by Brenda Baletti, Ph.D., Childrens Health Defense:
In a statement released today, Florida Surgeon General Joseph Ladapo, M.D., Ph.D., said the U.S. Food and Drug Administration failed to adequately respond to questions he raised in a letter last month about mRNA technology delivering DNA contaminants into people’s cells.
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.
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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.
I am calling for a halt to the use of mRNA COVID-19 vaccines. pic.twitter.com/olg8VTh6gB
— Joseph A. Ladapo, MD, PhD (@FLSurgeonGen) January 3, 2024
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