On Wednesday, Florida Surgeon General Joseph A. Ladapo called for a complete halt in the use of COVID-19 mRNA “vaccines” due to DNA contaminants in the products that can affect unintended parts of the body and lead to “turbo cancers” among recipients.
Without a proper assessment of the risks of DNA integration, “these vaccines are not appropriate for use in human beings,” the surgeon general said in a press release.
Dr. Ladapo’s move comes after he sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf and Center for Disease Control and Prevention (CDC) Director Dr. Mandy Cohen last month demanding answers to his questions regarding the discovery of billions of DNA fragments per dose of the Pfizer and Moderna COVID-19 mRNA injections.
Ladapo, a Harvard-trained MD and PhD, was not satisfied with the FDA’s response.
In his December 6 letter, the Surgeon General had outlined his “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.”
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.
In his letter, Ladapo also noted that “DNA integration may result in chromosomal instability” and “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.”
He pointed out that the integration of DNA fragments into human cells can lead to oncogenesis, the process through which healthy cells become transformed into cancer cells, a risk, he noted, the FDA had previously acknowledged.
In 2007, the FDA published a guidance on the regulatory limits for DNA vaccines in a Guidance for Industry: “Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (Guidance for Industry).”
Ladapo said that in the Guidance for Industry, the FDA outlined “important considerations for vaccines that use novel methods of delivery regarding DNA integration.” Those considerations included:
DNA integration could theoretically impact a human’s oncogenes – the genes which can transform a healthy cell into a cancerous cell.
DNA integration may result in chromosomal instability.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.
In the FDA’s December 14 written response, Dr. Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research at the FDA, said that the agency is “confident in the quality, safety, and effectiveness of the COVID-19 vaccines.”
Marks insisted 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.”
He added that the real challenge facing the FDA is “the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake.”
According to the surgeon general, Marks “provided no evidence that DNA integration assessments have been conducted to address risks” in the FDA’s response.
“Based on the FDA’s recognition of unique risks posed by DNA integration, the efficacy of the COVID-19 mRNA vaccine’s lipid nanoparticle delivery system, and the presence of DNA fragments in these vaccines, it is essential to human health to assess the risks of contaminant DNA integration into human DNA,” Ladapo said Wednesday. “The FDA has provided no evidence that these risks have been assessed to ensure safety.”
Ladapo added: “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. 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. 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.
Providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines and treatment. 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.”
Ladapo said he will continue to assess research surrounding the risks of the mRNA shots and provide updates to Floridians.