News/Commentary

Florida Surgeon General calls for halt to COVID vax, FDA claims cited concerns are ‘implausible’

January 4, 2024 | | Print Article

Florida State Surgeon General Dr. Joseph Ladapo called on healthcare providers to hit the brakes on the COVID-19 mRNA vaccines, citing concerns that doses of the Pfizer and Moderna jabs are contaminated with “billions of DNA fragments.”

“The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have always played it fast and loose with COVID-19 vaccine safety, but their failure to test for DNA integration with the human genome — as their own guidelines dictate — when the vaccines are known to be contaminated with foreign DNA is intolerable,” Ladapo said in a statement.

“I am calling for a halt to the use of mRNA COVID-19 vaccines,” the doctor declared on X.

In a December 6, 2023, letter to “the United States Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf and Center for Disease Control and Prevention (CDC) Director Dr. Mandy Cohen,” Lapado questioned “the safety assessments and the discovery of billions of DNA fragments per dose of the Pfizer and Moderna COVID-19 mRNA vaccines,” according to a press release from his office.

“The Surgeon General outlined concerns regarding nucleic acid contaminants in the approved Pfizer and Moderna COVID-19 mRNA vaccines, particularly in the presence of lipid nanoparticle complexes, and Simian Virus 40 (SV40) promoter/enhancer DNA,” the release explains. “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. The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk of DNA integration into human cells.”

Lapado noted in the release the FDA’s own 2007 guidelines pertaining to “regulatory limits for DNA vaccines” which warned that “DNA integration could theoretically impact a human’s oncogenes – the genes which can transform a healthy cell into a cancerous cell.”

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“DNA integration may result in chromosomal instability,” the FDA said at the time, according to Lapado. “The Guidance for Industry discusses biodistribution of DNA vaccines and how such integration 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.”

A top FDA official, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, dismissed Lapado’s concerns as “misinformation and disinformation.”

Marks wrote in a Dec. 14 letter that “it is ‘implausible’ that residual small DNA fragments could find their way into the nucleus of human cells and then alter DNA to cause cancer,” according to Fox News Digital.

“We would like to make clear that based on a thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines,” Marks stated in the letter. “Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”

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The biggest challenge facing regulators, he continued, “is the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake.”

Lapado argued that the FDA failed to address his questions.

“The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed. Instead, they pointed to genotoxicity studies – which are inadequate assessments for DNA integration risk,” the surgeon general said in a statement. “In addition, they obfuscated the difference between the SV40 promoter/enhancer and SV40 proteins, two elements that are distinct.”

“DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients,” he explained. “If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings.”

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“Providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines and treatment,” Lapado said. “It is my hope that, in regard to COVID-19, the FDA will one day seriously consider its regulatory responsibility to protect human health, including the integrity of the human genome.”

Melissa Fine
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