DNA Integration Risk: Moderna knows, FDA denies

modified-mRNA Vaccines are Adulterated with DNA fragments, and FDA is stonewalling

Both Moderna and Pfizer/BioNTech SARS-CoV-2 vaccines are contaminated with plasmid DNA fragments which have not been removed during the current manufacturing processes. This proven fact has been acknowledged by the US FDA, Health Canada, and the European Medicines Agency. In yet another clear breach of informed consent and labeling requirements, this was not previously disclosed to physicians, public health officials, or patients. Furthermore, the presence of highly active promoter/enhancer DNA sequences (and fragments) derived from the SV40 virus, present in the Pfizer/BioNTech product, was not disclosed and discussed with either the public or to the regulatory agencies. This has also been clearly established. Prior FDA guidance concerning the closely related DNA vaccine technology cited the presence of such highly active regulatory sequences as being of particular concern due to potential insertional mutagenesis (integration).

Despite these facts, and contrary to both federal law (21 U.S. Code § 351 - Adulterated drugs and devices) and established FDA guidance (CPG Sec. 420.100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act. *Direct Reference Seizure Authority for Adulterated Drugs Under Section 501(b)*), in response to reporter questioning regarding this issue, the FDA has issued a categorical denial of adulteration and risk, stating that “no safety concerns related to the sequence of, or amount of, residual DNA have been identified.”

The claim that the FDA is required to take any of the authorized or approved mRNA COVID-19 vaccines off the market is false. With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified. With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective.

At best, this is willful blindness. As previously discussed at length (with peer reviewed references), such short DNA fragments (including “oligonucleotides”) are associated with a high risk of integration, otherwise known as insertional mutagenesis, which is a well characterized form of genotoxicity. If these “vaccines” were reviewed by FDA as gene therapy products, which in fact they are gene therapy technology employed for the purpose of eliciting an adaptive immune response against an encoded antigen, rigorous genotoxicity (including insertional mutagenesis) studies would have been required prior to use in humans. If these were “DNA vaccines” rather than modified-mRNA vaccines, rigorous genotoxicity (including insertional mutagenesis) studies would also have been required prior to use in humans. But apparently there is something magical about inclusion of modified-mRNA together with DNA fragments in these highly active lipid nanoparticle nucleic acid delivery formulations which leads the FDA to conclude that there is no genotoxicity risk.

Of note is that there is no documentation of DNA fragment genotoxicity studies having been performed by Pfizer/BioNTech or Moderna or FDA itself to assess the risk profile of these highly active non-viral delivery formulations when co-formulated with both modified mRNA and DNA fragments. Clearly, given the established scientific literature and prior established regulatory precedent involving DNA vaccine insertional mutagenesis/integration risk, a prudent and proactive regulatory authority would have developed data to support a data-based threshold for DNA fragment contamination. But by all appearances, no such data are available. The most well-documented risks associated with such potential insertional mutagenesis are cancer (in the case of stem and somatic cells, particularly hematopoietic lineage cells) and birth defects. As these highly active modified mRNA (plus DNA fragment) lipid nanoparticles are known to cross the placenta and to localize to ovarian tissue, the potential for birth defects would seem to be of particular regulatory interest and concern.

However, despite global reports of unusually aggressive cancers (high mitotic rates and unusually rapid clinical progression) arising in patients administered these products, and the established fact that the CDC VAERS system does not support capturing longer term safety data on these products, the FDA remains willfully ignorant and in denial of these risks. Furthermore, despite the repeated propaganda line of “safe and effective”, the FDA refuses to qualify these subjective terms. What is actually meant by “safe”? For products which do not prevent infection, replication, or spread of SARS-CoV-2 virus? And which do not prevent severe clinical illness or death from COVID disease? And for which the currently dominant circulating HV.1 (pango designation) SARS-CoV-2 strain is almost completely resistant to neutralization by antibodies elicited after administering the currently approved “booster” vaccine? Previously, with disease associated with certain SARS-CoV-2 strains, the FDA and CDC have asserted that prior versions of the modified mRNA/DNA fragment vaccines reduce risks of severe disease or death, but those assertions (whether true or artifactual) are now irrelevant as those “vaccine” products are no longer available, and those viral strains are extinct. Furthermore, many researchers have demonstrated that, even in those historic cases, after some period of time those so dosed with these products become MORE likely to develop severe disease or death relative to unvaccinated patients (most of whom have acquired natural infection with resulting potent and diversified immunity.

Despite these well established facts, the FDA continues to substitute hope for data, willful ignorance for careful risk analysis, and issues what can only be regarded as propaganda regarding both the safety and effectiveness of these products.

Unfortunately for the FDA, the modified mRNA manufacturer Moderna clearly acknowledges the risks of genotoxicity associated with delivered DNA. In the issued US Patent #US2019/0240317 A1 (see image above) titled “HPIV3 Vaccines”, Moderna provides the following text:

[0012] Deoxyribonucleic acid (DNA) vaccination is one technique used to stimulate humoral and cellular immune responses to foreign antigens, such as hMPV antigens and/or PIV antigens and/or RSV antigens. The direct injection of genetically engineered DNA ( e.g., naked plasmid DNA) into a living host results in a small number of its cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.

Note that Moderna considers even “naked” plasmid DNA (with no added highly active lipid nanoparticle formulation agents) to place patients at risk of insertional mutagenesis, and associated cancer risk (ergo “activation of oncogenes or the inhibition of tumor suppressor genes”). Precisely the integration and genotoxicity risks which I previously highlighted. No surprise, as these are risks which I identified as providing the most compelling support for the use of mRNA for vaccines and genetic medicines in my original patent disclosures and subsequent issued patents from the late 1980s.

Moderna further elaborates on these risks in the summary statement for this patent.

SUMMARY

[0013] Provided herein are ribonucleic acid (RNA) vaccines that build on the knowledge that RNA ( e.g., messenger RNA (mRNA)) can safely direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. The RNA (e.g., mRNA) vaccines of the present disclosure may be used to induce a balanced immune response against hMPV, PIV, RSV, MeV, and/or BetaCoV (e.g., MERS-CoV, SARS-CoV, HCoV-OC43, HCoV-229E, HCoV-NL63, HCoV-NL, HCoV-NH and/or HCoV-HKUl), or any combination of two or more of the foregoing viruses, comprising both cellular and humoral immunity, without risking the possibility of insertional mutagenesis, for example. hMPV, PIV, RSV, MeV, BetaCoV (e.g., MERSCoV, SARS-CoV, HCoV-OC43, HCoV-229E, HCoV-NL63, HCoV-NL, HCoV-NH and HCoV-HKUl) and combinations thereof are referred to herein as "respiratory viruses." Thus, the term "respiratory virus RNA vaccines" encompasses hMPV RNA vaccines, PIV RNA vaccines, RSV RNA vaccines, MeV RNA vaccines, BetaCoV RNA vaccines, and any combination of two or more of hMPV RNA vaccines, PIV RNA vaccines, RSV RNA vaccines, MeV RNA vaccines, and BetaCoV RNA vaccines.

Of course, what Moderna does not disclose in this patent application is that they have not been able to reduce to practice the manufacturing of such modified mRNA vaccines without contaminating DNA, making these claims regarding this specific advantage largely irrelevant.

What is abundantly clear from these documents and those previously cited is that the public has been placed at increased risk of genotoxicity, insertional mutagenesis, and cancer by the contaminant and/or adulterants now discovered and confirmed to be present in the modified mRNA COVID vaccines produced by Pfizer/BioNTech and Moderna. It is also clear that Moderna is explicitly aware of these risks, yet apparently did not disclose nor discuss them in their regulatory submissions to FDA, Health Canada, or the European Medicines Agency. It is also clear from prior correspondence with the European Medicines Agency and Health Canada that the presence and risks associated with the SV40 highly active regulatory sequences were not adequately and transparently presented to and discussed by Pfizer/BioNTech with any of these three agencies.

In conclusion, it is also clear at this point, unless proven otherwise, that none of these regulatory authorities have obtained data from one or more rigorous, well controlled studies designed to address the genotoxicity and insertional mutagenesis risks associated with different levels of DNA fragment contamination/adulteration of the specific modified mRNA vaccine non-viral delivery formulations employed with either the Moderna or Pfizer/BioNTech COVID “vaccine” products. Therefore, until such time as data from such well-controlled studies are produced and objectively peer-reviewed, vague statements such as “no safety concerns related to the sequence of, or amount of, residual DNA have been identified.” do not accurately reflect current knowledge.

Given prior research findings as well as regulatory precedents, the only objective conclusion to be made concerning such statements is that they functionally represent propaganda rather than proven scientific and regulatory fact.

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