Florida Surgeon General Demands Answers After ‘DNA Fragments’ Found in COVID Shots

Florida Surgeon Gen. Dr. Joseph Ladapo speaks during an event in a file photograph. Chris O'Meara/AP Photo

Florida Surgeon General Dr. Joseph Ladapo on Wednesday demanded federal health officials shed light on the discovery of DNA fragments in the Pfizer and Moderna COVID-19 mRNA vaccines “hitchhiking into human cells.”

In a letter, Dr. Ladapo asked Dr. Robert M. Califf, commissioner of the U.S. Food and Drug Administration (FDA), to address the findings by researchers. Dr. Mandy Cohen, director of the Centers for Disease Control and Prevention (CDC), was also included in the letter.

“I am writing to you to address the recent discovery of host cell DNA fragments within the Pfizer and Moderna COVID-19 mRNA vaccines,” Dr. Ladapo wrote in his letter.

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Of particular concern, he noted, was the “presence of nucleic acid contaminants” in the approved monovalent and bivalent mRNA jabs, which were detected “in the presence of lipid nanoparticle complexes, and Simian Virus 40 (SV40) promoter/enhancer DNA.”

“Lipid nanoparticles are an efficient vehicle for delivery of the mRNA in the COVID-19 vaccines into human cells, and may therefore be an equally efficient vehicle for delivering contaminant DNA into human cells,” he noted. “The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk of DNA integration into host cells.”

Major Risks

Dr. Ladapo has raised several concerns with the FDA, the federal agency responsible for approving the shots, and the CDC over COVID-19 vaccines and criticized the rollout of shots in September, saying there weren’t sufficient clinical trials. Earlier this year, he raised the alarm with the FDA about Florida observing a 4,400 percent increase in reports of life-threatening conditions since the rollout of the mRNA COVID-19 vaccines.

Citing FDA guidance from 2007, Dr. Ladapo noted in his Dec. 6 letter the potential risks associated with DNA integration. He emphasized the need for a comprehensive assessment of the risks of contaminant DNA integration into human DNA, particularly given the wide biodistribution of mRNA COVID-19 vaccines.

Per FDA guidance, there are three significant potential risks associated with DNA integration, including impacts on human oncogenes, chromosomal instability, and certain body parts.

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“DNA integration could theoretically impact a human’s oncogenes—the genes which can transform a healthy cell into a cancerous cell,” Dr. Ladapo noted.

“DNA integration may result in chromosomal instability,” his second point noted. Furthermore, the FDA’s guidance discusses the integration of the biodistribution of DNA vaccines, which “could affect unintended parts of the body, including blood, heart, brain, liver, kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, the site of administration, and subcutis at injection site.”

Demanding Answers

Citing the recent detection of DNA fragments in the vaccines, the FDA’s 2007 guidance, and the efficacy of the COVID-19 mRNA vaccine’s lipid nanoparticle delivery system, the Florida surgeon general posed three crucial questions to the FDA commissioner:

1. Have drug manufacturers evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from the mRNA COVID-19 vaccines alongside the additional risk of DNA integration from the lipid nanoparticle delivery system and SV40 promoter/enhancer? Has FDA inquired any information from the drug manufacturers to investigate such risk?
2. Do current FDA standards for acceptable and safe quantity of residual DNA (present as known contaminants in biological therapies) consider the lipid nanoparticle delivery system for the mRNA COVID-19 vaccines?
3. Considering the potentially wide biodistribution of mRNA COVID-19 vaccines and DNA contaminants beyond the local injection site, have you evaluated the risk of DNA integration in reproductive cells with respect to the lipid nanoparticle delivery system?

Dr. Ladapo noted that Dr. Califf and then-CDC Director Dr. Rochelle Walensky had not responded to a previous letter dated Nov. 19, in which he accused the health officials of ignoring several risks surrounding the mRNA COVID-19 vaccines.

“The American people and the scientific community have a right to have all relevant information pertaining to the COVID-19 vaccines to properly inform individual decision-making,” Dr. Ladapo wrote.

Noting the “urgency of these questions due to the mass administration” of COVID-19 mRNA shots, he demanded a written response by Dec. 13, addressing the concerns he raised in both his Dec. 6 and Nov. 19 letters.

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“If he doesn’t have answers, who gave him the right to treat human beings as guinea pigs?” the Florida surgeon general said in a post on X, referring to Dr. Califf.

A spokesperson from the FDA said the agency “has received the letter and will respond directly to the Florida Surgeon General.”

This report was updated with the FDA’s comment.