All you really need to know is that when Australia’s Therapeutic Goods Administration (TGA) were required by Freedom of Information laws to release their testing protocol used to confirm to Australians that the Comirnaty injection had no residual DNA contamination, it looked like this:
Similarly, their release of the testing protocol for Moderna looked like this:
This is the modus operandi of Big Pharma who provide 96% of the TGA’s funding and offer a revolving door of career opportunities to “regulators” who approve and promote their products. Meanwhile the TGA claim, largely based on these heavily redacted documents, to have “debunked” the rigorous independent science taking place by individuals and teams with no conflicts of interest. These teams, from across the globe, have shown repeatedly that dangerous levels of DNA contamination are in the vials, and that same DNA contamination has been detected in biopsies of human tumour cells.
Geneticist Kevin McKernan presented on these findings at a conference in Massachusetts on 19 October 2024.
Investigative journalist Rebekah Barnett published an exhaustive piece in response to the TGA’s claims of “misinformation”. This response was compiled with the assistance of Kevin McKernan (CSO and Founder, Medicinal Genomics), Dr David Speicher (Virologist, University of Guelph), Julian Gillespie (Former barrister and advisor), Dr Ah Khan Syed (Arkmedic on Substack), Dr Jessica Rose (Immunologist and Computational Biologist, FLCCC Senior Fellow), Dr Robyn Cosford (Chair of Children’s Health Defense Australia), Dr Julie Sladden (Co-Director, Australians for Science and Freedom), and Dr Deirdre Little (GP Obstetrician).
The entire article is too long to share here, so below are the summary responses to each TGA claim. The full response is far more comprehensive than anything offered by the TGA, with zero redactions, showing that the TGA are by no means any “single source of truth”. The full article can be found at Addressing allegations that DNA contamination in the mRNA shots is ‘misinformation’.
1) Claim: “All COVID-19 vaccines approved in Australia have been rigorously assessed and meet our high standards for safety, quality, and efficacy.”
Rating: False.
Why: The Pfizer product administered to the majority of Australians was never tested in a randomised controlled trial (RCT), the TGA did not review patient level data, and key tests were not required by regulators for approvals.
2) Claim: The method of fluorometry is invalid because it overestimates DNA levels in the sample.
Rating: Misleading.
Why: Some of the labs that found excessive DNA contamination in the mod-RNA vaccines used qPCR, the TGA’s approved testing method. Several of the fluorometry tests used an enzyme called RNase A to eliminate the possibility of overestimation of DNA levels. Scientists argue that fluorometry is a more appropriate method for testing residual DNA than qPCR, which underestimates DNA levels.
3) Claim: The tests performed do not adhere to the TGA-approved guidelines.
Rating: Misleading.
Why: There is no compendial standard for measuring DNA in mod-RNA vaccines after it has been packaged in lipid nanoparticles (LNPs). The guidelines cited by the TGA do not account for the technological development of LNPs. Further, it states that alternative methods can be acceptable if there is a scientific justification.
4) Claim: “The physical reference materials were not adequately defined.”
Rating: Misleading.
Why: Key information is documented in the studies, such as tamper seal status, shelf life, and chain of custody.
5) Claim: Some studies only tested a small number of vials.
Rating: Misleading.
Why: Collectively, scientists have independently tested more batches than the TGA.
6) Claim: “The studies also used samples that were well past their use-by date. Some samples had already been opened and used. These samples were not suitable for testing.”
Rating: False.
Why: Excessive levels of the same DNA sequences were found in vials that were both in-code and expired, tamper sealed, and opened. The use-by for administration of the products to humans is irrelevant to the ‘use-by’ of residual DNA, which remains stable at room temperature for years.
7) Claim: The provenance of the samples is also not clear, so the TGA can’t know where they came from or how they have been handled.
Rating: Misleading.
Why: The TGA could easily have obtained chain of custody documentation as relates to the Australian report by contacting Speicher or replying to Ashby-Koppens’ email. Multiple analyses of the vials have documented chain of custody.
8) Claim: The accreditation status of the laboratories is unknown.
Rating: Misleading.
Why: The TGA has not contacted any of the scientists to request particulars of lab status. Unknown lab status is not a reason to ignore findings with potentially grave implications for the health and safety of millions of Australians. If the TGA finds the independent testing to be unsuitable, the TGA should publish the methods and results of its independent testing in approved labs for public review.
9) Claim: DNA is an approved starting material for many biotechnology products. Medicines produced by this technology have been used safely for over 40 years. Residual DNA is to be expected and is safe within the limits set by regulators.
Rating: Misleading.
Why: Therapeutics using mod-RNA packaged in LNPs are a novel development never used at scale in humans prior to the Covid vaccine rollout. Current regulations are for ‘naked’ residual DNA, not DNA carried into cells by LNPs. Residual DNA in any amount carried into cells by LNPs poses a safety risk. The Pfizer vaccine residual DNA contains a DNA sequence called the SV40 enhancer/promoter which poses a unique risk for genomic integration and cancer formation.
10) Every batch of mod-RNA Covid vaccines is compliant with the regulatory guidelines for residual DNA concentration.
Rating: Misleading.
Why: Independent testing of Australian vials found residual DNA in the mod-RNA vaccines at levels of seven to 145 times the allowable limit. Manufacturers are allowed to test their own products with methods that will underestimate the amount of DNA in the vials. The TGA has tested only a fraction of the total number of batches rolled out to Australians in the past three and a half years.
11) Claim: “To date, neither the TGA nor any international regulator has established a causal link between Covid vaccines and any type of cancer.”
Rating: Misleading.
Why: Neither the TGA nor any international regulator has looked for a causal link between Covid vaccines and any type of cancer.
12) Claim: There is no evidence of mRNA vaccines or biological medicines used in Australia resulting in integration of residual DNA into human DNA genome.
Rating: Misleading.
Why: The TGA has not looked for genomic integration. There is putative evidence of genomic integration of residual DNA in vaccines outside of Australia. There is also evidence pointing to the strong possibility of genomic integration, which should spur the TGA to look for it.
13) Claim: There were no adverse effects detected on male or female fertility, fetal deaths, birth defects, or developmental delays in the combined reproductive and development animal studies.
Rating: Misleading.
Why: These studies are not publicly accessible and so cannot be scrutinised. Documented reference to fetal harms was omitted from Pfizer’s Public Assessment Report without explanation, raising the question of whether this was an isolated incident, or not.
14) Claim: “Evidence from the more than 13 billion vaccine doses given worldwide shows that COVID-19 vaccines have a very good safety profile in all age groups. The benefits of the approved vaccines far outweigh the possible risks.”
Rating: False.
Why: This is one of those Big Lies that gets repeated ad nauseum in the face of all evidence to the contrary. Several points are discussed below but it is not worth wasting time, as this claim is tangential to the main issue of scientific findings of excessive DNA contamination in the mod-RNA vaccines.
CONCLUSION
In conclusion, we reject categorically the TGA’s claims that independent scientific evidence of excessive residual synthetic DNA in the mod-RNA vaccine is invalid, and that reporting on this science is “misinformation.”
The TGA should commission the necessary testing to provide evidence for its claims.
The TGA should also unredact all batch testing results to date, and make all relevant studies available for public scrutiny.
Finally, readers should consider the implications of the TGA’s use of the term “misinformation” in light of the Labor Government’s proposed legislation to combat online misinformation. A final version of the Combatting Misinformation and Disinformation Bill 2024 is due to be tabled in parliament later this year.
If passed, the legislation will require social media platforms to censor content that has been identified by authorities and accredited fact checkers to be ‘misinformation.’ This means that scientists will be unable to share their dissenting work and opinions online, and independent reporters will be unable to share their reporting on it.
The Aligned Council of Australia is running a campaign in opposition to the bill: find out more here.
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