FDA Responds to Reports of DNA Contamination in COVID Vaccines
FDA Responds to Reports of DNA Contamination in COVID Vaccines

By Jack Phillips

The U.S. Food and Drug Administration (FDA) responded to concerns about there are billions of plasmid DNA fragments in Pfizer’s COVID-19 vaccine—as a university researcher recently testified in front of a South Carolina Senate hearing.

“The mRNA COVID-19 vaccines authorized or approved for use in the United States are not defined as a gene therapy,” the FDA told Maryanne Demasi, a former Australia Broadcasting Corporation journalist who now operates a Substack page. She noted that the FDA spokesperson didn’t answer specific questions about the DNA fragments.

Continuing, the spokesperson said that the “FDA is confident in the quality, safety, and effectiveness of these vaccines” and added that the “agency’s benefit-risk assessment and ongoing safety surveillance demonstrates that the benefits of their use outweigh their risks.”

The agency was responding to Demasi’s interview with Dr. Phillip Buckhaults, a cancer genomics expert and a professor at the University of South Carolina, who said that “there is DNA contaminating the vaccine, but I was also able to put a stop to some of the rumors on social media about the SV40 virus being in the vaccine and that it’s going to give everybody cancer because that’s not true.” He’s referring to allegations that a virus that can infect both monkeys and humans—that sometimes causes tumors—was giving people cancer after vaccinations.

“There’s just a piece of SV40 promoter in the vaccine,” he added in the article. “And that’s what people were seizing on, people were saying there’s a monkey virus, we’re all going to turn into monkeys or get cancers next week or something,” the professor added, referring to the earlier claims on social media it being the cause of cancers. ” And, and I did my due diligence to tamp down that kind of fear—which was my original purpose.”

Regarding the DNA fragments found in the Pfizer vaccine, the size of the tiny particles is what matters, Dr. Buckhaults said.

“The FDA says 10 nanograms. Now 10 nanograms could be from one molecule that’s absurdly ginormous. Or it could be a whole bunch of little bitty molecules. And the hazard for genome modification is not a function of the mass,” he continued. “It’s a function of how many independent molecules you’ve got. So, it’s actually way worse, having a whole bunch of these little pieces in terms of a risk of some insertional mutagenesis happening. That’s way worse than even having one big piece leftover. Right?”

However, he opined that there likely isn’t “anything nefarious” at play and instead, “kind of accidentally administratively dumb.”

What may have happened, according to the researcher, is that Pfizer, federal officials, and others “were scared to death” about COVID-19 in 2020 when the vaccines were being worked on and that mistakes were made.

“It’s easy to sit back here now, in the safe comfort that the fear has passed and now, we’re all sitting in our offices, and nobody’s scared about the world coming to an end, and then throw rocks at what was done three years ago  …  think that’s really unfair. I really think that mostly people were working in good faith to try to put fire out,” Dr. Buckhaults argued.

The Epoch Times has contacted the FDA and Pfizer for comment on Friday.

Dr. Buckhaults had made reference to research done by microbiologist Kevin McKernan, a researcher who worked on MIT’s Human Genome Project who said he found that the amount of DNA in vaccines could be 18 to 70 times higher than the limits required by a top health agency.

Earlier this year, Dr. McKernan published a paper finding that the quantities of DNA contamination in the vaccines exceeded the European Medicines Agency’s 330 ng/mg of DNA to RNA requirement by between 18 and 70 times. It’s also higher than the FDA’s 0 ng/dose requirements, and it had a reading of 12 ng/dose.

At the time, he warned that the DNA plasmids could infiltrate the human genome, contradicting public statements made by the FDA and other regulators that COVID-19 vaccines do not alter human DNA.

A health worker uses a needle and a vial of Pfizer-BioNTech COVID-19 vaccine to prepare a dose at a vaccination health centre in a file photo. (Justin Tallis/AFP via Getty Images)

Over the summer, Dr. Buckhaults posted some of his findings on X, formerly Twitter, that there were as many as 2.5 billion molecules of plasmid and about 100-200 billion pieces of plasmid DNA that his sequencing identified in a Pfizer dose of 300 microliters. According to a previous Epoch Times report, this equates to some 20 ng per dose or about double the limit set by the FDA and other health bodies.

“There are pieces of plasmid DNA in the vaccine. No one knows if this DNA does anything clinically significant, but it is prudent to check vaccinated people for any evidence of genome modification,” Dr. Buckhaults told The Epoch Times several weeks ago. “If found, it could motivate changing the regulatory guidelines by lowering the limits for allowable DNA in a lipid-nanoparticle based vaccine.”

Like the FDA’s response this week, Health Canada—a Canadian health agency—didn’t express any concern about his findings.

“Health Canada was aware of the presence of residual plasmid DNA as a process-related impurity during review and prior to the authorization of the mRNA COVID-19 vaccines,” the agency told The Epoch Times several weeks ago.

What Happens to Vaccinated People?

In the interview with Ms. Demasi, Dr. Buckhaults elaborated on the potential risks that Pfizer-vaccinated individuals face. More research is needed, he suggested.

“People will disagree on the magnitude of the risk. We do not yet know if it means anything or not. There’s a chance that this DNA does nothing,” he explained.

But he cautioned that “there is a reasonable chance that if you inject pieces of DNA that are wrapped up in this transfection particle—the lipid nanoparticles—there is a reasonable chance that some of this is going to get into cells, and then integrate into the genome of cells. I think we should check and find out.”

Two things that could occur, Dr. Buckhaults added, is the “small possibility of cancers in people in the next five years down the road, or the possibility of autoimmunity from the production of these peptides,” referring to an autoimmune response such as myocarditis.

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