaxzevria after it caused 13 confirmed deaths of Australians, to smearing scientists and reporters rather than refuting their findings with evidence, to redactions, redactions, and outright blocking FOI requests, to arguing in court that TGA officials owe no duty of care to Australians injured by the products they approved - don’t you just trust the TGA?
Such determined bureaucratic obfuscation is especially concerning given the novel aspects of the mod-RNA platform, which had never been approved for mass administration to humans prior to the Covid pandemic.
Meanwhile, mod-RNA research and manufacturing is ramping up in Australia, with the recent opening of a new Moderna facility at Monash University in partnership with the Federal and Victorian Governments - just one of many mod-RNA facilities rolling out around the country.
With Australian federal and state governments making themselves major stakeholders in these mod-RNA partnerships with academia and industry, the margin for conflicts of interest widens.
And the regulator of this whole shebang can’t, or won’t produce the scientific evidence to prove that any of this is safe.
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The writing is on the wall for the TGA.
If, big if, if they threw in the towel and admitted these injections were as bad as they were, I imagine more flack would be directed at Authorities and Authoritarians who implemented insane covid policies.
It is deeply troubling and profoundly disappointing to witness the TGA's lack of transparency and accountability regarding the safety claims of mod-RNA vaccines. The refusal to provide evidence under a Freedom of Information request casts a shadow of doubt over the agency's commitment to public health. When a regulator tasked with safeguarding the population cannot substantiate its claims about the safety of residual synthetic DNA encapsulated in lipid nanoparticles (LNPs), the question arises: whom does the TGA truly serve?
The implications of synthetic DNA carried by LNPs reaching every major organ system, as described in the work of Kämmerer et al., should be met with rigorous scientific investigation, not dismissive public relations statements. The absence of credible evidence to counter concerns about potential risks, such as genomic integration, cancer, and auto-immune responses, reflects a regulatory oversight that borders on negligence.
What amplifies the dismay is the TGA's bureaucratic obfuscation, highlighted in this account of FOI delays, misdirection, and refusal to engage meaningfully. This behavior not only undermines trust in the institution but also erodes the public's confidence in Australia's broader health regulatory framework.
The push for mod-RNA manufacturing partnerships with academia and industry raises serious questions about conflicts of interest. While the development of cutting-edge biomedical technology is commendable, it must not come at the expense of transparency, independent oversight, and, most importantly, public safety.
Australians deserve a regulator that prioritizes the health and well-being of its citizens above corporate or political interests. The lack of evidence for safety claims is shocking and unacceptable. It is imperative that the TGA provides clear and documented proof to back its assurances or admits that the evidence does not exist. Anything less is a disservice to the people it is meant to protect.