Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
Did Pfizer deliberately deceive regulators about contamination of its COVID-19 vaccine? Yes, according to Kevin McKernan, chief scientific officer and founder of Medicinal Genomics.
Appearing on CHD.TV with Children’s Health Defense (CHD) President Mary Holland and Brian Hooker, Ph.D., CHD’s senior director of science and research, McKernan explained how Pfizer’s COVID-19 vaccine is contaminated with plasmid DNA, which should not be present in an mRNA vaccine.
He said this raises concerns that the plasmid DNA could lead to cancers or autoimmune issues in some vaccine recipients.
McKernan said that annotating Pfizer’s COVID-19 vaccine sequence with a simple online tool — which any trained person can do — reveals the presence of DNA from simian virus 40 (SV40).
But in the data it gave to regulators, Pfizer deleted the annotation of the SV40 DNA and did not disclose its presence. That deletion, McKernan said, shows “intent to deceive.”
This raises serious questions about the vaccine’s safety that must be investigated, McKernan said. It also suggests major problems with the mRNA vaccine regulatory process.
After McKernan’s lab made its findings public, and other researchers confirmed them, Health Canada also confirmed that the Pfizer vaccine contains this DNA. However, the U.S. Food and Drug Administration (FDA) has neither confirmed nor denied the presence of these billions of plasmid DNA fragments in Pfizer’s COVID-19 vaccine.
The FDA told reporter Maryanne Demasi, Ph.D., who questioned the agency on the issue, that it remains “confident in the quality, safety, and effectiveness of these vaccines.”
McKernan and his team stumbled accidentally on what Holland called an “incredibly important finding” when they used the RNA from the Pfizer vaccine — which they assumed was a functional pharmaceutical grade RNA — as a control to test the RNA purification system they were using in other work the lab was conducting.
In the process, they tested vaccines and found that instead of only containing mRNA, the Pfizer vaccines also contained DNA plasmids — small, circular, double-stranded DNA molecules distinct from a cell’s chromosomal DNA.
How did the contaminant DNA get into the vaccines?
McKernan explained that to synthesize the RNA for the vaccines, labs use a process called “in vitro transcription” whereby an RNA-making enzyme called an RNA polymerase uses a DNA template to synthesize RNA molecules.
“It’s like the ink for your Xerox machine,” McKernan said.
But the DNA first has to be amplified. For the clinical trials, Pfizer amplified the DNA using PCR (polymerase chain reaction), a method it called “Process 1.” McKernan said this process is ideal because it amplifies the DNA a millionfold. As a result, “There’s no residual background. You get a really clean piece of DNA that you can make your RNA from.”
But to scale up the process to mass produce vaccines for the public, McKernan said, Pfizer did a “bait-and-switch,” producing the vaccines using “Process 2.”
Process 2 includes “changes to the DNA template used to transcribe the RNA and the purification phase, as well as the manufacturing process of the lipid nanoparticles,” Josh Gueztkow and Retsef Levin wrote in a letter, published in the BMJ, which raised concerns with the process.
For Process 2, rather than amplifying DNA with PCR to make the template, vaccine makers amplified the DNA by plugging it into a bacterial plasmid vector, which uses E. coli for rapid amplification, but runs the risk of introducing sequences not present in the initial DNA, McKernan said.
This creates a practically infinite supply of DNA much more cheaply and easily than using PCR, he added.
But this DNA template comes with additional risk because the DNA of the plasmid used to create the template has to be removed from the vaccine before it can be injected into people.
He said it is clear the vaccine makers tried to get rid of that DNA by “chewing it up with an enzyme” called deoxyribonuclease, or DNase, which breaks down DNA, but they failed to eliminate it completely.
Why didn’t the DNA-destroying enzymes eliminate the DNA?
McKernan told Holland and Hooker the DNase failed to fully eliminate the contaminant DNA fragments from the vaccines delivered to the market because of the modifications they made to the RNA in order to make the mRNA vaccines function, and because of “blind spots” in how they measured the amount of residual DNA.
To make the mRNA vaccines work the way they wanted to, the vaccine designers had to make the RNA slightly more durable than usual, he said.
DNA, he said, is like a hard drive — it’s a long-lived form of information storage. RNA is temporary — like the task manager of the programs that are opening and closing on the hard drive.
Those programs and the RNA itself, get turned on and off. For RNA, an enzyme called RNase functions as an on/off switch.
The makers of the mRNA vaccines added a nucleotide, N1-Methylpseudouridine, that stopped the RNA from turning off right away so it would remain present to ensure the spike protein was produced “long enough to matter,” McKernan said.
That made the RNA “extraordinarily sticky,” so when the RNA polymerase copies the RNA off of the DNA template, it accidentally makes some RNA-DNA hybrids, a triple helix.
In that context, the DNase enzyme that was supposed to get rid of the template DNA can’t function properly.
McKernan said it was likely that the vaccine developers didn’t anticipate that would happen and they would therefore need to develop different enzymes.
“I think with the Warp Speed program, they didn’t really have time to investigate this,” he said.
The second reason the DNA is still there, he said, is because of the tools Pfizer used to measure the DNA and the RNA. Pfizer could measure them both with a single tool, called fluorometry, which can identify very tiny pieces of DNA and RNA.
But, he said, instead Pfizer is using fluorometry only for the RNA, which will give the vaccine developers inflated numbers, and the vaccine maker is using a different tool, called qPCR for the DNA, which can’t identify such small pieces of DNA and so will produce deflated numbers.
“They are playing some games” with these measuring tools, McKernan said, because regulators will want them to have high RNA numbers and low DNA numbers — and by measuring RNA and DNA with different tools, that’s exactly what they get.
That, he said, suggests “intent to deceive.”
What’s in the DNA and why should we be concerned?
Hooker asked McKernan to explain what “is hiding” in this remnant DNA and why people should be concerned.
McKernan said “hiding” was an apt term, because Pfizer gave the whole sequence to the regulators, but only annotated certain parts of it, which allowed it to hide some of the contents.
He said anyone can plug the sequence into a standard annotation software tool like SnapGene, and it automatically annotates the entire sequence — and he wrote a Substack post showing people how to do this.
He also showed Holland and Hooker a side-by-side comparison of the software’s annotation and Pfizer’s annotation, and he showed them where a key annotation was missing in Pfizer’s regulatory submission.
McKernan said that annotation marked the location of the fragments of SV40 virus— which Pfizer used as the necessary promoter and enhancer to drive gene transcription during the vaccine manufacturing process.
Someone had to delete those annotations before giving them to the regulators, he said.
SV40 is controversial because it was an artifact of the live polio vaccine and some experts say it is a cancer risk due to potential integration with the human genome.
To really understand the possible risks, McKernan said, more data have to be collected.
“We have a lot of reasons to believe this is a bad idea. They don’t need this DNA in there. They didn’t tell the regulators about it.”
He added:
“So all of that is a train wreck. If you’re putting in 200 billion of these molecules per shot and you’re doing them five times a year … I don’t know how many times people are taking them, but if you think of your schedule, you should be past your fifth by now. So there’s a cumulative dosing problem here. There’s a high number of these fragments in there.”
Even though the amount of DNA overall may be small, McKernan said, it has been fragmented into tiny pieces that make it “like a buckshot,” meaning it scatters like a shotgun bullet, hitting a broad area, which makes them “much more potent as integration tools because you have more active ends of DNA.”
Concerns beyond SV40: gene therapy and ‘open reading frames’
The U.S. regulatory structure is completely outdated, McKernan said. The current regulations allow for fairly high quantities of DNA because they are based on the idea that the DNA takes the form of a dead virus.
But mRNA vaccines are bringing these DNA sequences into the body in lipid nanoparticles that target the cell nucleus.
Hooker said, “We were told this [mRNA] would not target the nucleus. Is the nuclear targeting sequence the SV40 enhancer?”
McKernan said it is. In fact, he said, SV40 has been successfully researched as a gene therapy tool.
“There’s just no debate anymore. The plasmids that are in there are gene therapy tools, and they’re injected into billions of people,” he said.
Holland asked, “So not only was there no informed consent for anybody, and this was Emergency Use Authorization, so, by law, they weren’t able to give truly informed consent, but it looks like this was a gene therapy, and people were not told that this was a gene therapy. Is that right?”
“That’s right,” McKernan responded.
Holland asked McKernan whether, now that Health Canada acknowledged the presence of SV40, he thought all governments should take the vaccine off the market until this issue is investigated.
“I would think so,” McKernan said. “If they don’t do this, what are they there for?”
McKernan said he also identified other concerns in Pfizer’s mRNA vaccine sequence.
For example, he showed Holland and Hooker that the sequence contains an Open Reading Frame — a DNA sequence with no “stop codon” or stop signal — that is 1,252 amino acids long on the reverse strand of the spike protein in the Pfizer sequence.
Despite extensive research, he said, he can’t identify what it is. “I don’t know what this does, but I know that this is an artifact of their codon optimization that should not be there and is a massive risk and they should get rid of it.”
Hooker asked what the implications of that might be. McKernan said it was unknown, but regulators should never have let it through because it is “risk with no gain and it’s unnecessary.”
Watch here:
