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Contamination in mRNA Shots ‘Serious Regulatory Oversight’

ByRebekah Barnett

The Author

Rebekah Barnett is a freelance writer and advocate for the Covid vaccine-injured. Read her work at Dystopian Down Under.

The discovery of excessive levels of DNA contamination in the mRNA COVID shots has raised questions about how it got there, and what it means for people who may have been injected with contaminated products. Scientists have some answers, and a lot of questions…

Earlier this year, Umbrella News reported that genomics scientist Kevin McKernan claimed to have found plasmid DNA contamination – anywhere between 18-70 times above legal limits – in the mRNA Pfizer and Moderna vaccines.

“I wasn’t actually looking for it,” McKernan said in an interview, in which he recounts being “shocked” at finding the contamination while running an unrelated experiment in his Boston lab in early 2023. McKernan posted his findings to social media, and other scientists began running their own experiments and sharing notes. 

One of these scientists was cancer genomics expert and mRNA proponent Dr. Phillip Buckhaults, who was initially skeptical of McKernan’s findings, until he replicated them multiple times in his own lab. On 14 September, Dr. Buckhaults, who has taken the mRNA vaccines himself, testified in a South Carolina Senate hearing that he too had found lots of “itty bitty bits” of plasmid DNA contamination in the mRNA vaccines, which he likened to scattered buckshot. 

Dr Buckhaults said that these DNA fragments, “may be causing some of the rare but serious side effects, like death from cardiac arrest. There is a very real hazard,” he went on, that the contaminant DNA fragments will integrate with a person’s genome and become a “permanent fixture of the cell,” leading to autoimmune problems and cancers in some people who have had the vaccinations. He also noted that these genome changes can “last for generations.”

The eminent Prof. Wafik El-Deiry, Director of the Cancer Centre at Brown University, shares Dr. Bukhaults’ concerns. He notes that the lipid nanoparticles casing around the contaminant DNA fragments provides a means for them to “now easily get in the cells. If they get into cells they can integrate in the genome which is permanent, heritable and has a theoretical risk of causing cancer depending on where in the genome they integrate.” 

Dr. Buckhaults and McKernan have noted that in the Pfizer vaccine (but not Moderna), the presence of an SV40 promoter sequence in the DNA contamination makes the possibility of genomic integration even more likely. This sequence was not disclosed in Pfizer’s submission to the regulators.

Pictured: Slides from Kevin McKernan’s presentation to the FDA, 15 June 2023. (Source: Kevin McKernan)

“It’s used in gene therapies,” explains McKernan, referring to scientific work out of Rochester University which shows that the SV40 promoter is “effective at getting DNA into the nucleus, which is what you need to make gene therapy work.”

Both scientists emphasise that the risks of genomic integration and adverse events from the DNA contamination are currently theoretical, and need to be tested in further studies. They also agree that these effects would probably be rare. 

However, McKernan says, “the end numbers are so large that you can’t rule it out. The number of molecules that are in each shot isn’t ‘one.’ It’s like a billion or more of these DNA molecules. So we have billions of contaminants going to billions of people.”

A new Canadian study of 27 mRNA vaccine vials just upped the ante on McKernan’s numbers, concluding that there are “billions to hundreds of billions of DNA molecules per dose” in the Moderna and Pfizer mRNA shots. The preprint, which is about to go through peer review, assessed vaccines from lots approved for children, and several of the bivalent boosters, including Moderna’s XBB.1.5 booster. 

Multiple other labs around the world now claim to have replicated McKernan’s finding of plasmid DNA contamination in the shots, which is thought to be a by-product of the upscaled production method.

The process used for mass manufacture of the mRNA vaccines involves using E. coli bacteria to make copies of DNA plasmids, from which the vaccine mRNA is then produced. It is fragments of these bacterial DNA plasmids that have since been found in the mRNA vaccines. 

Testifying in the same South Carolina Senate hearing after Dr. Buckaults, toxicologist and microbiologist Dr. Janci Lindsay added a few more concerns about the production process of the mRNA vaccines to the mounting pile. 

While most of the plasmid DNA fragments detected in the vaccines have been relatively small, if some are larger and intact, “they can infect the E. coli in your gut… which means you can be a perpetual spike factory, because they’re self-replicating,” said Dr. Lindsay. “That’s a problem.”

Dr. Lindsay stated that the DNA fragments carry an antibiotic resistant gene which can make your gut bacteria resistant to commonly used antibiotics. “If these transfect the E. coli in your gut, it can make your gut and other bacteria resistant to those antibiotics. That is a huge, huge risk.”

A third risk raised by Dr. Lindsay is the possibility that the vaccines are contaminated with endotoxin, which is the outer membrane of the E. coli bacteria used to grow DNA plasmids. Endotoxins, “can cause anaphylaxis and even death. And that may be what caused some of the rapid deaths that occurred right after people got these shots,” explained Dr. Lindsay. 

The possibility of endotoxin contamination in the mRNA vaccines was raised by Australian scientist Dr. Geoff Pain at an independent inquiry into Australia’s excess mortality, at Parliament House on 18 October 2023. 

With the alleged presence of DNA contamination and its concomitant theoretical risks based on the scientific literature and pharmacovigilance databases, one might imagine that the regulators would respond with alarm. 

Umbrella News sent their findings to the TGA for comment, and a spokesperson for the TGA responded questioning the methods used by McKernan and Dr. Buckhaults, and noting that their independent findings had not yet been through peer review. The TGA also asserted that the provenance of the vaccine vials was unknown, though this is not the case with vials tested in Dr Buckhaults’s lab, which he says were sourced from the pharmacy associated with his lab, and therefore have chain of custody. 

On the prospect of DNA contamination in the mRNA shots, a spokesperson for the TGA said,

“As part of the batch release process, the TGA reviews the manufacturer’s test results for residual DNA on every batch of vaccine supplied in Australia. Only batches of mRNA COVID- 19 vaccine meeting the approved specification for residual DNA are released. 

“DNA is used in the early stage of mRNA vaccine manufacture. The vaccine manufacturing process includes various purification steps with appropriate controls and tests to ensure the removal of the plasmid DNA template from the final product. 

“The TGA has reviewed and evaluated the materials used for manufacture, the manufacturing process, and the analytical procedures used for testing the residual DNA template levels as part of the registration process for the vaccines. These were all found to be acceptable.”

The TGA has also previously advised Umbrella News that, “COVID-19 vaccines do not alter a person’s DNA. The mRNA in the vaccines does not enter the nucleus of cells and is not integrated into the human genome.” However, the TGA did not provide comment on the risks of genomic integration posed by the contaminant DNA fragments found in the vials. 

The TGA did not provide any scientific studies testing for genomic integration, cancer, or any of the other potential adverse events identified in the scientific literature as potential risks of DNA contamination.

That the regulators do not seem concerned about the alleged DNA contamination in the mRNA vaccines, said Dr. Buckhaults, could partly be because the current regulations around allowable DNA contamination limits are not suitable for this new type of vaccine. 

The difference lies in the distinction between whether the DNA contamination is ‘naked’ (as in traditional vaccines), or ‘packaged’ in lipid nanoparticle casing (as in new mRNA vaccines). A bit of naked DNA contamination is not a problem, Buckhaults explained, because it gets, “chewed up immediately upon vaccination, and there’s no real mechanism for it to get inside the cells.”

But with the introduction of the mRNA vaccines, the regulators, “inappropriately applied that regulatory limit to this new kind of vaccine where everything is encapsulated in this lipid nanoparticle… able to dump its content into a cell,” said Dr. Buckhaults. “I think this is a real, serious regulatory oversight that happened at the federal level.”

At an expert hearing on the DNA contamination issue hosted by the World Council for Health on 9 October, world-leading scientists and medical professionals, including McKernan and Dr. Lindsay, presented on the risks of the contamination in the shots and offered a six-point call to action to mobilise the scientific community in advancing research and legal action on the matter.

While Dr. Buckhaults remains optimistic about the future of the mRNA platform, particularly as a potential treatment for cancers, he stated that he will not be taking any more of the mRNA COVID vaccines without first testing them to ensure they are free from contamination. 

Dr. Lindsay is less optimistic, stating, “I disagree with Dr. Buckhaults in that I think this is the most dangerous platform that has ever been released on mankind.” Dr. Lindsay is campaigning for the shots to be suspended until pharmacovigilance safety signals have been properly investigated. 

Despite their differences, all the scientists involved agree on two things. First, the DNA contamination is there. Second, there is an urgent need for further research to test whether the contaminant DNA fragments are lingering in the cells of mRNA vaccinated people, whether they are causing adverse events, and whether they are integrating into the genome of vaccinated people.  



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