The Vax-Gene Files: Have the Regulators Approved a Trojan Horse?

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The alarming discovery by scientist Kevin McKernan, of DNA contamination in vials of Pfizer and Moderna Covid vaccines has raised significant concern in the scientific community. Meanwhile, the reported finding has attracted criticism from those quick to ‘demonise’ anyone questioning the safety, efficacy, and sanctity of the ‘vaccines.’

McKernan’s detractors – and there have been plenty of them – have criticised everything from lack of peer-reviewed publication to speculation about the viability of the anonymously sent vials. 

Now, don’t get me wrong. Criticism and open debate in scientific enquiry are good things. After the three years of censorship and stifled debate in science and medicine one thing is patently clear: freedom of speech is paramount to truth. 

Let’s be clear on another thing. The peer-review system is essentially broken. The same players with vested interests in the pharmaceutical industry curiously have the same influence on the research and publication industry. As McKernan rightly points out, ‘[t]he market will validate this finding long before traditional peer review even puts its boots on. Independent wet lab reproduction trumps 3 anonymous readers every time.’ This, then was the motivation behind publishing the results online with a call-to-action for scientists in the field to independently verify the results. 

Answer the call they did. McKernan’s results – for the Pfizer product (BNT162b2) – have now been independently verified by a number of internationally recognised laboratories confirming both the presence and levels of DNA contamination across different vials and batches. 

So, in asking the question ‘Is the result reproducible?’ the answer (for the Pfizer product BNT162b2 at least) is ‘Yes.’ The contamination is real. These results now lead us to ask some other questions which hang heavily in the air. 

Questions like, ‘How bad is the contamination,’ ‘What are the regulatory authorities doing about it,’ and – the question on everyone’s lips – ‘What does this mean for the billions who took the jab?’ 

These questions deserve answers.

So, how bad is the contamination? There are two things to consider here.

Firstly, what are the levels of contamination and secondly what are the components of the contamination.

As previously reported, levels of DNA contamination in the Pfizer BNT162b2 product came in around 18-70 times over the limits set by regulatory authorities. These levels of contamination have also been confirmed independently.

To put some perspective on these numbers McKernan explains in terms of PCR testing for Covid.

‘You were probably swabbed with one of those nasal swabs to get a Covid PCR. You would be called positive of a CT (cycle threshold) under 40. We’re getting CTs under 20 with the contamination of the vaccine. That’s a million-fold more contamination than you would be called positive for having a virus. Now, the virus they’re swabbing is outside of your mucosal membrane in your nose. We’re talking about a contaminant that’s getting injected, bypassing your mucosal defences at a million-fold higher concentrations…There’s an enormous difference here in terms of the amount of material it’s in there.’ 

The manufacturing process, as discussed in a recent BMJ article, points to how the DNA contamination may’ve occurred.

The clinical trials were run using ‘Process 1’ which involved in vitro transcription off synthetic DNA – essentially a ‘clean’ process. However, this process is not viable for mass production, so the manufacturers switched to ‘Process 2’ to dial things up. Process 2 involves using E. coli bacteria to replicate the plasmids.

Getting the plasmids out of the E coli. can be challenging and result in residual plasmids in the vaccines. But there’s another concern. When plasmid contamination is found, there is a potential for bacterial endotoxin to also be present. This endotoxin can produce serious side effects if injected including anaphylaxis and septic shock. Australian Professor Geoff Pain remains most vocal providing extensive details on these endotoxins.

Sequencing of the plasmids from the Pfizer vials resulted in another ‘accidental’ discovery. Something was found that wasn’t in the sequence map disclosed by Pfizer to the EMA. This something is called a SV40 promoter. The SV40 promoter is a sequence that turns on gene expression, like a switch. It is also a potent nuclear localisation signal, meaning it makes a beeline for the nucleus. The entire SV40 genetic sequence came to infamous prominence in the 1960s having been found to have polluted the Salk polio vaccine, causing a subsequent surge in cancers. We’ll return to the concerning significance of the SV40 promoter sequence in a moment.

Subsequent experiments suggest that most of the DNA contamination is fragmented, which is by no means benign. McKernan states, ‘(Much of) the DNA is actually linear because they do go through a step trying to fragment this and (linear DNA) has a higher propensity for integration than circular plasmid DNA.’ It seems that a significant amount of the DNA is in this form and presents a greater risk to humans in terms of risk for integration into the genome, than the circular DNA. 

To make matters worse – as if things could get any worse – it appears that much of the DNA is packaged in the lipid nano particles (LNP).

‘If the DNA is actually in the LNPs, we have different risks, as… this will then transfect the mammalian cells and become a genetic alteration. Now, whether it integrates with the genome is secondary, the fact that you’re getting foreign DNA into the cell is a risk in and of itself, because it could partially get expressed, or it could muddle around with other transcription, translation machinery that’s in there,’ McKernan explains.

Let’s recap. We have DNA, which is mostly packaged in LNP designed to travel all over the body and enter cells, delivering it’s genetic cargo like a trojan horse. Some of this DNA may contain the SV40 promoter sequence – the one known to make a beeline to the nucleus and turn on gene expression. McKernan states an obvious concern, ‘If (the SV40 promoter) becomes integrated into the genome it will turn on gene expression wherever it lands. If this happens to be an oncogene (a cancer-causing gene), you’ve got problems.”

This, dear reader, is only one of the many possible adverse effects from injecting synthetic DNA into humans. 

The scientific literature acknowledges the potential for foreign/synthetic DNA alone to be oncogenic (cancer-causing), infectious, and prothrombotic. In addition, genomic integration of a viral promoter like SV40 can contribute to cancer and is well known to cause leukemia in gene therapy trials.

You can see why scientists are alarmed. These concerns were presented to the FDA on the June 16, 2023. What have they done with this information you ask? Probably filed it in a box somewhere in a deep dark warehouse between the words ‘conspicuous’ and ‘conspire’ is my guess.

When we consider the above it is clear why strict legal rules exist in the field of genetic science especially where humans are involved. Rules designed to (actually) keep people safe from the potential known and unknown consequences of messing with the genetic integrity of human life. Which brings us to the next question: 

‘What are the regulatory authorities doing about it?’ From what we can tell, nothing. 

The independently verified contamination alone heralds a serious quality control issue which behooves immediate attention from the likes of the FDA, TGA and EMA. Combined with significant adverse event data and climbing excess mortality rates around the world these shots should have been pulled over two years ago. Indeed, we would postulate they should never have been approved. 

This unfolding story is by no means over. Serious questions have been raised asking whether these products, which have been injected into billions around the world, were approved illegally.

The disturbing revelation was raised in a recent landmark publication by one of the authors. It appears that even without the DNA contamination ‘the so-called “vaccines,” from the beginning fulfilled the legal definitions for being categorized as genetically modified organisms.’ They therefore required GMO licences. It would appear those licences are missing.

The Australian Federal Court is being asked to consider this issue in proceedings recently filed under the Gene Technology Act against Pfizer and Moderna.

Australia’s TGA and the Office of the Gene Technology Regulator were thoroughly informed of the GMO and synthetic DNA contamination by the lawyers responsible, but neither office has bothered to reply nor comment.

In a statement to the press, instructing solicitor Katie Ashby-Koppens says, ‘We took this case on because neither of the appropriate regulators were doing anything about it. The Therapeutic Goods Administration and Office of the Gene Technology Regulator were both put on notice in 2022 that these products contain GMOs and they have failed to act. It has been left to citizens to do what the Australian Government won’t do.”

“Every single person who has been injected with these products has received a GMO that has not been through the expert regulatory process in this country. The human genome could be changed permanently, and no one was informed.”

If all this bares out, at best the regulatory bodies have failed in their duty to protect the people. At worst they have been complicit in a crime with consequences for the world’s population and generations to come.

To answer the final question the question on everyone’s lips: ‘What does this mean for the billions who took the jab?’ We may soon start answering this question more precisely, with the development of qPCR kits to differentiate between Long Covid and Long Vax, and determine whether vaccine sequences are present in human tissue samples.

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Dr Julie Sladden is a medical doctor and freelance writer with a passion for transparency in healthcare. Her op-eds have been published in both The Spectator Australia and The Daily Declaration. In 2022, she was elected as a Local Government Councillor for West Tamar in Tasmania.

Julian Gillespie is a lawyer and former barrister in Australia, known for his Covid-19 research and advocacy. His work includes seeking to have the provisional approval of Covid-19 vaccines declared legally invalid due to failures to meet regulatory standards. Julian is also a director of Children’s Health Defense, Australia.

Featured image is from Children’s Health Defense


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