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Florida Surgeon General Joseph Ladapo, M.D., Ph.D., today called for a “halt in the use of COVID-19 mRNA vaccines” over safety concerns that the mRNA technology is delivering DNA contaminants into people’s cells.
In a statement released today by the Florida Department of Health, Ladapo said the U.S. Food and Drug Administration (FDA) failed to adequately respond to questions he raised about the issue in a letter sent last month to the FDA and the Centers for Disease Control and Prevention (CDC).
Ladapo asked the agencies to address the recent discovery of host cell DNA fragments in the Pfizer and Moderna mRNA vaccines. Scientists studying the vaccines found bacterial DNA left over from the microscopic plasmids used for multiplying DNA in the mRNA vaccine manufacturing process.
One of the gene therapy tools discovered in COVID-19 vaccines is SV40, which is known to be cancer-promoting.
Ladapo’s letter said the presence of these fragments was particularly concerning given that the mRNA shots use lipid nanoparticles, which he said are “an efficient vehicle for delivery of 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 asked the agencies to explain whether the risks of contaminant DNA being integrated into human cells had been assessed, per the agencies’ own guidelines, especially given the new risk factors introduced by the use of lipid nanoparticles.
In the FDA’s response, Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research at the FDA, reiterated that the agency is “confident in the quality, safety, and effectiveness of the COVID-19 vaccines.”
Marks also said that “on first principle, it is quite ‘implausible’ that residual small DNA fragments” could “find their way into the nucleus,” of cells and be incorporated into chromosomal DNA. He added that the FDA’s pharmacovigilance data on hundreds of millions of individuals “indicate no evidence indicative of genotoxicity.”
The real challenge facing the FDA, Marks said, is “the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake.”
Ladapo said the response did not sufficiently address his concerns.
“The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed,” Ladapo said. “Instead, they pointed to genotoxicity studies — which are inadequate assessments for DNA integration risk.”
In his statement, Ladapo reiterated that “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.”
“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,” Ladapo said.
An outspoken critic of COVID policies
Ladapo, a distinguished graduate of Harvard Medical School and well-published medical researcher, gained prominence early in the pandemic for arguing that fear — not sound public health science — was driving public messaging around COVID-19.
He published a series of articles in USA Today and The Wall Street Journal criticizing lockdown measures and arguing the health system “would be less burdened if more patients were treated before they require hospitalization, and there are promising therapeutic options that patients can administer themselves at home.”
Ladapo’s outspokenness and his approach to handling the pandemic caught the eye of Florida Gov. Ron DeSantis, who appointed him as the state’s surgeon general in September 2021.
Since then, he has been vocal in challenging federal policies and recommendations related to the COVID-19 mRNA vaccines and calling for agency accountability.
He issued an alert in Feb. 2022 to the Florida healthcare sector and the public warning that COVID-19 mRNA vaccines caused a “substantial increase” in reports of adverse events in Florida.
In March 2022, Ladapo recommended against COVID-19 vaccines for healthy children, making Florida the first state to break with official guidance from the CDC.
Last year he recommended against anyone under the age of 65 getting new COVID-19 vaccine boosters.
Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master's from the University of Texas at Austin.
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