Plasmid DNA Contamination: A Primer

Part 1| Investigating the Controversy Behind Pfizer's Vaccine Production Process

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Kevin McKernan, a scientist known for his work in genomics, has been sounding the alarm recently on Pfizer’s controversial vaccine production process, and the failure to disclose manufacturing switches from even regulators, putting our health at risk at warp speed. 

The discourse, which is centered around plasmid DNA contamination, has been significantly driven by a few researchers like McKernan, Geoffrey Norman Pain, Professor Retsef Levi, and Josh Guetzkow. The work also led to the discovery of SV40 sequences within the vaccine. 

The fact that the egregious findings have not made headline news or finally halted production of these shots is beyond me. And while some on social media have recognized the gravitas of these discoveries, the mainstream remains mum. 

I don't know how anyone can still think these shots are safe and effective. They are dangerous and useless and below are more than five reasons as to exactly why.  

Below we will cover:

• Process One

• Process Two

• Antibiotic Resistance Gene

• Increased DNA Length

• Risk of Contamination

• Regulatory and Clinical Trial Concerns

• Immunogenicity Testing

• Elderly Population

• Trial Blinding

• Batch Variability

• Placebo Group

• Lot Numbers and Distribution

• Regulatory and Manufacturing Processes

• Lipid nanoparticles (LNPs)

• SV40 (Simian Virus 40) Promoter

• Open Reading Frames 

• Impact of Modifications

Plasmid DNA In Vats Of E.Coli | Warp Speed Pharamceia 

To gain warp speed and scale up production there were changes made in the manufacturing process of mRNA vaccines between the clinical trial phase and the production phase for widespread distribution. The public wasn’t told. This transition –  termed "process one" and "process two" – raises several issues:

Process One: Initially, PCR (Polymerase Chain Reaction) was used to amplify the DNA segment needed for the "vaccine." This is a standard laboratory technique for making multiple copies of a segment of DNA. The DNA is then transcribed into RNA using an enzyme called RNA polymerase, which was the method reportedly used during the clinical trials.

Process Two: For mass production, the DNA was placed into a plasmid – a small, circular piece of DNA that can replicate within bacteria like E. coli. These plasmids are grown in E. coli bacteria because they can replicate quickly, allowing for the mass production of the DNA that will then be transcribed into mRNA for vaccines. This method is more scalable than PCR because once the plasmid is introduced into the E. coli, the bacteria multiply and amplify the DNA, which can then be harvested in much larger quantities.

Antibiotic Resistance Gene: The plasmid also includes an antibiotic resistance gene which allows for the selection of bacteria that have successfully taken up the plasmid. When grown in the presence of antibiotics, only the bacteria with the plasmid (and therefore the DNA of interest) survive. The risks of just this alone are absolutely incredible. 

Increased DNA Length: With this new process, the DNA used in the vaccine production grew in size due to additional components necessary for plasmid replication in bacteria, which was not the case in the original PCR process used in clinical trials.

DNA in Vaccines| Risk of Contamination: When grown in the presence of antibiotics, only the bacteria with the plasmid (and therefore the DNA of interest) survive. In theory. Extracting DNA from E. coli can introduce contaminants such as endotoxins (e.g. lipopolysaccharide, LPS), especially if the purification process doesn't remove such impurities effectively. The levels of residual DNA may exceed regulatory limits and there is also criticism toward methods used to measure DNA and RNA, suggesting they could misrepresent the true quantities. Adverse reactions like anaphylaxis when injected. You know, like sudden death. 

Additionally, because there are no standards, the variability of endotoxin levels among different batches and its potential impact on adverse events is particularly noteworthy. Let us take note that despite FOIA requests, the endotoxin levels of these jabs were redacted. Moreover, there is the suggestion that the interaction between the spike protein and endotoxin could exacerbate inflammatory responses.  

Note that there now exists data demonstrating the persistence of vaccine mRNA in plasma and breast milk contradicts initial claims about its transient nature. The long-term biological effects of these modified RNAs and any proteins they produce have not been fully explored.

Regulatory and Clinical Trial Concerns: The production process was changed after clinical trials without re-evaluating the vaccine's safety with the new process. How did regulators allow this change in manufacturing without adequately considering the potential increased risk and without requiring new clinical trials to assess the safety of the vaccines produced with the new method? To compare processes one and two, only 252 patients were studied compared to 22000. This sample size is obviously insufficient in detecting adverse events.

What’s worse is that regulatory bodies like the FDA and Health Canada behaved like unresponsive ("crickets") to the findings. It’s convenient to use the “emergency” as the reason why they expedited the deployment of these vaccines during the p*andemic but what is the excuse now for not addressing quality control processes?

Immunogenicity Testing: There are concerns that out of 252 people, only four individuals had their antibody response checked after receiving two doses of the vaccine, and this testing was only done on a younger age group (16-22 years old).

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