Plasmid DNA from Pfizer COVID Vaccine Manufacturing

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In summary, the document discusses the role of plasmid DNA in the manufacturing process of the Pfizer COVID-19 vaccine. It highlights how plasmid DNA serves as a template for producing mRNA, which encodes the spike protein of the SARS-CoV-2 virus, triggering an immune response. The manufacturing process includes steps such as plasmid design, fermentation, purification, and quality control to ensure the plasmid DNA's integrity and effectiveness in vaccine production. The discussion emphasizes the importance of plasmid DNA in enabling rapid vaccine development and production at scale.
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.Scott
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Dr. Buckhault using his own funds and with assistance from USC students and facilities, took advantage of the opportunity to check mRNA vaccine batches for DNA fragments. He found them and his concerns, taken at face value, seem valid and reasonable to me.
Last week, Phillip Buckhaults, PhD addressed the South Carolina Senate on the subject of DNA fragments the USC lab has found in batches of the Pfizer COVID-19 vaccines. Those fragments are from plasmids used by Pfizer in the large-scale manufacturing of their vaccine - but not in the early batches used in their early studies.

His address was about 34 minutes in length and is included in a "News Break" news article.

His study was ad hoc and he does not believe his finding rise to the quality level of peer-review publication.

Dr. Buckhaults is a professor at the University of South Carolina. His lab research has focused on "Determining biochemical mechanisms by which germline variants contribute to cancer health disparities that exist between people of different ethnic ancestries" and "Using genome sequencing and functional genomics to develop novel personalized medicine approaches to treat colon cancer".

He said that the DNA levels in the Pfizer vaccine batches are near the regulatory limit - in some batches a bit over. But the DNA is encapsulated in lipids and those limits are not appropriately addressed in the FD regulations. He also found DNA in the Moderna vaccine, but at lower levels.

His conclusions (from his PowerPoint):
We should check a bunch of vaccinated people to see if plasmid DNA has integrated into their genomic DNA.
We (you [government]) should insist that the USFDA force Pfizer to get the DNA out of the booster and all future mRNA based vaccines.
The regulation that allowed the DNA to be there should be changed. It's a leftover from previous vaccines that contained only naked DNA. The mRNA vaccines have this DNA encapsulated in a lipid nanoparticle delivery system (trojan horse) and so the DNA is a far more serious issue.
...

I very much expect that this will become an unavoidable public conversation.
Although Dr. Buckhaults is supportive of COVID vaccination, and expressed his support in his address, I have already seen postings that are using his address to argue against the programs - in terms we are probably all well-familiar with.
 
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  • #2
We were having a brief conversation about this earlier this week. It's definitely fuel for any anti vaxxers to get carried away with until more information is determined.

Meanwhile, while it gave excuse for a few to complain about why their own (intentional) transfections weren't working lol.
 
  • #4

FAQ: Plasmid DNA from Pfizer COVID Vaccine Manufacturing

What is plasmid DNA and why is it used in the Pfizer COVID vaccine manufacturing process?

Plasmid DNA is a small, circular piece of DNA that can replicate independently of chromosomal DNA. In the Pfizer COVID vaccine manufacturing process, plasmid DNA is used as a template to produce the mRNA that encodes the spike protein of the SARS-CoV-2 virus. This mRNA is then encapsulated in lipid nanoparticles to form the vaccine.

How is plasmid DNA produced for the Pfizer COVID vaccine?

Plasmid DNA is produced using bacterial fermentation. Bacteria, usually E. coli, are transformed with a plasmid containing the gene of interest. These bacteria are then cultured in large fermenters where they replicate and produce large quantities of the plasmid DNA. The plasmid DNA is then extracted and purified for use in the vaccine manufacturing process.

Is the plasmid DNA used in the Pfizer COVID vaccine manufacturing process safe?

Yes, the plasmid DNA used in the Pfizer COVID vaccine manufacturing process is considered safe. It is highly purified and undergoes rigorous quality control tests to ensure it meets safety and efficacy standards. Additionally, the plasmid DNA itself is not part of the final vaccine product; it is used only as a template to produce the mRNA.

How is the plasmid DNA removed from the final Pfizer COVID vaccine product?

During the manufacturing process, the plasmid DNA is used to produce mRNA through transcription. After the mRNA is synthesized, the plasmid DNA is removed through a series of purification steps. The final vaccine product contains only the mRNA encapsulated in lipid nanoparticles, with no residual plasmid DNA.

What quality control measures are in place to ensure the plasmid DNA used in the Pfizer COVID vaccine is pure and effective?

Several quality control measures are in place to ensure the purity and efficacy of the plasmid DNA used in the Pfizer COVID vaccine. These include stringent testing for contaminants, verification of the plasmid sequence, and assessment of the plasmid's ability to produce the desired mRNA. Additionally, the entire manufacturing process is conducted under Good Manufacturing Practices (GMP) to ensure high standards of quality and safety.

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