Carelessness, Randomness, Irresponsibility, Sloppiness, Inattention, Slackness (C.R.I.S.I.S)
Assessing the negligence behind COVID-19 genetic vaccines
More than four years after the introduction of genetic vaccines against COVID-19, I am continually astonished by the alarming findings emerging from scientific studies. The controversial aspect is that these pharmaceutical products have been presented to the public (and this phenomenon continues to this day) as the result of highly advanced scientific progress, claiming to be “safe and effective”. Nevertheless, based on the scientific evidence that continues to emerge, the truth looks to be diametrically opposed: These pharmaceutical products seam to be the result of total negligence. “Carelessness”, “randomness”, “irresponsibility”, “sloppiness”, “inattention”, “slackness” are terms that, in my opinion, most accurately reflect the several concerning issues surrounding genetic vaccines against COVID-19, which led to a health CRISIS characterized by serious adverse effects.
And I have to admit that I am obliging myself to believe that it is merely a matter of negligence, rather than succumbing to more nefarious interpretations that suggest malevolence…
For the sake of brevity, I will provide only a few key examples that prove the degree of negligence involved in the production and administration of these pharmaceutical products to billions of people, including infants and pregnant women.
They don’t know exactly what the vials contain:
It seems incredible, but what was once presented as a crazy conspiracy theory has turned out to be true. The mRNA vaccines contain high level of residual replication-competent plasmid DNA contamination.
Several independent researchers, including Dr. Kevin McKernan, Prof. Phillip Buckhaults, Dr. Janci C. Lindsay and Prof. Klaus Steger, have reported DNA contamination and have made significant efforts to raise awareness within the scientific and regulatory communities [1–5]. Unfortunately, most of their studies remain in preprint after almost two years. I wonder why..?
Finally (and surprisingly), the FDA has recently decided to do what it should have done before the start of vaccination campaigns, by analyzing samples of Pfizer and Moderna vaccines obtained from BEI resources, which is an NIH-supported program managed by the American Type Culture Collection (ATCC) [6]. The study conducted in the BSL-1 research facility at the FDA White Oak campus, by students under the supervision of FDA researchers, found that levels of residual DNA in a single human dose were 6 to 470 times higher than the FDA’s acceptable limits (10 ng/dose).
It is astonishing that this contamination was only identified after billions doses have already been inoculated. Given that such experiments are relatively straightforward (as demonstrated by students successfully completing the work), why weren’t these tests conducted earlier?!
Isn’t it a serious oversight and a grave act of negligence not to have conducted these tests before vaccinating billions of people, including infants and pregnant women?
They don’t have a clue of how these DNA residues might interact with human DNA, and which potential health consequences could arise:
DNA contamination arises from the production process of mRNA vaccines, which involves the use of plasmid vectors in which the gene encoding the spike protein is cloned. After the transcription to mRNA by RNA-polymerase, the producers decided to use DNase to fragment the plasmid DNA into small pieces in order to get rid of it [3]. However, as Prof. Buckhaults stated during his hearing in the South Carolina Senate on September 15, 2023, fragmenting the DNA increases the likelihood of integration by raising the number of fragments that could potentially integrate into different sites within the host genome (Figure 1)[3].
Figure 1. Screenshot from the recording of Prof. Buckhaults’s testimony before the South Carolina Senate on September 15, 2023 (https://rumble.com/embed/v3g2vny/?pub=rgzyb).
Isn’t it a grave irresponsibility to “sweep the dirt under the carpet” trying to eliminate the DNA by chopping it into pieces, without adding a proper purification step in the production process, and without testing the potential genotoxic effects of these contaminants?
And what to say about the presence of DNA sequences from the Simian Virus 40 (SV40) [1,2]? As Dr. Janci C. Lindsay correctly pointed out during her hearing before the South Carolina Senate on September 15, 2023, and in our paper, which by the way remains in preprint after several submissions: “What is the purpose for the addition of a mammalian promoter and nuclear targeting sequence from the SV40 oncovirus in the plasmid used in the manufacturing process of the Pfizer/BioNTech genetic vaccine, supposedly meant to only be used to grow copies in bacteria, where a mammalian promoter and obviously a nuclear targeting sequence, is not needed?” [7].
Isn’t it an unexplainable negligence to include in the replication-competent plasmid sequences from a virus which is known for his potential to cause carcinogenesis, due to its ability to cause insertions in the host DNA [8,9]?
They don’t have a clue about where the vaccine-derived genetic material spreads within the body:
Three years ago I have tried to warn the scientific community about the risks of the distribution of the genetic vaccines beyond the injection site (Figure 2), hypothesizing for the first time the autoimmune inflammatory mechanism which is responsible for the vaccine-induced myocarditis [10].
Figure 2. Taken and modified from Polykretis, Scandinavian Journal of Immunology, 2022.
That paper, which has been immediately marked as disinformation by the propaganda machinery, proved to have captured the point precisely. However, the indiscriminate vaccination campaigns continued unperturbed, leading to several adverse reactions among vaccine recipients due to the off-target distribution of the vaccine-derived genetic material [11]. The tragic case of a 14-years-old Japanese girl, who died of multi-organ inflammation two days after receiving the third dose of the Pfizer/BioNTech vaccine, resembles these dramatic adverse effects [12]. The histopathological data show infiltration of inflammatory lymphocytes in the heart, the lung, the liver, the kidney, the diaphragm, the stomach, the duodenum, and the bladder (Figure 3).
Figure 3. Histopathology of the (a) heart, (b) lung, (c) liver, (d) kidney, (e) diaphragm, (f) stomach, (g) duodenum, and (h) bladder, showing infiltration of inflammatory cells [source: Taken and modified from Nushida et al., Legal Medicine, 2023].
It is extremely concerning the fact the pharmaceutical companies and the regulatory agencies were aware of the risk of off-target distribution, as it proves the assessment report by the European Medicines Agency [13], based on the Pfizer study n° 185350 performed on rats [14], which at page 47 states: “Over 48 hours, distribution from the injection site to most tissues occurred” (Figure 4).
Figure 4. Screenshot taken from pag. 47 of the EMA Comirnaty® Assessment Report.
So they knew about the risk of off-target distribution, and despite that they totally ignored it, inoculating billions people with these pharmaceutical products.
Who will apologize with the parents of the unfortunate 14-yars-old Japanese girl, who lost her life prematurely due to the grave negligence of a system that induced her to get inoculated with this not adequately tested pharmaceutical product?!
The study by Hanna et al. clearly illustrates the extent to which vaccine-derived genetic material can spread throughout the body, not only entering systemic circulation, but also reaching bodily secretions, such as breast milk [15].
They don’t have a clue about how long the vaccine-derived genetic material persists in cells, continuing to induce the synthesis of spike protein:
The scientific article which up to now presents the most alarming results about the prolonged synthesis of spike protein after vaccination, is the excellent paper by Prof. Shigetoshi Sano, which presents the case of a 53-year-old woman who developed vesicopapular lesions on her arm and papulonecrotic lesions on her legs upon the 3rd dose of mRNA vaccine (Pfizer/BioNTech) [16]. Through immunohistochemical analysis of the papular vesicles, using a specific antibody against the S1 subunit, the vaccine-derived spike protein was detected in the keratinocytes of the stratum corneum and the inner part of the epidermis, after 15 months (!!!) from vaccination (Figure 5). Furthermore, the vaccine-derived spike protein was also found in the sweat ducts and glands, raising significant implications.
Figure 5. (left) Histopathology of a papular vesicle on the hand; (center) detection of the SARS-CoV-2 spike protein using an anti-S1 subunit antibody; (right panel) overlay image (scale bar: 50 μm). The spike protein is present in the cornified layer (asterisk) and intraepidermally (arrows) [source: Taken and modified from Sano et al., The Journal of Dermatology, 2024]. Note that no staining for the SARS-CoV-2 nucleocapsid protein was observed, proving that the spike protein is vaccine-derived (data not shown).
They don’t have a clue about the actual effectiveness of vaccination in preventing SARS-CoV-2 infection:
Finally, we must consider that all the aforementioned risks of serious adverse effects occur in order to get inoculated with genetic vaccines which protection not only wanes in time, but even turns to negative (Figure 6), as it is proven by the retrospective cohort studies [17–19].
Figure 6. Cumulative incidence of COVID-19 disease for study participants stratified by the number of COVID-19 vaccine doses previously received [source: Taken and modified from Shrestha et al., Open Forum Infectious Diseases, 2023].
Taking into account all the abovementioned scientific evidence (and I have been brief, as there are many more studies I could cite), what type of informed consent has been provided to the public?
Therefore, the next time someone tries to persuade you to get inoculated with these pharmaceutical products, ask him the following simple yet crucial questions:
Could you tell me exactly, putting it in writing, what is inside that vial?
Can you tell me exactly, putting it in writing, where the vaccine-derived genetic material goes within my body?
Can you tell me exactly, putting it in writing, how long the vaccine-derived genetic material persists within my body?
Can you tell me exactly, putting it in writing, which tissues may synthesize the vaccine-derived spike protein and which could be the potential consequences for my health?
Can you guarantee, putting it in writing, that the vaccine-derived genetic material will not interact with my genome in any way?
Can you tell me, putting it in writing, which is the real protection that these pharmaceutical products provide over time, and which is the risk/benefit assessment?
If the person in front of you is unable to address your concerns, I suggest you to say bye and walk away.
Please share this article with everyone who deserves the right to truly informed consent. It will empower them to ask scientifically supported vital questions.
Panagis Polykretis, Ph.D. in Structural Biology
References
[1] K. McKernan, Y. Helbert, L.T. Kane, S. McLaughlin, Sequencing of bivalent Moderna and Pfizer mRNA vaccines reveals nanogram to microgram quantities of expression vector dsDNA per dose, (2024). https://doi.org/10.31219/osf.io/b9t7m.
[2] D.J. Speicher, J. Rose, L.M. Gutschi, D.M.W. PhD, K. McKernan, DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events., (2023). https://doi.org/10.31219/osf.io/mjc97.
[3] SC Senate Hearing - USC Professor Dr. Phillip Buckhaults, 2023: https://rumble.com/embed/v3g2vny/?pub=rgzyb (accessed January 15, 2025).
[4] SC Senate Hearing - Dr. Janci Lindsay, 2023: https://rumble.com/embed/v3glx79/?pub=4 (accessed January 15, 2025).
[5] BioNTech RNA-Based COVID-19 Injections Contain Large Amounts Of Residual DNA Including An SV40 Promoter/Enhancer Sequence - Science, Public Health Policy and the Law, (2024). https://publichealthpolicyjournal.com/biontech-rna-based-covid-19-injections-contain-large-amounts-of-residual-dna-including-an-sv40-promoter-enhancer-sequence/ (accessed December 13, 2024).
[6] T.J. Wang, A. Kim, K. Kim, A rapid detection method of replication-competent plasmid DNA from COVID-19 mRNA vaccines for quality control, Journal of High School Science 8 (2024) 427–439.
[7] P. Gentilini, J.C. Lindsay, N. Konishi, M. Fukushima, P. Polykretis, A Case Report of Acute Lymphoblastic Leukaemia (ALL)/Lymphoblastic Lymphoma (LBL) Following the Second Dose of Comirnaty®: An Analysis of the Potential Pathogenic Mechanism Based on of the Existing Literature, (2024). https://doi.org/10.20944/preprints202403.1661.v2.
[8] M. Carbone, H.I. Pass, L. Miele, M. Bocchetta, New developments about the association of SV40 with human mesothelioma, Oncogene 22 (2003) 5173–5180. https://doi.org/10.1038/sj.onc.1206552.
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[13] EMA, 2020a. Assessment report Comirnaty Common name: COVID-19 mRNA vaccine (nucleosidemodified) [WWW Document]. accessed 3.14.21. https://www.ema.eu ropa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-repo rt_en.pdf., (2021). https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf.
[14] Test Facility Study No. 185350, Sponsor Reference No. ALC-NC-0552, A Tissue Distribution Study of a [ 3 H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats, (n.d.). www.phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf.
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Thanks for this useful summary and collection of references.