The truth behind the Green Monkey story
Summary
The production methods of Pfizer and Moderna’s COVID-19 vaccines have been thrown into the spotlight due to the discovery of DNA contaminants in the vaccine vials by genomic scientist Kevin McKernan. The DNA found was not only considerable in quantity but also protected by the lipid nanoparticles used for mRNA delivery, implying potential delivery into human cells.
Additionally, a promoter from the SV40 virus, undisclosed in initial vaccine data, was found within the DNA. The presence of this promoter has raised serious questions about the oversight and regulatory processes in vaccine manufacturing. Despite the speed and economic advantages associated with mRNA vaccine technology, concerns around DNA contamination underline the importance of rigorous safety checks.
Introduction
This report aims to shed light on the actual implications of McKernan’s findings of DNA contaminants in the vaccines, exploring the nature and potential impact of the DNA contaminants in the vaccines. It also delves into concerns over the lax regulatory oversight and the potential risks posed by DNA contamination for future RNA vaccines.
Background
Synthetic mRNA forms the backbone of Pfizer and Moderna’s COVID-19 vaccines. The mRNA was produced in a cell free environment in a laboratory where a DNA template was used with a cocktail of enzymes and nucleic acid building blocks to produce the mRNA. The DNA template was originally created in bacteria.
As well as a nucleoid (the bacterial equivalent of a nucleus), bacteria have circular strands of DNA, called plasmids, in their cytoplasm. It is relatively easy to introduce DNA into the cytoplasm of bacteria. The bacteria use the DNA to make mRNA and then use that to make protein. Bacteria regularly exchange these plasmids, or parts of them and that is often how bacteria become antibiotic resistant. Researchers hijack this system to use bacteria to make what they need.
Plasmids were created in bacteria that contained the spike gene and antibacterial resistance genes. This meant any contaminant bacteria could be killed off using the antibiotics and selecting for the ones with the spike plasmid. These were then harvested for use as a template.
Contaminants
Kevin McKernan, a seasoned genomic scientist and former team leader for the MIT Human Genome project, serendipitously found through sequencing that the vials contained more than he was expecting.
While troubleshooting a sequencing issue, McKernan used Pfizer and Moderna vaccines, sent to him anonymously, as mRNA controls. His assumption was that these would be pure samples that could assist him in overcoming his mRNA sequencing issues. However, he unexpectedly found that these vaccines weren’t entirely pure mRNA; they contained substantial amounts of DNA – over the safety limits. Even those ‘safety’ limits are questionable as it is not clear what even a small amount of contaminant DNA might do. Purification of the mRNA is expensive to do but it is really important to remove DNA and any damaged mRNA. It clearly was not done adequately (if that is even possible).
Quantity and Delivery
The DNA that was present was broken up or fragmented. As such, the likelihood of encountering a segment carrying the full genetic blueprint for the spike protein is quite low due to the length of that specific sequence. However, the possibility remains that whole spike DNA may have been injected on occasion.
Despite the fragmented nature of the DNA, the amount of DNA he found was not small. McKernan makes the following comparison. If you tested positive from a nasal swab (with a weak positive test) then the number of viral mRNA sequences present in the solution described as positive would be 1 million times lower than the amount of contaminant DNA present in the vaccine vials that was injected into the body.
The risk of injecting this DNA will depend on whether the DNA was naked, which would be a clotting risk, or contained inside the lipid nanoparticles which would allow them to be delivered into cells. Given that the lipid nanoparticles are designed to circulate around the whole body and enter every organ, particularly the spleen, adrenal glands, liver and ovaries, any cell in the body could have had this DNA delivered. The idea that distribution could be restricted by injecting into muscle rather than the vein is easily shown to be erroneous given that an intramuscular injection with an Epipen can deliver adrenaline into the blood fast enough to save a life from anaphylaxis.
To determine which of these scenarios was present in the vials he therefore did an experiment. First, he showed that using enzymes that destroy DNA but can’t enter the lipid nanoparticles did not destroy the DNA. Next he heated the vials before adding the enzyme, to damage the lipid nanoparticles. This time the DNA disappeared showing it was protected by the lipid nanoparticles. That means the DNA would be delivered into cells along with the mRNA.
Bonus Pfizer DNA
The Pfizer DNA itself had another secret surprise. McKernan found the Pfizer DNA was not the same as the sequence they had published and declared to the EMA (European Medicines Agency. There was additional material in there. The EMA submission said there were two genes – the spike gene and the antibacterial resistance genes. There was also a sequence for each gene that is like a flag telling the cell “make me!” – these flags are called promoters. The promoters for the spike protein and antibiotic resistance genes were both ones that bacteria can respond to. However, there was also another promoter in the sequence. This was a promoter that cannot be read by bacterial cells – it tells animal cells including human cells “make me!” This particular promoter was originally from a virus that infected green monkeys called SV40.
The SV40 virus contains a cancer promoting gene but that gene was NOT present in the plasmids. Only two small regions of the virus were. The SV40 promoter and a nuclear localization signal. The nuclear localization signal enables the plasmid DNA to enter the nucleus. The Moderna plasmid did not have this promoter and, to reiterate, neither did the official Pfizer sequence. It should not have been there.
What might the DNA do?
For DNA to change a cell it needs to be located in the nucleus. On the other hand, mRNA will initiate the production of protein from the cytoplasm. This is not thought to be possible with DNA alone.
A SARS-CoV-2 viral infection causes viral RNA to enter the cytoplasm and replicate. Occasionally this RNA got turned into DNA and then integrated into the cell’s DNA. This was demonstrated in December 2020 by a research team at MIT. The consequence was that epithelial cells in the respiratory tract would keep producing spike protein until they died. This is why testing for covid should not be repeated for 90 days after an infection. The cells had to die before the viral proteins disappeared.
Furthermore, the vaccines, when added to liver cells in culture, resulted in spike DNA being produced in the cells within 6 hours. This was believed to be due to mRNA being changed into DNA rather than through there being DNA in the vials.
The risk of the foreign DNA being integrated into the human genome will be higher if there is DNA in the vial rather than mRNA alone. The presence of the nuclear localization sequence will increase the risk considerably. Circular DNA would be less of a risk for integration but McKernan reported that much of it was in fact linear. The integration risk is higher if DNA is present but the risk of spike integration would be lower if the spike DNA is fragmented. The Australian regulator showed images which clearly showed that the S1 portion of the spike was present inside the nucleus in cells in culture when vaccine mRNA was inserted into their cytoplasm. (The bright green area is the golgi apparatus outside the nucleus. The nucleus should not be green at all (see control image below). The dark area within the nucleus that is not green is the nucleolus and it did not penetrate there).
It has been shown that spike protein from the vaccines still circulates at least 4 months after vaccination. What was driving it? Either the synthetic mRNA, which was modified to stop it breaking down, was still working or DNA might have integrated into the nucleus. It is an important question and the fact this is not understood even now is shameful.
What would happen if the SV40 promoter integrated into DNA? In theory, it could end up anywhere in the human genome. As with any DNA integration there is a risk that it harms genes that limit growth or increases production of genes that promote growth and the result would be an increased cancer risk for that cell. While this may only happen at a rate of about one in a million, when you consider how many cells were at risk in each person the risk per person becomes more significant. Keith Peden, Chief of the Laboratory of DNA Viruses in the office of Vaccines Research at the FDA, showed, with a team, in 2008 that contaminant DNA from vaccine production could lead to cancers in animal models.
Up to 20% of the population are already infected with SV40. They therefore do have the cancer promoting gene latent in their system. There is a risk that adding the SV40 promoter sequence will reactivate this gene increasing their cancer risk. There are a lot of “ifs” in these eventualities but it is precisely these scenarios that result in strict limits on how much DNA is allowed in the vaccines.
There is also a theoretical concern that circulating lipid nanoparticles could pass through gut cells and deliver the DNA to gut bacteria. If this happened the bacteria could gain antibiotic resistance.
Who is responsible?
Could it be accidental? Bacteria share DNA with other bacteria all the time through recombination. SV40 promoters are used in plasmids in laboratories and perhaps some cross contamination led to the bacterial plasmid DNAs being contaminated with SV40. However, the likelihood of this DNA recombination happening in such a way that it neatly integrates between existing promoters and genes without disturbing them or bringing in a range of new DNA sequences would be very low. Genetic recombination is a random process, and it’s far more likely that such an event would disrupt existing genetic structures rather than integrate neatly. Furthermore, an accident would imply that no-one had done this simple check of seeing what was being produced! The regulators relied entirely on what the pharmaceutical companies claimed in their paperwork.
Was there something nefarious about this? Why was the SV40 promoter so neatly inserted? What was an animal cell promoter gene doing in the plasmids at all? However, if intending to add something harmful then why not add the SV40 gene rather than just its promoter?
One possibility is that various plasmids can be purchased “off the shelf” and this looks like a classic backbone for a plasmid. One promoter turns on the antibiotic resistance gene so that the bacterial selection can take place. The SV40 turns on a neomycin resistant gene which is toxic to animal cells in culture such that those that contain the plasmid can be selected. It might be that, for some reason, a different plasmid was used without informing the regulator.
Regardless of whether the presence of the SV40 promoter was accidental or intentional, one thing is clear: there’s been a significant lapse in oversight. Even if those responsible for manufacturing failed to pick up on these issues the regulator should have. Instead, they have all been very hands off. For example, the EMA did not even check the manufacturing for the main production site in Europe. The EMA contracted for the Pfizer/BioNTech vaccine to be produced mainly in Belgium (see bottom of page 12). However, the EMA accepted a submission on manufacturing from only the US site in Andover saying, “It is expected that no significant differences between the two processes are envisaged.” This complacency in performing due diligence represents a catastrophic failure for which there needs to be accountability.
What does this mean for other RNA vaccines?
To scale up and be economical, any mRNA vaccine will have to use this bacterial manufacturing method. The risk of DNA contamination will therefore apply to any future RNA made this way.
If the purification steps failed to remove the bacterial plasmids then a question arises as to whether they removed the rest of the bacteria. Endotoxin in the outer membrane of E coli causes septic shock. It was present in vaccine vials and could be a cause of anaphylaxis. Leaked documents submitted to the EMA show that in testing the endotoxin levels were higher than in the research batches. Other documents have redacted that information as if it is a commercial secret ingredient. Endotoxin has also been suggested as the causative agent for vaccine induced myocarditis.
It is important to note that in the trials the RNA was synthesised in a research laboratory. However, the template and purification as well as other steps were altered for mass production. In the Pfizer trial, only 250 participants were given vaccines produced using the methodology for mass production, the other 21,470 were given the small scale carefully produced mRNA. It was noted that the placebo group, who were given the mass produced vaccines after a few months, had higher levels of adverse reactions compared to those given the research batches.
In December 2022, the government signed a ten year contract with Moderna to produce 250 million mRNA vaccines every year in the UK. The apparent need for mRNA vaccine technology is because it is claimed to be able to produce vaccines faster than conventional methods but that does not stand up to scrutiny. There are alternatives. During swine flu, egg based conventional vaccines were produced so quickly contracts were signed for them even before a ‘pandemic’ was declared by the WHO.
mRNA vaccine technology has been a disaster on many levels and the sunk costs of the expensive contract with Moderna should not be the deciding factor on determining whether it should be allowed to continue. The mass production approach, while economical, has revealed its downside—the risk of DNA contamination. This discovery has highlighted the lack of rigorous safety checks in the development of mRNA vaccines. The expediency and monetary advantages of mRNA technology should never have superseded the requirement for safety and accuracy. Thankfully, Kevin McKernan, a true and brave scientist, took the time and effort to unravel this complex DNA mystery and to alert the world.
