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"Contaminated and Adulterated" Covid-19 Vaccines Should be Pulled from the Market
Dr. Robert Malone, Dr. Ryan Cole, & author Naomi Wolf tell a crowd at the Summit for Truth and Wellness in Rochester, New York, that the shots contain DNA fragments & other hazards known and unknown.
New findings of DNA in 27 vials of Pfizer and Moderna Covid-19 vaccines constitute a legitimate, indeed urgent, reason to pull the mRNA products from the market, experts on Covid vaccine science agreed in public comments at the Summit for Truth & Wellness conference Saturday October 21 in Rochester, N.Y.
The presence of DNA fragments in the mRNA injections raises the unsettling prospect that a foreign genetic material, derived from E. coli, will enter and influence vaccine cells in unpredictable and harmful ways.
While the possible repercussions are unclear, such vaccine “adulteration” is itself an extraordinary breach of the manufacturers’ duty to report all components of vaccines for regulatory review, said members of an expert panel at the conference.
“There are grounds for immediate pulling of the product,” Dr. Robert Malone, a virologist who worked in mRNA vaccination development, told a packed house of about 850 attendees. “Adulteration has always been one of the key parameters that would result in withdrawal of a product from the market.”
The DNA revelations were posted in April on a pre-print server in Canada. On October 19, Health Canada confirmed what five researchers had found in every one of the tested vaccines—the presence of previously undisclosed sequences of DNA.
In an email to Epoch Times, Health Canada, the equivalent agency to the CDC, acknowledged that “the sponsor [Pfizer] did not specifically identify the SV40 sequence" in pre-approval documents. SV40 stands for Simian Virus 40, from which a DNA molecule was derived for use in Pfizer’s manufacturing process.
FDA did not immediately respond to my request for comment. The agency did not directly address the DNA question from journalist Mary Ann DeMasi, after her September 21 interview with Phillip Buckhaults, a cancer genomics professor at the University of South Carolina who independently replicated the findings and testified to the South Carolina legislature on September 13 about potential hazards, raising widespread concern. Instead, the agency assured her, "FDA is confident in the quality, safety, and effectiveness of these vaccines.”
The conference speakers, already universally concerned about deaths, myocarditis, blood clots, fertility issues and other post-vaccine events, detailed their concerns about the findings’ implications.
Dr. Ryan Cole, an Idaho pathologist who early in the rollout spoke out on observed upticks in cancers, was troubled by this injected genetic material. “It can permanently camp out,” he said. “These little circles of DNA can stay within the nucleus. Every time that cell divides…it’s a problem. They’re adulterated. They’re contaminated.”
He said every state’s Attorney General, who bears responsibility for product safety, should be asked why they would allow a vaccine that is contaminated and “has unknown short-, medium- and long-term side effects.”
DNA sequences were found in both Moderna and Pfizer vaccine products in amounts that are of concern, especially for people who receive multiple vaccinations. The Pfizer vaccine raises particular questions, since the SV40 DNA sequence was added belatedly in order to facilitate production of large amounts of DNA that in turn produce the RNA used in the vaccine. It was not disclosed to regulators, speakers said.
Pfizer’s initial vaccine trial, Cole and others said, involved 40,000 people who were given an mRNA vaccine manufactured in the original “process one.” When it proved cumbersome and impractical, the process was revised and the SV40-derived plasmid—a circular DNA molecule—was inserted. With that undisclosed change in the manufacturing process “comes a different risk,” Kevin McKernan, an author of the DNA study and former research manager for MIT’s Human Genome Project, said in a World Council for Health roundtable on October 16.
Warp Speed Failure
Naomi Wolf, co-founder of the Daily Clout, which has analyzed 450,000 pages of court-released Pfizer documents, was harshly critical of the new development, which she said fits a pattern of regulatory failure and unrecognized harms that have characterized the Covid vaccine rollouts.
“This is a bait and switch,” Wolf told the audience, referring to the late-stage manufacturing process change. “We were told process one was going into our bodies, and then they rolled out process two.”
Aided by more than 3,000 volunteer reader-reviewers, the Daily Clout produced 83 reports in 21 months on the Pfizer documents. The effort found many so-called “signals” of harm—including 1223 deaths just in the first three months of Pfizer vaccination campaign.
Most recently, the project obtained heavily redacted high-level government emails indicating that officials were aware of vaccine-associated myocarditis early in 2021. “Instead of coming clean with the American people,” Wolf said, “they doubled down and came up with a strategy to cover it up.”
Referring to the process of assuring the safety and efficacy of such products, Wolf asked, “What happened to pharmacoviligence?”
Amy Kelly, the director of the Pfizer documents analysis, had an answer. Under Operation Warp Speed, FDA took just six weeks to scrutinize the trove of documents that her small army of people have taken months to scour.
“There’s just no way that [a thorough review] actually happened,” Kelly said. “There was not enough time for FDA to look at what was going on. The safety analysis wasn’t there.”
In a telephone interview after the conference, David Wiseman, a vaccine expert and author of the DNA study, told me he agreed the vaccines should be withdrawn based on this new evidence. He also called on commentators to “tone down” their rhetoric surrounding it. “We want to know what damage was done over the last four years,” he said. “Is it a fraud? Adulteration? I have no idea. We need to have the right experiments.”
“Theoretically, everyone agrees that the DNA could be a risk for cancer,” he told me. “The question is does the amount and type of DNA make that concern bigger or smaller.”
Dr. Malone was also cautious. Calling the SV40 sequence fragments “small and residual,” he said the implications of the contaminants, while unknown, might not be as dire as some predict. “This is not full SV40; it’s DNA fragments,” he said, of certain key sequences involved in DNA replication and gene expression. “SV40 is associated with tumors…(but) this isn’t that. In my mind the risk is not acute; I’m not hyper-alarmed about this.”
In an interview after his remarks to the audience, Malone told me, “In my opinion, it is a smoking gun, demonstrating the failure of the FDA to follow its own internal guidance and policies and international norms in regulating vaccines. It is the most egregious example I’ve ever seen. In a normal world, I would expect it [the vaccine] would be pulled.”
The new research, he said, shows “the clear presence of both contaminating DNA fragments at significant levels, and the use of a manufacturing material–this plasmid–that was not disclosed.” That, he said, “is absolutely an example of adulteration and cause for withdrawal from the market.”
Wiseman, who has lengthy experience in medical product development, said there is no exact standard for allowable DNA in vaccines but rather years-old guidance documents that say the products should have no more than 10 nanograms per dose of residual DNA. “We didn’t find that,” he said. However, “people get 5 or 6 or more vaccinations,” he said, adding research is needed on whether the effect is cumulative, similar to repeated exposure to radiation.
The FDA addresses this on its website. “Any official drug which, when tested by compendial methods, fails to conform to compendial standards for quality, strength, or purity, is adulterated unless the differences from such standards are plainly stated on the drug's label.” Only then can regulatory action be taken, the document states. The problem, Wiseman said, is the lack of a “compendial standard” for mRNA vaccines.
Repeal the PREP Act
Driving the failure of vaccine oversight is something called the PREP Act, the conference speakers agreed. Under the Public Readiness and Emergency Preparedness Act, vaccine manufacturers are almost entirely absolved of liability for deaths or injuries from their product. Instead, a government program reviews cases of alleged vaccine harm, rarely awarding compensation.
“What is the deterrent if you are not going to get sued for a shoddy product?” asked Bobbie Anne Cox, an attorney who challenged New York State’s Covid quarantine requirements.
“Doctors also have a shield…There’s no way to be compensated” for injury. “It’s easier to break into Fort Knox.”
Kelly, from the Daily Clout vaccine project, urged attendees to read the act. “You’ll be amazed at how protected everyone is except you,” she said.
Tell representatives,” Wolf said, “get rid of the PREP Act.”
This article is part of a publishing collaboration between RESCUE and Trial Site News. The reporting by Mary Beth Pfeiffer will be simultaneously published in both outlets. Please subscribe to RESCUE and Trial Site News for incisive pandemic reporting.