Following testimony from a university researcher, who testified in front of a South Carolina state hearing, the U.S. Food and Drug Administration has responded to concerns about billions of plasmid DNA fragments in Pfizer’s COVID-19 vaccine.
“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 is now independent and writes through Substack, who noted that the FDA spokesperson didn’t answer specific questions about the DNA fragments.
The spokesperson continued, saying that the “FDA is confident in the quality, safety, and effectiveness of these vaccines” and adding that the “agency’s benefit-risk assessment and ongoing safety surveillance demonstrates that the benefits of their use outweigh their risks.”
This came in response to Demasi’s interview with Dr. Phillip Buckhaults, a cancer genomics expert and professor at the University of South Carolina, who told her 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.”
Buckhaults spoke in reference to allegations that SV40, a virus that can infect both humans and various forms of primates and can sometimes cause 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.”
Turning back to the DNA fragments found in the Pfizer vaccine, Buckhaults said that the size of the fragments is what matters most.
“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 believes that there isn’t “anything nefarious” at play, but that the move was “kind of accidentally administratively dumb.” He believes that Pfizer, federal officials and others were “scared to death” about COVID-19 in 2020 while the vaccines were being worked on and that mistakes were made in their production.
“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,” Buckhaults argued.
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