The Food and Drug Administration is launching an investigation into the DNA contamination plaguing COVID-19 shots.
I’ll say that that is something that’s being discussed,” Dr. Tracy Hoeg, a senior adviser to the FDA’s commissioner, told members of the Centers for Disease Control and Prevention’s vaccine advisory panel on Sept. 19.
Theepochtimes.com reports: Before the panel’s members unanimously recommended during the meeting that the CDC roll back COVID-19 vaccine recommendations, a number expressed concerns about growing evidence of higher-than-allowed levels of DNA in the vaccines, the spreadofthevaccinebeyond the injection site, and the long-term persistence of messenger ribonucleic acid (mRNA)—a key part of the Pfizer-BioNTech and Moderna shots.
The CDC has described mRNA as the entity teaching cells how to make copies of the spike protein to enable protection when the real virus, with its own spike protein, attacks the body. “After the mRNA delivers the instructions, your cells break it down and get rid of it,” a CDC graphic states.
Retsef Levi, chair of the advisory panel’s COVID-19 immunization workgroup, showed the graphic during the meeting.
“We have a range of things on the mRNA platforms that really suggests that it doesn’t work as intended,” Levi said, citing issues such as the spread of spike protein and mRNA into various parts of the body and “DNA contamination.”
Sequence Not Highlighted, Residual DNA Found
Canadian officials in 2023 confirmed to The Epoch Times that Pfizer’s vaccine contained a DNA sequence that the manufacturer had not highlighted. Some scientists, including former Johnson & Johnson scientist David Wiseman, said they were concerned about the impact of residual DNA left behind by the sequence, which had been used in the past for manufacturing other drugs.
That DNA could integrate into the human genome and create autoimmunity problems, Kevin McKernan, who has confirmed the presence of residual DNA in COVID-19 vaccine vials, told The Epoch Times.
The FDA, in a brief statement in 2023, did not say whether it was aware of the sequence.
“With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified,” a spokesperson said at the time. “With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective.”
While the sequence has not been detected in Moderna’s vaccine, other testing has found DNA in both the Pfizer and Moderna shots. McKernan and other researchers in a paper published on Sept. 6 said they found levels of residual DNA in vaccines from the companies that were higher than the regulatory limit set by the FDA.
Why Not Withdrawn?
Dr. Kirk Milhoan, another member of the CDC vaccine advisory panel, said during the meeting that he was “shocked at the lack of pharmacological rigor in dosing,” including dose accumulation, as well as the evidence that the vaccines were contaminated.
“Why is this not pulled off [the market] like any other biologic or medicine that is found to have contamination?” he stated.
Hoeg, the FDA official, told him that some of the relevant information is proprietary.
“I will say the information that we have been provided by Pfizer and Moderna, and what was shared with me, is what they provided to the FDA; it was within the regulatory limits,” she said.
“I will also acknowledge that this is something we take very seriously, and I want to sincerely thank the independent researchers, many of whom I know, who have brought this issue to the public’s attention.
“And at the FDA, we take the public’s safety and the safety of these products incredibly seriously. And I just want to give you all that message that this is not something that is being ignored.”
That’s when Milhoan asked whether the FDA planned an independent evaluation of the products.
“I’ll say that that is something that’s being discussed,” Hoeg said. “Again, we want to communicate that we take this issue very seriously and thank everyone who has brought this to our attention.”
Member Comments on Developments
The new FDA leadership withdrew the emergency authorization for the COVID-19 vaccines but approved them for limited groups, citing a need for the companies to run trials proving effectiveness in younger, healthier populations. The FDA’s commissioner also announced recently that the agency is investigating reported child deaths following COVID-19 vaccination.
“The shift in focus and openness to investigation of these issues is new,” Dr. Robert Malone, another CDC adviser, told The Epoch Times.
“Previously, the FDA was unwilling to look at issues such as lot consistency and adulteration in these products, and that’s just not consistent with established regulatory norms,” he added later.
The FDA did not respond to a request for comment by the time of publication.
Levi wrote on X that the discussions during the meeting were the first time the advisory panel went over “critical risks and uncertainties like immune response to repeated boosting, biodistribution, pharmacokinetics, and potential impurities.”
Levi and Milhoan, before they were appointed to the panel, called for the Pfizer and Moderna vaccines to be withdrawn. Malone in 2023 said that regulators should withdraw the Pfizer vaccine due to the presence of the DNA sequence, which he said made the product adulterated.
What the Companies Said
Darin Edwards, a Moderna executive, told advisers during the meeting that outside testing of the vaccines has been flawed.
“Part of our release testing is [the] detection of DNA in each lot,” he said. “We use industry-standard methods to perform these assessments. That is specific to DNA and does not detect RNA, which is a flaw and a problem with some of the other methods cited.”
A Pfizer official added: “We did measure residual DNA within our product, and our assay was validated to be specific for residual DNA and not RNA within the product.”
Dr. Wafik El-Deiry, director of the Legorreta Cancer Center at Brown University, said in a presentation to the panel that the FDA limits for DNA were for “naked DNA,” or unencapsulated DNA. The COVID-19 vaccines are encapsulated by lipid nanoparticles to help prolong the mRNA so it can teach the body.
Malone asked the companies during the meeting: “The thresholds that were used to establish that you were within allowed parameters, are those that the FDA determined as acceptable for naked DNA?”
“The thresholds were developed for our product,” a Pfizer representative said.
“The product thresholds are for our specific product,” Edwards said.
Dr. El-Deiry’s Response
El-Deiry told The Epoch Times in an email that he interpreted the comments as the companies using certain quality control assays that suggested to them that the DNA impurities were within FDA limits.
“The sensitivity of their assays has been questioned and clearly multiple others have identified DNA impurities that exceed the 10 ng FDA limit, and such DNA was present after they eliminated RNA by using powerful ribonucleases,” or enzymes, El-Deiry said.
While the exact impact of the impurities remains unclear, a number of case reports and case series have described cancer developing in vaccinated individuals shortly after vaccination, El-Deiry told the panel.
A Moderna representative told the committee: “We note that one of today’s presentations includes assertions not aligned with the broader scientific evidence. Some conclusions extend beyond what referenced studies support or are contradicted by careful reading.
“Others appear based on isolated case reports that are presented without relevant clinical context, or omit a larger body of evidence to the contrary.”
The panel later voted to recommend that people should only receive COVID-19 vaccines after consulting with health care providers and considering individual factors, such as whether they have an underlying condition, such as obesity.
Members also said the CDC should add more information about the vaccines to information statements, including that “prolonged and persistent exposure to spike, mRNA and nano-lipids particles is associated with post-vaccine syndrome (PVS) injuries as well as potentially other side effects that are currently only partially understood,” and that doctors should discuss such risks, as well as benefits, before proceeding with vaccination.