(LifeSite) The failure of government regulatory authorities to identify and disclose DNA fragment contamination of the Moderna and Pfizer/BioNTech COVID vaccine products prior to independent laboratories disclosing their contamination study findings has raised serious questions about quality control oversight of the manufacturing processes used to produce these products, as well as their overall safety.
Rather than rigorously addressing specific safety questions concerning the previously undisclosed contamination or adulteration of both modified-mRNA vaccines, in a written December 14 reply to a prior December 6 inquiry, Dr. Peter Marks of the FDA Center for Biologics Evaluation and Research has resorted to redirecting, gaslighting, and stonewalling the surgeon general of the state of Florida.
Marks (a hematologist and oncologist), together with the U.S. government biowarfare specialist Dr. Robert Kadlec, was responsible for initial creation and regulatory management oversight of Operation Warp Speed, is very invested in the success of this program, and has proposed that it be expanded to include cancer treatments. Operation Warp Speed exploited the special U.S. Emergency Use Authorization regulatory pathway to bypass many of the regulatory steps and procedures normally required to ensure the safety and effectiveness of vaccine products, which typically require up to a decade of development before widespread deployment.
Worldwide administration of the resulting injectable products has been associated with over seventeen million excess deaths (globally), as well as large numbers of cases of heart damage (myocarditis) with a perverse predilection for young people, contradicting the repeated propaganda statement that these products are safe. U.S. government officials have colluded in a widespread campaign to cover up data concerning myocarditis side effects. There are over 700 peer reviewed academic publications documenting these and many other types of damages and illnesses caused by these products.
In one of the most intensive global propaganda and marketing campaigns ever deployed, it has been widely asserted that these products will enable herd immunity, will prevent infection, replication, and spread of SARS-CoV-2, and will also prevent COVID-19 disease and death. However, it is now widely recognized that these mod-mRNA provide none of these benefits and are therefore not effective. The messaging used in this propaganda campaign has been supported by over 1,200 peer reviewed academic publications providing propagandists and marketing specialists advice on how to overcome “vaccine hesitancy.”
Despite the proven and documented lack of safety and effectiveness, overlapping layers of legal protection (indemnification) prevent both deceived public and damaged individuals from obtaining compensation for this fraud.
In his response to the surgeon general’s questions, Marks has provided a series of unsupported or misleading statements, combined with circuitous and not scientifically rigorous responses to the specific questions posed. These responses appear to suggest that the FDA has failed to require DNA integration studies to determine the dose limiting toxicity of bacterial plasmid DNA fragments when delivered into animal models using the specific formulations now injected into over a billion human beings. Marks failed to cite any studies which specifically address DNA fragment integration risks to those receiving these products, instead referring only to studies which can only detect other types of genotoxicity. DNA fragment integration is one of multiple types of genetic damage which such lipid nanoparticle formulations may cause.
In his response to Ladapo’s inquiry, Marks cites an FDA guidance document which addresses general requirements for assessing DNA contamination of vaccines (such as influenza) which are manufactured using cultured cell lines. This type of manufacturing process often yields vaccine material which is contaminated with large fragments of chromosomal DNA from the animal cells used to grow the vaccine.
This contamination is substantially different from that involving the mod-mRNA products, in that we now know that those products are contaminated with small DNA fragments which are more likely to cross into the region of cells which contain the genome, and in contrast to traditional vaccines these mod-mRNA products and their DNA contaminants are assembled into highly active lipid nanoparticle delivery formulations, greatly increasing the risk that such DNA will enter both the cells and the part of the cells which house the genome (the nucleus).
Despite the fact that the risks of DNA contamination with traditional cell-based vaccines are much lower than for the novel mod-mRNA lipid nanoparticle-based products, the cited FDA guidance documents include the following specific warnings concerning DNA contamination:
Residual DNA might be a risk to your final product because of oncogenic and/or infectivity potential. There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.
In his response to the surgeon general, Marks refers to a specific clause in this guidance to support safety of the levels of DNA fragment contamination, which in turn refers back to a WHO document. What he fails to acknowledge is that this guidance refers to DNA contamination in a directly injected (parenteral) vaccine, not one employing the most highly active DNA and RNA lipid nanoparticle delivery system ever devised by man. This oversight either reveals Marks’ profound ignorance of this significant difference (despite the surgeon general having pointed this out in his initial letter), or a fraudulent attempt to gaslight and obfuscate the truth of the matter. Either ignorance or intentional cover up, hard to differentiate. Here is the cited clause:
You should limit residual DNA for continuous non-tumorigenic cells, such as low-passage Vero cells, to less than 10 ng/dose for parenteral inoculation as recommended by WHO (Ref. 31)
Reference 31 refers to a WHO document developed and published in 1998, less than a decade after my initial discoveries relating to large scale mRNA manufacture and delivery and about the same time as Kariko and Weissman’s first report of their work with pseudouridine. This outdated WHO statement predates the development of the current generation of mod-mRNA delivery technology by approximately 20 years, and is completely irrelevant.
In additional efforts to cover up the apparent failure of the FDA to require the specific DNA integration toxicology studies both logically needed to rigorously assess patient risk and required for all previous DNA vaccine products prior to human experimental use, Marks cites the summary approval document for the Pfizer/BioNTech mod-mRNA product “Comirnaty” as well as the summary approval document for the Moderna “Spikevax” product. Specifically, Marks makes the following assertion:
… studies have been conducted in animals using the modified mRNA and lipid nanoparticle together that constitute the vaccine, including the minute quantities of residual DNA fragments left over after DNAse treatment during manufacturing, and demonstrate no evidence for genotoxicity from the vaccine.
The very limited studies performed are incapable of detecting DNA fragment integration. Once again, this statement reflects either intentional gaslighting or incompetence. The Comirnaty document provides no specific references to genotoxicity or integration studies having been performed prior to human authorization. In contrast, the Spikevax document (Spikevax is not the same product as Comirnaty) lists the following assays performed:
Under the heading “Other Supportive Toxicology Studies,” this regulatory submission demonstrates the gross inadequacy of the testing performed for Spikevax which, despite this inadequacy, apparently still exceeds the testing performed for Comirnaty. The Spikevax documentation refers to an in vitro (ergo in a test tube) rat micronucleus assay of the formulated mRNA. No mention is made of any level of DNA fragment contamination in the tested preparation.
The in vitro rat micronucleus assay is a method for rapidly testing the activity of a pharmaceutical or radiologic treatment in grossly disrupting chromosomes. It is completely inappropriate and incapable of detecting insertional mutagenesis. PEG2000-DMG is one of many components of the lipid nanoparticle, and these test results are irrelevant to the questions raised by the surgeon general, as neither mod-mRNA nor DNA fragments were tested, and once again the tests performed would fail to detect any integration events.
The appropriate testing for DNA fragment integration is covered in the FDA guidance document “Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications,” which Marks has failed to cite in his response. Marks makes the following assertion in his response to the surgeon general:
On first principle, it is quite implausible that the residual small DNA fragments located in the cytosol could find their way into the nucleus through the nuclear membrane present in intact cells and then be incorporated into chromosomal DNA.
Once again, at best this statement reveals Marks’ profound ignorance. The use of this type of lipid nanoparticle technology for delivering both large and small DNA fragments into the nucleus of cultured cells is industry standard, and has been for decades. This statement is also directly contradicted by the guidance cited above, which states the following:
