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Theme: Calling and challenging for quantitatively eliminating the underestimation of the DNA contamination in the qPCR
◆The estimated amount of the DNA contamination when the underestimation is eliminated significantly exceeds the regulation amount.
Regarding the Pfizer Wuhan-type vaccine according to the study of Buckhaults, the estimated amount of the DNA contamination of the lot number EL9262 is 109 [ng/dose], and the estimated amount of the DNA contamination of the lot number EL9264 is 79.4 [ng/dose]. Additionally, regarding the Moderna vaccine according to the study of Mckernan, the analogical estimated amount of the DNA contamination is 116 [ng/dose].
The problem of the plasmid DNA contaminations in the Covid mRNA vaccines was reported by McKernan in the substack on February 16, 2023, and the preprint thereof was filed on April 10 in the same year (ref. 1). In this preprint, three DNA contamination amounts were identified by means of three methods including the qPCR. It is known that the qPCR underestimates the DNA contamination amount due to natures of the mRNA vaccine manufacturing method and the measurement method.
For example, Moderna has self-acknowledged the underestimation of residual DNA (DNA contamination) in the qPCR in their patent US10077439B2 (ref. 2, p.16, section 19), and this discovery is still fresh in our minds. The filing date of this patent is March 13, 2014, before the outbreak of the new coronavirus, and one of the inventors of this patent is Stephane Bancel, the CEO of Moderna. Moderna also has explicitly self-acknowledged in this patent that the residual DNA is to be oncogenic and must be removed (p.7, section 1).
Furthermore, another Moderna patent US13/791922 (US20130259924A1, Stephane Bancel, et al.) has been incorporated into the above patent (ref. 2, p.10, section 8) by reference for all purpose teaches that the DNA introduced into a cell can be inherited by offspring (ref. 4, para [0006]). Additionally, the other Moderna patent US20190240317A1 teaches the insertional mutagenesis due to the naked plasmid DNA (ref. 5, para [0012]).
The above patent US10077439B2 (ref. 2) has cited the FDA guideline (ref. 6) in its end of the specification (p.18, section 24), and this FDA guideline teaches multiple risks related to the residual DNA including insertional mutagenesis, oncogenesis, and genetic integration (ref. 6, p.37).
It is obvious from those facts that the DNA contamination has a different mechanism of action from an originally intended mechanism of action of the vaccine, and it goes without saying that the DNA contamination may cause a fatal side effect on the human body.
Despite Moderna and FDA were aware of the above events, Moderna used the qPCR to detect the residual DNA amount in their actual manufacturing process for the mRNA vaccine (ref. 3, p.109), and FDA permitted it. They have continued to ignore the problem of residual DNA to this day even though they have been aware of the risks of residual DNA.
FDA has set the regulation amount of 10 [ng/dose] and below 200 [bp] for the DNA contamination (ref. 6, p.37). However, this is not the regulation amount for the residual DNA wrapped by the LNP (LNP-DNA), but for the naked DNA.
The LNP-DNA has superior long-term durability to the naked DNA and has the property of easily inducing the residual DNA into a cell. It is therefore obvious that the LNP-DNA has a different mechanism of action from that of the naked DNA, and it is extremely inappropriate for the previous regulation amount (=10 [ng/dose], <200 [bp]) to be directly applied to the new LNP-DNA technology.
However, since there is no regulation amount for the LNP-DNA, we cannot help but following the previous regulation amount for the naked DNA. An act of wrapping the residual DNA with the LNP and introducing it into the human body is an ethical issue and should not be permitted in any amount since safety cannot be guaranteed.
It goes without saying that their such acts were caused intentionally or through gross negligence as it is obvious from the above documents, and thus such fatal flaws in the regulatory authorities are needed to be rigorously pursued.
The underestimation in the qPCR is a fundamental problem that directly relates not only to the regulated amount of the DNA contamination but also to human life, and thus to quantitatively eliminate it means a great advance in the DNA contamination problem.
Researchers focusing on the problem of DNA contamination have been aware of the underestimation caused by the qPCR but have not made any efforts to eliminate it. Researchers should not turn away from this underestimation problem and should take a stand toward eliminating the underestimation.
We intensively investigated a method to eliminate the underestimation based on the experimental results disclosed by McKernan and Buckhaults. The purpose of this post is to provide a first step for eliminating the underestimation in the qPCR.
The estimated value at present point shall now be disclosed hereinafter, but a certain correction value may be added depending on future experimental results, etc. However, we believe that a method for eliminating the underestimation has been established to some extent and disclose this here.
We also believe this post will provide deep insights and further perspectives on the DNA contamination problem to many researchers. We expect that excellent researchers will give further consideration to this.
This post updates and specifically explains the calculation method for the DNA contamination shown in the past post from mbi (ref. 7).
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