DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada
Investigation into 8 Pfizer and 19 Moderna modified RNA COVID-19 vaccines from 12 unique lots, including the newly released Moderna Spikevax monovalent XBB.1.5 booster
For if you remain silent at this time, relief and deliverance for the Jews will arise from another place, but you and your father’s family will perish. And who knows but that you have come to your royal position for such a time as this? - Esther 4:14
We all have struggles. Those who know me well know that I have had a severe stutter since I was a child and that I have often been teased and discriminated against for my stutter and faith, but I have never been one to back down from disseminating the truth. In Grade 12, I had a high school guidance counselor tell me to never attempt university because I would never make it in life. Sure, it hurt to hear those words, but it did not deter me. I was inspired and completed an MSc (Hons) in Clinical Microbiology and a PhD in Virology from Griffith University (Queensland Australia) and have been an integral part of cutting-edge research in Australia, Kenya, India, and Canada.
Many of us have heard of the problems with the COVID vaccines including the biodistribution issues and increased rates of myocarditis. As a virologist and colleague of many of the heroes, like Drs. Byram Bridle and Pierre Kory, I have often thought about my role in the pandemic. Over the past several months I have collaborated with Kevin McKernan, Dr. Jessica Rose, Dr. Maria Gutschi, and Dr. David Wiseman to investigate the levels of residual DNA in 8 Pfizer and 19 Moderna modified RNA COVID-19 vaccines from 12 unique lots, including the newly released Moderna Spikevax monovalent XBB.1.5 booster. Using VAERS data we were able to perform some exploratory analysis comparing residual DNA loads to adverse events and serious adverse events.
Our key findings are as follows:
1. Residual plasmid DNA from Process 2 manufacturing is found in all Pfizer and Moderna COVID-19 vaccines as high as 4.27 ng/dose.
2. Using Qubit fluorometry the residual plasmid DNA is as high as 5,100 ng/dose equating to 188 – 509-fold excess of the FDA and WHO 10 ng/dose guidelines.
3. Pfizer contained more amplifiable DNA than Moderna and all Pfizer contain the SV40 promoter-enhancer-ori.
4. A positive dose-response relationship was observed for the Pfizer lots based on qPCR estimation of residual DNA.
5. The most recent Moderna XBB.1.5 vaccine contained similar levels as other Moderna lots suggesting that DNA residues have not been reduced and remains an issue.
This work highlights the need for regulators and industry to adhere to the precautionary principle, to provide sufficient and transparent evidence that products are safe and effective, and to disclose the details of their composition and method of manufacture.
The full preprint manuscript can be read here.