FDA Fails To Address DNA Adulteration Concerns

The DNA fragments come from the circular bacterial DNA 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.

Have drug manufacturers evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from the mRNA Covid-19 vaccines alongside the additional risk of DNA integration from the lipid nanoparticle delivery system and SV40 promoter/enhancer? Has FDA inquired any information from the drug manufacturers to investigate such risk?

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.

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.

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.

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 Dr. Marks has failed to cite in his response.

In its response to an appropriate and well-documented inquiry from the Florida Surgeon General, the US FDA has clearly failed to establish that it was aware of the contamination or adulteration of COMIRNATY or SPIKEVAX final drug products with plasmid DNA fragments, and has completely failed to insist on the testing necessary to both establish dose-limiting toxicity of DNA fragments when delivered to animals or humans using these highly active lipid nanoparticle formulations. 

https://brownstone.org/articles/fda-fails-to-address-dna-adulteration-concerns/