Researchers confirm DNA contamination in mRNA vaccine vials

The following commentary was written by researchers and scholars with the Canadian Academics for Covid Ethics. Author names and affiliations appear at the bottom of the commentary.

A study led by DNA sequencing lab director Kevin McKernan in Massachusetts raises new and serious safety concerns with the mRNA shots administered worldwide against COVID-19.

The study was published as a preprint six months ago and is still under peer review. However, McKernan shared all the details about his analysis so that other researchers could attempt to replicate his findings independently. And this is happening as we speak, including in the US, Germany, and right here in Canada.

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Photo by Allison Saeng

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So, what do these researchers find in the Pfizer/BioNTech and Moderna COVID-19 vaccine vials?

In addition to the active pharmaceutical ingredient, the (modified) messenger RNA, they also found billions of fragments of DNA that were not known or supposed to be there. Where does this impurity come from? It turns out that both Pfizer’s and Moderna’s large-scale manufacturing processes involve E. coli bacteria fermentation tanks to grow DNA “plasmids,” which later serve as a template to generate the mRNA.

Cleaning up residuals of bacterial host cells is a common and necessary step in the production of microbiological product. Yet, it appears that the world has been offered a contaminated vaccine.

In a new preprint, molecular virologist Dr. David Speicher of Hamilton, Ontario, summarized his testing of 27 vials of monovalent and bivalent COVID-19 mRNA vaccines from 12 different lots by both manufacturers. This Canadian study confirmed the presence of unwanted DNA fragments at levels that far exceed FDA and WHO regulatory guidelines when using one of two available measurement techniques (fluorometry).

The researchers also present an exploratory analysis that suggests a connection between the level of DNA contamination and the rate of serious adverse events among all reported adverse events associated with the corresponding Pfizer lot numbers in the VAERS database.

To make matters worse, in May 2023, Drs. Joshua Guetzkow and Retsef Levi discovered that Pfizer conducted its large Phase 2/3 trial using a “clean” production process that employed the RT-PCR technique to create the DNA templates for mRNA transcription. Yet, the pharma giant switched to the E. coli-based manufacturing process in order to enable mass production of the vaccine.

The published trial protocol specifies that this “Process 2” was to be tested on only 250 participants, while the cleaner “Process 1” vaccine was tested on over 20,000 trial participants. Despite the extremely small number of Process 2 tests, the results appear never to have been submitted to the regulatory agencies. Therefore, the safety and efficacy of the vaccine were established, and authorizations were obtained, for what must be considered a different product than what was later distributed around the globe.

The implications of adverse events from COVID-19 vaccination are many. The lipid nanoparticle envelope around the vaccine ingredients was not only designed to deliver drugs throughout the human body but also facilitate entry into our cells.

Furthermore, oncologist Dr. Phillip Buckhaults, testifying before the South Carolina Senate’s Medical Affairs Committee on 12 September 2023, confirmed McKernan’s earlier findings and argued that the large number of small DNA fragments, which he found in the vaccine vials, increases the likelihood of integration into a cell’s genome with a “reasonable” possibility of causing autoimmune diseases, cardiac arrests, or cancer.

In a social media post, Buckhaults recently emphasized that he views the risks as theoretical and sees “no need to panic about past vaccination.” However, a pertinent fact-check by Agence France Press is unconvincing as the writer does not seem to understand that the DNA contamination is a new discovery, nor do they quantify what they would consider as “lots with unacceptable ingredients” or “significant amounts of genetic material in the shots.”

The fact-checker also focuses on debunking exaggerated online claims rather than the underlying facts and appears stuck in the long-disproven narrative that the injected material stays in the “muscle or skin cells where the vaccine is introduced.”

Amidst the many economic, health, and social damages caused by our response to the COVID-19 pandemic, these new discoveries hit a particularly sour note. How can we trust regulatory agencies like Health Canada if they rubberstamped the approval of a contaminated drug that was switched in at the end of the primary safety and efficacy trial? What does informed consent mean to an injection if the available information refers to a different, purified product? Did the approval and monitoring of the COVID-19 mRNA vaccines comply with current Good Manufacturing Practices (cGMP), a formal system designed to control the quality of food and medicines? Would the impurities in the marketed products be acceptable to Canadians if they were within regulatory thresholds (which is unclear at present), and were these thresholds adapted to the novel mRNA technology?

Sustainable post-pandemic recovery will require honest answers to these and many other pressing questions about our current approach to health and wellbeing.

Claus Rinner, PhD, Professor, Department of Geography and Environmental Studies, Toronto Metropolitan University. Philip Britz-McKibbin, PhD, Professor, Department of Chemistry and Chemical Biology, McMaster University. Steven Pelech, PhD, Professor, Department of Medicine, University of British Columbia. Claudia Chaufan, MD, PhD, Associate Professor, School of Health Policy & Management, York University. Don Welsh, PhD, Professor, Department of Physiology and Pharmacology, Western University.

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