What is the DNA contamination problem in the first place?
Kevin McKernan discovered DNA contamination in mRNA vaccines.
- McKernan is an expert in DNA analysis.
- He was working on mRNA vaccine quality issues.
- Feb. 2023 DNA contamination was publicized on Substack, called PlasmidGate, and became a big problem.
Mr. McKernan is an expert in DNA analysis and was originally working on the quality problem of mRNA vaccines. Substack is like a "note" in Japan. This was called PlasmidGate, and it gradually became a big problem.
This is called PlasmidGate, and it became a bigger and bigger problem.
解説/Explanation
To begin with, let me explain what the DNA contamination issue is.
DNA is used as a template for mRNA production, and it is increased in E. coli.
- mRNA uses DNA as a template.
- The template DNA is a spiked gene introduced into a ringed plasmid
- Cultivate E. coli to produce a large amount of plasmid DNA as a template
- T7 RNA synthetase synthesizes large amounts of mRNA
mRNA uses DNA as a template. The template DNA is a plasmid, which is a circular, or looped, double-stranded DNA, into which the gene for the spike protein is introduced. This plasmid is then introduced into E. coli and cultured to produce a large amount of plasmid DNA as the template. The plasmid DNA is purified by removing the original linear DNA of E. coli and E. coli, and a large amount of mRNA is synthesized by T7 RNA synthetase.
解説/Explanation
DNA is used as a template for mRNA production and increased in E. coli. Detailed explanation.
DNA to be removed could not be removed in principle.
- Insufficient reaction to cleave the cyclic plasmid with restriction enzyme
- Synthesized mRNA binds tightly to DNA and inhibits DNA degradation
- Methylation and GC richness characteristic of mRNA vaccines create strong binding
- DNA/RNA hybrids were formed
There are several possible reasons. Insufficient reaction to cleave the circular plasmid with restriction enzymes. The synthesized mRNA bound tightly to the DNA and inhibited DNA degradation. The methylation and GC richness characteristic of the mRNA vaccine resulted in strong binding and the formation of DNA/RNA hybrids.
mRNA is contaminated with DNA.
解説/Explanation
The DNA must eventually be removed, but in principle it could not be removed, which is the problem in this case.
What is the problem if mRNA is contaminated with DNA?
- Human DNA must not be altered without the consent of the individual.
- UNESCO "Universal Declaration on the Human Genome and Human Rights".
- International treaty called "Cartagena Protocol on Biological Diversity
- Reverse transcription of mRNA was also a concern, but DNA contamination can directly alter the genome
- DNA fragments are wrapped in LNPs (lipid nanoparticles) and can be easily introduced into the genome.
Human DNA should not be altered without the consent of the individual. UNESCO's "Universal Declaration on the Human Genome and Human Rights" declares that "the human genome and human rights" should not be altered without the consent of the individual. There is also an international treaty called the Cartagena Protocol on Biological Diversity.
The introduction of mRNA into DNA by reverse transcription was also a concern, but the probability was said to be low. However, there were studies in which spike proteins were actually detected for many months, and it was suspected that they had been introduced in some way; DNA contamination would increase the likelihood of direct genome modification. Especially in the case of mRNA vaccines, DNA fragments are wrapped in LNPs (lipid nanoparticles), allowing for easy DNA introduction.
解説/Explanation
What is the problem when mRNA is contaminated with DNA?
Why is this issue important?
- DNA residues that could reveal the original sequence are a problem in and of themselves.
- The validity is not clear, but there is a safety standard, and it is above the standard.
- Note that it does not mean that it is safe if it is below the standard value.
- Could it be a cause of adverse reactions/adverse events? Could it promote cancer? What about genetic effects?
- The same problem will occur with future mRNA products and replicon vaccines.
DNA residue to the point that the original sequence is known is a problem in itself. Safety standards have been established, such as less than 10 ng per inoculation, or 1/3000 of mRNA, etc. The validity of these standards is unknown. The validity of these standards is unclear, but at any rate, safety standards have been established. However, even these standards have been exceeded. Please note that this does not mean that if the levels are below the standards, it does not mean that they are safe.
There is a suspicion that DNA contamination is one of the causes of adverse reactions and adverse events, and that it may promote cancer. This is not to say that there are not other factors, or that DNA contamination is the primary cause, but that there are many other problems with mRNA that are also significant. It may be the biggest problem in the long run, and the biggest problem for the future of humanity in terms of its effect on genes.
DNA contamination is also likely to be a problem with future mRNA products and replicon vaccines. It is feared that it will also cause great damage.
解説/Explanation
Let me explain why I think this issue is important.
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