https://rwmalonemd.substack.com/p/fda-fails-to-address-dna-adulteration

Excerpt from r/DebateVaccines:

https://www.reddit.com/r/DebateVaccines/comments/18k1lza/fda_fails_to_address_dna_adulteration_concerns/

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 Dec 14 reply to a prior Dec 06 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.

Experts from around the world have raised concerns about the safety implications of DNA fragment contamination in COVID gene therapy-based “vaccine” products. Leading regulatory authorities have conceded that these rushed novel and complex biological products are contaminated, and deliver both synthetic modified messenger ribonucleic acid (mod-mRNA) and a wide variety of uncharacterized shorter DNA fragments into the cells and tissues of those who have accepted these product. The Biden administration has previously mandated and currently markets these products in the USA for Americans of all ages including during pregnancy, fraudulently claiming that they prevent SARS-CoV-2 infection and spread as well as COVID-19 disease and death.

These DNA fragments are left over contaminants from manufacturing the mod-mRNA “payload”. The contamination was first detected and reported by experienced US and Canadian genomic researchers, and their findings have been replicated by many other laboratories.

To manufacture the COVID shots, both the DNA contaminants and the mod-mRNA are assembled into the most highly active lipid nanoparticle genetic delivery system ever developed, and this final drug product has been injected into over a billion human arms. After injection, the material distributes throughout the body and delivers both DNA and mod-mRNA to a wide variety of cells and tissues including ovaries. Both mRNA and DNA can control a wide variety of cell functions. The mod-mRNA directs cells and tissues of the recipient to produce genetically engineered SARS-CoV-2 spike protein (as well as other uncharacterized “frameshifted” proteins and peptides). The DNA fragments come from the circular bacterial DNA (“plasmids”) used to manufacture the mod-mRNA. These plasmids include DNA sequences which can produce a variety of functions inside both bacterial and human cells; proteins which confer antibiotic resistance, sequences which guide DNA into the nucleus of cells, and highly active genetic switches for turning on adjacent genes in either bacterial or animal cells.

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In his response to the Surgeon General’s questions, Dr. 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. Dr. 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 Dr. Ladapo’s inquiry, Dr. 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, Dr. 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 Dr. 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, Dr. 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, Dr. 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 compon

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