TALLAHASSEE, Fla. – Today Florida Surgeon General Dr. Joseph Ladapo called for a “halt to the use of mRNA COVID-19 vaccines” in a press release and X thread. In a statement posted on X, Ladapo wrote, “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 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.”
The announcement follows an exchange of letters in December between Ladapo and the US Food and Drug Administration (FDA). As detailed in our exclusive interview, Ladapo’s letter asked questions about a recent preprint documenting the detection of billions of DNA fragments per dose in the approved Pfizer and Moderna COVID-19 mRNA vaccines; Simian Virus 40 (SV40) promoter/enhancer DNA was also found in Pfizer vials. In the letter, Dr. Ladapo points out that the vaccines use lipid nanoparticles to efficiently deliver mRNA into human cells, so the vaccines may be equally efficient at delivering the DNA contaminants into human cells.
The risks of this contamination could include the integration of these DNA fragments with human DNA, changes to our genes that could be passed down to offspring, and the development of cancer because the genes within a cell control whether the cell is healthy or cancerous.
The response from Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research at the FDA, stated that “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 further stated that “No SV40 proteins are encoded for or are present in the vaccines…Any contamination with residual DNA fragments is monitored routinely as a product specification…[and] reproductive toxicology studies have been conducted to evaluate the mRNA COVID-19 vaccines and have found no concerns.”
Marks’ letter provides information about the manufacturing process for the products before concluding, “We stand firmly behind our regulatory decision making with the authorizations and approvals of the COVID-19 vaccines, which have a highly favorable safety profile, and which have saved, and continue to save, many lives. The challenge we continue to face is the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake. Given the dramatic reduction in the risk of death, hospitalization and serious illness afforded by the vaccines, lower vaccine uptake is contributing to the continued death and serious illness toll of COVID-19.”
In today’s press release, Ladapo wrote that Marks’ letter provided “no evidence that DNA integration assessments have been conducted to address risks outlined by the FDA themselves in 2007…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.”
Because of this, Dr. Ladapo writes, “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…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.”
The letter recommends that providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines and treatment.
Republished from Alachua Chronicle
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