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1. Residual DNA is present: To make the modified mRNA (mod mRNA) both the Moderna and Pfizer/BioNTech products used a bacterial plasmid as their template. This bacterial DNA should be removed during the manufacturing process. However, DNA fragments of various sizes originating from the plasmids have been found in the COVID-19 genetic vaccine vials and confirmed to be contained within the Lipid Nanoparticles (LNPs). Studies confirming the presence of bacterial DNA have been replicated by a number of international researchers. Residual DNA levels exceed the maximum acceptable levels, depending on the analytical method used, as outlined by the World Health Organization. Any materials within the LNPs are protected from degradation and have potential to transfect (or enter) the cells.
2. Presence of the SV40 promoter-enhancer sequence: The SV40 sequence was part of the plasmid DNA used to create the mod mRNA for the Pfizer/BioNTech products. This was not disclosed to international regulatory bodies, as was required. The SV40 enhancer is used in gene therapy research to facilitate the entry of DNA into a cell's nucleus and integrate that DNA into the genome (human DNA). The SV40 promoter can integrate into the cellular DNA and disrupt the regulation of genes like the p53 tumor suppressor gene. The p53 tumor suppressor gene is one of our body’s safeguards against the development of cancer. Both the SV40 promoter and enhancer DNA sequences have been found in all the Pfizer/BioNTech vials tested to date.
3. Biodistribution: Contrary to the claims of government and public health officials, the COVID-19 genetic vaccines do not remain in the arm and its draining lymph nodes. The Lipid Nanoparticles deliver their contents to various organs throughout the body, and Kammerer et al. have confirmed that spike protein may be further dispersed via exosomes from the cells in which they are produced; this may explain the ‘shedding’ phenomenon. Manufacturers have not definitively determined in what specific organs or tissues the spike protein is produced or distributed in the body; nor have they definitively defined what quantity of spike protein produced.
4. Potential Prolonged Spike Protein Production: The mRNA in the COVID-19 genetic vaccines is called modified because its natural uridines were replaced with synthetic N1-methylpseudouridine. Uridines are one of the nucleic acids used as building blocks for mRNA. This substitution was made to delay the degradation of the mRNA, increase spike protein production, and theoretically, the immune response. However, manufacturers have failed to define the length of time the spike protein is produced in the body with each injection and the length of time the before the mRNA itself is degraded.
5. Potential production of undetermined proteins with unknown clinical implications: The use of synthetic N1-methylpseudouridine also introduces the possibility of 'ribosomal frameshifting'. Rather than reading every nucleic acid in sequence to create a new protein, ribosomal frameshifting causes the skipping of nucleic acids. Like skipping words in a sentence, the end result is nonsense or something completely unintended. In this case, frameshifting may lead to the production of new proteins with unknown impacts on human health, including autoimmunity or prion disease.
6. Immune Tolerance: Repeated exposure to foreign protein is known to potentially cause our bodies to stop generating an immune response to it. This is the risk of repeated exposure to the spike protein and would be one explanation for people becoming more susceptible to worsening disease from SARS-CoV-2 infection after receiving multiple COVID-19 genetic vaccine doses.
7. IgG4 Predominance: Researchers have found a shift in the types of immunoglobulins produced by people who have received multiple injections. This shift to predominantly IgG class 4 antibodies is in part responsible for immune tolerance, but may also be associated with chronic inflammation and a group of conditions known as 'IgG4-related' diseases.
8. Other regulatory approval issues: The mod mRNA products were classified as vaccines for their regulatory approval, but they work in the human body (their mechanism of action) like a gene therapy. In fact, these products satisfy the FDA's definition of a gene therapy. Their safety should have been assessed by their mechanism of action within the body. For this reason, manufacturers did not have to complete a number of regulatory requirements that are normally applied to gene or even drug therapies such as safety pharmacology, drug interactions, “shedding”, genotoxicity and carcinogenicity studies. In addition, there was a failure to adequately determine potential adverse events because inappropriate animal models were used for the nonclinical trials.
9. Loss of potential effectiveness and long-term safety data: By unblinding the clinical trials after a few months, the opportunity to definitively determine effectiveness and long-term safety through a randomized control trial was lost. This makes it difficult to determine adverse events from the vaccine from those potentially caused by the virus itself.
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