Bacterial DNA Contamination of the COVID19 modRNA Gene Therapy Products (GTPs) And Why It Matters.
Here we take a deep look into this matter.
https://overallscience.com/plasmids-and-its-types/#google_vignette
Dr. Joshua Lederberg coined the term “plasmid” in this article from 1952. He had observed that bacteria were able to transfer packets of DNA containing the gene for antibiotic resistance as an example. Lederberg and plasmids
The National Library of Medicine has a web site devoted to Dr. Lederberg and his research group at the University of Wisconsin and later at Stanford University. Dr. Lederberg shared the 1958 Nobel Prize in Physiology and Medicine with two others for this work.
Their most important discoveries were that of transduction--the transfer of genetic fragments from one cell to another by a virus--and of extra-chromosomal genetic particles called plasmids. Lederberg has invoked the excitement and enduring mysteries of the field at the time: "We were exploring a completely new territory that we only dimly understood. We weren't looking for transduction--we bumped into it. We weren't looking for plasmids--we bumped into them. Every time we turned around we found something unexpected."
The schematic above represents a bacterial cell on the left with a plasmid inside on the left and next to it the bacterial DNA on the right.
The expanded view on the right is a map of the plasmid DNA with various components that control insertion into a host genome. Plasmid science has advanced considerably since Dr. Lederberg’s time becoming a valuable method for synthesis of biologic drugs.
The Pfizer Phase 2/3 trial C4561001 used a polymerase chain reaction (PCR = Process 1) technology in the ~20,000 subjects in the active limb of the trial but switched to a bacteria based technology for mass production (E. coli plasmid DNA = Process 2).
During preclinical testing and clinical trials of the modRNA family of products it was clear that the biologic activity of the different preparations varied. Yet the testing of the Process 2 GTP was even less than the Process 1 GTP; no animal studies and a brief clinical trial involving a tiny sample of 252 subjects. Thus, neither the Process 1 GTP nor the Process 2 GTP was adequately analyzed and tested.
What follows an detailed explanation of the two processes involved in producing modRNA GTPs from “Dig Deeply” followed by a review of the significance of Process 2.
Dig Deeply’s review of the Two Processes
From the author:
“This paper aims to build a bridge between the highly specialized scientific explanations in the specialist literature and the generally understandable descriptions in the media. By conveying detailed knowledge on the topic of ‘foreign DNA in vaccines’, the goal is to help make complex processes understandable to a broader audience.”
Definitions of terms used in the following document may be helpful.
https://en.wikipedia.org/wiki/Glossary_of_cellular_and_molecular_biology_(0%E2%80%93L)
https://en.wikipedia.org/wiki/Glossary_of_cellular_and_molecular_biology_(M%E2%80%93Z)#Z
Bacterial DNA contamination of C19 GTPs (Link provided with permission from the author)
https://dig-deeply.com/2024/03/15/foreign-dna-in-the-mrna-vaccine/
Discovery of Process 2
Discovery of Process 2 is credited to Josh Guetzkow and Retzef Levi. Guetzkow and Levi BMJ Letter 2022
An October 2020 amendment to the protocol of the pivotal Pfizer/BioNTech BNT162b2 (Comirnaty) clinical trial (C4591001) indicates that nearly all vaccine doses used in the trial came from ‘clinical batches’ manufactured using what is referred to as ‘Process 1’. However, in order to upscale production for large-scale distribution of ‘emergency supply’ after authorization, a new method was developed, ‘Process 2’. The differences include changes to the DNA template used to transcribe the RNA and the purification phase, as well as the manufacturing process of the lipid nanoparticles. Notably, ‘Process 2’ batches were shown to have substantially lower mRNA integrity.
Chris Flowers, Erica Delph and Ed Clark analyzed the small group of Process 2 subjects and found 2.4 times more Adverse Events in the Process 2 active group than the “placebo” group. Flowers et al. Arm pain was high on the list. They concluded,
The process tested and approved was never publicly rolled out and given to the population of the world. Instead, the public only received the DNA plasmid tainted Process 2 product.
Since the follow up period was so brief the significance of the arm pain in these subjects is unknown. Such complaints are often categorized as “Reactogenicity” a term meant to lead to dismissal of the arm pain, fever, and other seemingly “minor” complaints but in reality such symptoms and signs may foretell more significant medical problems such as myositis and rhabdomyolysis.
The preclinical studies done on Process 1 modRNA GTPs were not done for Process 2.
The randomized, double blind controlled trial was to be continued for two years but was terminated after a few months thus destroying the best tool to understand the complications from this experimental, never before used, gene therapy platform.
Dr. Kevin McKernan discovers E. coli plasmid DNA in the vials of modRNA
Analyzing the contents of both mRNA1273 and BNT162b2 vials, Dr. Kevin McKernan reported his findings of bacterial DNA contained in the vials in a series of articles on his substack, Nepalactone Newsletter, beginning in February of 2023. E. coli Bacterial DNA in modRNA Injections
More recently, Dr. McKernan has found evidence that bacterial DNA from the GTP products can integrate into human DNA in cancer cells in tissue culture.
McKernan and E. coli DNA Plasmids
Summary from Camilla
Feb 25·edited Feb 25
“Here is a layman’s summary from Dr Speicher: ‘Despite what Health Canada and the FDA claim integration of the plasmid DNA fragments from the Pfizer COVID-19 vaccine CAN integrate into the human genome. Here's the proof that this can and will happen, at least in cancerous cells. There are 2 confirmed integration events in OvCar3 cancer cell lines in Chr12 intron 11 (FAIM2-205) and Chr9 centromere……Kevin only looked for the integration of the spike gene, but who knows how many other fragments have been integrated. This could be the reason that turbo cancer is on the rise. The only caveat is that cancer cell lines do no (sic) act like normal primary cell lines and frequently have integration events. We need to see the effect of the vaccine on primary cells.’”Summary from Camilla
From the author Anandamide (McKernan)
“These are putative integrations. We need long read confirmation. We did look for regions outside of spike but only had single read evidence. Deeper sequence may reveal more of these. The Mito and Poly A sequences in the plasmid are integration blind spots.”
Not only is the high concentration of bacterial DNA included in the modRNA Process 2 version given to billions of people but there is evidence that not only does the bacterial DNA enter human cells in cell culture but it incorporates into the host (human) genome. The significance of these findings is not yet known.
Dr. Philip Buckaults of the University of South Carolina is now searching for incorporation of bacterial DNA in recipients of the mRNA products.
"People will disagree on the magnitude of the risk. We do not yet know if it means anything or not. There's a chance that this DNA does nothing," he explained.
But he cautioned that "there is a reasonable chance that if you inject pieces of DNA that are wrapped up in this transfection particle—the lipid nanoparticles—there is a reasonable chance that some of this is going to get into cells, and then integrate into the genome of cells. I think we should check and find out."