Plasmid DNA Contamination in COVID-19 Vaccines Is ‘Clear Breach of Informed Consent’ by FDA: Dr. Malone

A health care worker prepares a dose of Pfizer BioNTech COVID-19 vaccine in a file image. Ezra Acayan/Getty Images

Dr. Robert Malone, the inventor of mRNA and DNA vaccines, slammed health regulatory agencies for not informing people about potential plasmid DNA contamination in mRNA COVID-19 vaccines.

An Oct. 19 preprint study found billions of residual DNA fragments in mRNA COVID-19 vaccine vials. While billions of copies of spike, ori, and SV40 enhancer DNA were discovered in the Pfizer vaccine vials, Moderna vials were found to contain copies of ori and spike DNA. The SV40 virus is a DNA virus known to cause cancer in lab animals.

Talking about the study in a Nov. 11 Substack post, Dr. Malone said that plasmid DNA contamination in the vaccines is a “proven fact” that has been “acknowledged by the US FDA, Health Canada, and the European Medicines Agency.”

“In yet another clear breach of informed consent and labeling requirements, this was not previously disclosed to physicians, public health officials, or patients,” he wrote.

For instance, the FDA’s labeling guidelines require that vaccine labels must contain a description of “serious adverse reactions, potential safety hazards, steps that should be taken in the occurrence of a serious adverse reaction and potential safety hazard, and limitations in use imposed by them.”

Pfizer and Moderna COVID-19 mRNA vaccines “are contaminated with plasmid DNA fragments which have not been removed during the current manufacturing processes,” the doctor wrote. A plasmid is a strand of circular DNA that is common to bacteria and specific parasites.

Dr. Malone said that prior FDA guidance on DNA vaccine technology pointed to the presence of “highly active regulatory sequences as being of particular concern due to potential insertional mutagenesis (integration).”

The FDA’s 2009 “Guidance on Prophylactic DNA Vaccines: Analysis and Recommendations” states that concerns about plasmid DNA potentially integrating into the genome of the vaccine recipient and increasing the likelihood of issues like “malignant transformation, genomic instability, or cell growth dysregulation” were raised when DNA vaccines were initially introduced for clinical use.

It stated that a “tiny fraction” of the plasmids are expected to “integrate into the host genome, regardless of the method of delivery.”

Dr. Malone noted that the FDA has issued a “categorical denial of adulteration and risk” of DNA vaccines.

A spokeswoman from the FDA told The Epoch Times that “no safety concerns related to the sequence of, or amount of, residual DNA have been identified” in the COVID-19 shots.

“With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective.”

This denial is contrary to both federal law on adulterated drugs and devices and FDA guidance on adulteration of drugs, Dr. Malone stated.

The U.S. Code on adulterated drugs and devices makes it clear that a drug shall be deemed to be adulterated if its manufacturing, processing, packing, or holding do not meet the requirements of “quality and purity characteristics.”

Meanwhile, the FDA’s law on adulteration of drugs under the Food, Drug, and Cosmetic Act says that a drug would be deemed to be adulterated “if it fails to conform to compendial standards of quality, strength or purity.”

“Compendial standards” refer to the pharmaceutical standards as outlined in the U.S. Pharmacopeia-National Formulary (USP-NF), which is the official quality standards applicable to all drugs sold in the United States.

Regulators, Moderna Admit Risks

As claimed by Dr. Malone, multiple health agencies have admitted to DNA contamination in the mRNA COVID-19 vaccines.In an email to The Epoch Times last month, Health Canada confirmed the presence of the SV40 DNA sequence in the Pfizer vaccine, which the company failed to disclose previously.

In another email to The Epoch Times, the European Medicines Agency also confirmed that the Pfizer vaccine contains the SV40 sequence, which the company’s partner BioNTech did not highlight in its application.

It isn’t clear whether the presence of the SV40 sequence in the plasmid DNA of mRNA vaccines was identified by Pfizer when the company applied for approval from the FDA.

Dr. Malone pointed out that Moderna “clearly acknowledges” the risks of genotoxicity associated with the DNA delivered via its vaccines.

Dr. Robert Malone, author of "Lies My Gov't Told Me", in Washington on Dec. 19, 2022. Jack Wang/The Epoch Times

In an Aug. 8, 2019, patent filed by Moderna regarding RNA vaccines, the company states that the direct injection of naked plasmid DNA into a living host comes with “potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.”

The doctor noted that Moderna considers “even ‘naked’ plasmid DNA” as a potential risk. Naked plasmid DNA does not contain any highly active lipid nanoparticle formulation agents.

Moderna did not disclose in the patent that it has not been able to manufacture such modified mRNA vaccines “without contaminating DNA,” he said.

“In conclusion, it is also clear at this point, unless proven otherwise, that none of these regulatory authorities have obtained data from one or more rigorous, well-controlled studies designed to address the genotoxicity and insertional mutagenesis risks” presented by the mRNA COVID-19 vaccines from Pfizer and Moderna.

Until such data is provided, the FDA’s claim that there are “no safety concerns” related to the residual DNA do not “accurately reflect current knowledge,” Dr. Malone said.

“The only objective conclusion to be made concerning such statements is that they functionally represent propaganda rather than proven scientific and regulatory fact.”

FDA’s ‘Willful Blindness’

In his Substack post, Dr. Malone called the FDA’s assertion of “no safety concerns” about the inclusion of residual DNA in mRNA vaccines “willful blindness.” He then highlighted the risks posed by residual DNA in vaccines.

“The most well-documented risks associated with such potential insertional mutagenesis are cancer (in the case of stem and somatic cells, particularly hematopoietic lineage cells) and birth defects,” he wrote.

“As these highly active modified mRNA (plus DNA fragment) lipid nanoparticles are known to cross the placenta and to localize to ovarian tissue, the potential for birth defects would seem to be of particular regulatory interest and concern.”

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Despite reports of “aggressive cancers” in people who were administered the mRNA vaccines, the FDA remains “willfully ignorant and in denial of these risks.” Moreover, the agency does not define the term “safe” even though it insists that the vaccines are “safe and effective,” Dr. Malone wrote.

He pointed out that FDA and CDC assertions of earlier versions of mRNA COVID-19 vaccines reducing risks of severe disease are now “irrelevant” as these products are not available anymore, and the strains have now become extinct.

“Furthermore, many researchers have demonstrated that, even in those historic cases, after some period of time those so dosed with these products become MORE likely to develop severe disease or death relative to unvaccinated patients (most of whom have acquired natural infection with resulting potent and diversified immunity,” Dr. Malone said.

A September 2022 study found that incidences of COVID-19 infection were “significantly higher in vaccine recipients (6.7 percent) than the previously infected (2.9 percent)” individuals six months after the index date.

For the vaccinated, the index date was defined 30 days after their first COVID-19 shot. For the infected, the index date was taken 30 days after the initial infection.

On the positive side, “all-cause mortality in the vaccinated, however, was 37 percent lower than that of the previously infected. The rates of all-cause ED visits and hospitalizations were 24 percent and 37 percent lower in the vaccinated than in the previously infected.”

Presence of SV40 Sequences

Dr. Malone said that “the presence of highly active promoter/enhancer DNA sequences (and fragments) derived from the SV40 virus, present in the Pfizer/BioNTech product, was not disclosed and discussed with either the public or to the regulatory agencies.”

In order to produce mRNA vaccines, the SV40 enhancer gene from the SV40 virus is used. Using bacteria in the production of genes and proteins for the manufacture of pharmaceuticals is a standard practice.

In the case of the mRNA COVID-19 vaccines, the SV40 enhancer gene and other genetic sequences were introduced in the plasmid DNA. Once the mRNA and DNA are harvested from the bacteria, the DNA is supposed to be removed.

Dr. Malone wrote in his Substack post that “such short DNA fragments are associated with a high risk of integration, otherwise known as insertional mutagenesis, which is a well-characterized form of genotoxicity.” The term genotoxicity refers to the ability of harmful substances to damage the genetic information present in cells.

If these mRNA COVID-18 vaccines were reviewed by the FDA as gene therapy products, they would have required “rigorous genotoxicity studies” before allowed for use among human beings, he said. The same would be true in case the mRNA vaccines were reviewed as “DNA vaccines.”

“But apparently there is something magical about inclusion of modified-mRNA together with DNA fragments in these highly active lipid nanoparticle nucleic acid delivery formulations which leads the FDA to conclude that there is no genotoxicity risk.”