Covid mRNA Vaccines Contaminated by Mystery DNAs

Written by Allison Krug, Dr. Ram Duriseti, Xiaoxu Sean Lin and Yuhong Dong on October 13, 2023. Posted in Current News

Double-stranded DNA contamination, integration, and migration?

In this series, “Promise or Peril: Alarming COVID-19 mRNA Vaccine Issues,” we explore how the introduction of mRNA technology lacked an adequate regulatory framework, setting the stage for three major issues:

1) inadequate safety testing of lipid nanoparticles,

2) serious adverse events related to the spike protein, and

3) residual DNA- and lipid-related impurities, as well as truncated/modified mRNA species.

Are the vaccines more contaminated than our regulatory agencies realize? Should this raise concerns about migration to the gut or their expression by cells?

Summary of Key Facts

• Concerns have been raised about DNA contamination in the mRNA COVID-19 vaccines. The specific concern is the presence of higher than expected residual DNA plasmids used in the original mRNA production. Independent investigations suggest that the Pfizer mRNA vaccine may have high levels of DNA contamination, potentially exceeding regulatory limits.
• There are theoretical risks associated with plasmid DNA expression and migration to the gut, which could affect human health and the microbiome. Additionally, concerns have been raised about the quality control and manufacturing oversight of mRNA vaccines.
• The European Medicines Agency (EMA), Europe’s drug regulatory authority, noted the presence of truncated and modified RNA as impurities in the mRNA COVID-19 vaccines, raising the need for oversight.
• Related to the manufacturing process, a Danish study compared the rate of adverse events to the batch size (number of doses in a batch) and found a correlation.

The Advisory Committee on Immunization Practices met last week to recommend the updated COVID-19 vaccine. (pdf) However, the manufacturers presented little data from testing in humans. Moderna was the only manufacturer to present safety and antibody response data from experience with 101 individuals.

Pfizer presented antibody response data from 20 mice and is currently collecting data from 400 individuals in clinical testing. No data on manufacturing oversight was presented during the meeting.

As part of the safety evaluation of drug approval, the CMC process (chemistry, manufacturing, and controls) becomes critical in identifying and eliminating impurities. It sets strict standards and product specifications to maintain the purity of each batch.

Compliance with these standards is essential for obtaining approval from global health authorities.

Imagine you are a coffee drinker, and you decide to buy a bag of premium, freshly ground coffee beans from your favorite store. You expect that each bag contains pure, high-quality coffee grounds to brew that perfect cup of coffee.

However, when you open the bag, you discover that it’s not just coffee grounds; it also contains a mixture of sand and other foreign particles. This unexpected impurity completely ruins your experience.

Just as you rely on the purity of your coffee grounds for a great cup of coffee, the pharmaceutical industry, including vaccine production, has regulations in place to ensure good manufacturing practices. Patients and consumers expect that these guidelines mean drug or vaccine formulations are free from unwanted substances, ensuring their safety and effectiveness.

A plasmid appears like a tiny micro-bracelet with different segments representing different pieces of genes.

It is also unclear whether the plasmids can merge with human genes within the cell or travel to the gut.

The DNA must be removed from the final product before distribution, but some residual amount is expected to remain. Unanswered questions include:

How much DNA is in the vials?

Is it over the limit?

Is the FDA tracking this?

And what are the implications, if any, with regard to persistence in the recipient?

There are at least two independent groups of investigators who have conducted lab tests and confirmed the mRNA vaccine of Pfizer has been contaminated by DNA.

The batches examined, provided by an anonymous source, were unopened, expired vials that were not delivered on dry ice. If these data hold, the actual amount of plasmids was 18 to 70 times higher than the EMA limit. (Table 3, page 12.)

Obviously, future investigations should attempt to establish contamination levels using unexpired doses with an intact cold chain.

Professor Phillip Buckhaults, who holds a doctorate in biochemistry and molecular biology and is considered an expert in cancer genomics research at the University of South Carolina, performed an independent analysis for the presence of DNA in Pfizer batches.

Plasmids help produce the DNA by splicing in the desired sequence into a bacterial plasmid (Figure 1).

Then workhorse bacteria, often E. coli, help spin out the DNA for production. These bacteria have an extra burden: They must replicate not only their own genome but also the plasmid DNA inserted within their genome.

This takes slightly more time, so the bacteria without the additional DNA will eventually outcompete those with the DNA.

This selective elimination allows the plasmid-carrying antibiotic-resistant bacteria to continue growing. In other words, this antibiotic resistance gene confers an advantage that drives selection pressure to favor the bacteria producing the desired DNA.

Diseases, including obesity, diabetes, cardiovascular disorders, cancer, hypertension, and irritable bowel syndrome have been loosely linked with disturbances of the gut microbiome.

The agency noted that the impurities were found at different levels during production. For instance, levels may be higher in smaller test batches than in larger commercial batches.

While this finding is intriguing, the authors call for more research to see if this is a consistent pattern. We reviewed the raw data provided by the authors and agree that a clustering of AEs seems to be found with batches having fewer than 100,000 doses.

Thus far, there is no evidence that a reverse-transcribed DNA product can merge with a human cell’s genome. Claims about integration are solely speculative and based upon an evolutionary precedent for such a process.

The EMA asked for additional testing but allowed distribution to go forward. The scientists believed these fragments were unlikely to be intact mRNA fragments. An intact mRNA fragment needs to have a cap and a tail. The cap and tail are needed to tell the cell when to start and stop producing the spike protein.

Nevertheless, the EMA requested additional reports. The agency was concerned that an autoimmune reaction could be triggered if fragments’ potentially encoded proteins resemble human proteins.

In other words, if the fragments “mimic” human proteins, antibodies could be developed against our own bodies.

“Any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process should be evaluated. Due date: July 2021. Interim reports: March 2021, and on a monthly basis,” the EMA stated.

For instance, The Epoch Times has previously investigated the link between quality issues and clotting risk (Part 1, Part 2, and Part 4).

This issue of contamination by DNA and mRNA fragments should also be explored further to understand whether certain lots were affected more than others. We also need to know whether DNA contamination is linked to adverse events. The EMA should strictly follow its monitoring standards.

The issue of having any DNA contamination is biologically unavoidable given that the mRNA is transcribed from DNA vectors. The potential issue here is the unusually high level of DNA contamination involved in the mRNA vaccines.

However, pivoting these RNA therapeutics to a vaccine platform in the context of a lagging regulatory framework has left us with many unanswered questions.

Public health officials, nevertheless, were adamant that this new product should be deployed in a one-size-fits-all manner ignoring differential COVID-19 risk profiles across a broad population.

This, in turn, we believe, set the stage for policy overreach resulting in unethical and harmful mandates.

See more here theepochtimes

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