FDA’s Own Study Finds DNA Contamination in Pfizer Vaccines

A peer-reviewed study performed at an FDA laboratory by high school students has confirmed the presence of a high level of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.

by Michael Nevradakis, Ph.D.

A peer-reviewed study performed at a U.S. Food and Drug Administration (FDA) laboratory by high school students has confirmed the presence of a high level of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.

The study, published Dec. 29, 2024, in the Journal of High School Science, was authored by three students at Centreville High School in Clifton, Virginia, and performed under the supervision of FDA scientists.

Maryanne Demasi, Ph.D., an investigative medical reporter, was the first to report on the study.

The research, performed at the FDA’s White Oak Campus in Maryland, found that levels of residual DNA in the Pfizer COVID-19 vaccine were 6 to 470 times higher than regulatory safety limits. The students tested two lots of the vaccine, finding they contained “residual DNA to a level that exceeds 10 ng [nanograms] per dose.”

“The potential health risk posed by residual small DNA fragments is currently unknown,” the study stated. However, the authors also said that DNA contamination may result in insertional mutagenesis — or DNA mutations — that can cause cancer.

Speaking last month on “The Defender In-Depth,” Kevin McKernan, who first identified DNA contamination in the shots in 2023, said DNA in vaccines can pose health risks because the DNA “could integrate into the genome and cause disruption of the genome … or it could disrupt other genes that are related to cancer.”

The FDA did not respond to multiple requests for comment on the study.

COVID vaccines ‘must be immediately recalled’

The new findings challenge “years of dismissals by regulatory authorities, who had previously labelled concerns about excessive DNA contamination as baseless,” Demasi wrote on Substack.

The findings also align with earlier reports from independent laboratories in the U.S., Canada, Australia, Germany and France, she said.

McKernan, founder of Medicinal Genomics, told The Defender that eight studies have found DNA over the limit. “Very few studies are surveying a large number of lots, so each study is additive,” he said.

Epidemiologist Nicolas Hulscher said that in “light of this evidence, the COVID-19 genetic injections must be immediately recalled, to protect the public from further harm.”

Nikolai Petrovsky, Ph.D., director of biotechnology company Vaxine Pty Ltd., told Demasi that the findings are a “smoking gun” and that the new study “clearly shows the FDA was aware of these data.”

Christof Plothe, D.O., a member of the World Council for Health steering committee, agreed. He said:

“So far, the European, Australian, and American health regulatory boards have denied any risks from plasmid DNA contamination in the COVID-19 injections despite nine studies by internationally known research teams.

“All teams concluded that this contamination poses an unacceptable risk to three-quarters of the world’s population. … Three teams so far have demonstrated the integration into human cells. To what extent this is happening to everybody who was injected needs to be investigated.”

McKernan said that the FDA has long ignored evidence of the dangers posed by mRNA COVID-19 vaccines.

“The criteria for pulling these shots was established long before DNA contamination was first discovered,” he said. “I would hope that evidence of highly variable manufacturing would be grounds for immediate class 1 recall from the FDA. They are currently distracted with performing class 1 recalls on non-lethal hairspray.”

A Class 1 recall involves “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

According to Demasi, “The FDA is expected to comment on the findings this week. However, the agency has yet to issue a public alert, recall the affected batches, or explain how vials exceeding safety standards were allowed to reach the market.”

Plothe noted that Demasi presented evidence of DNA contamination to the FDA in September 2024, asking if the agency had launched an investigation or requested further testing of the mRNA vaccines by their manufacturers.

“Nothing resulted from this request,” Plothe said. “As nine studies have proven this severe contamination and repeated requests to health regulatory boards have not led to any consequence, we must ask about the motive.”

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), noted the irony of high school students discovering what the FDA has seemingly missed in the four-plus years since the vaccines’ introduction.

“It is ironic that it takes student researchers at the FDA to do the work of the FDA regulators,” Hooker said. “It is alarming that the public is made aware of this contamination in an obscure journal that features high school science research. One has to ask, ‘Where is the FDA now?’ and ‘Why hasn’t the public been alerted of this?’”

Demasi said that the significance of the new study’s findings is that they came from research performed at an FDA facility.

“Now that DNA contamination of the mRNA vaccines has been verified in the laboratory of an official agency and published in a peer-reviewed journal, it becomes difficult to ignore,” Demasi wrote. “It also places vaccine manufacturers and regulators in a precarious position.”