Florida State Surgeon General Dr. Joseph A. Ladapo is calling on U.S. health agencies to halt the use of COVID-19 mRNA vaccines over concerns there could be nucleic acid contaminants and Simian Virus 40 (SV40) promoter/enhancer DNA in Pfizer and Moderna’s vaccines.
SV40 is a monkey virus that was accidentally administered to humans through SV40-contaminated vaccines, mainly polio vaccines, between 1955 and 1963—and is a known oncogenic DNA virus that causes brain and bone cancers, malignant mesothelioma, and lymphomas in laboratory animals and humans.
In a Dec. 6 letter, Dr. Ladapo asked Dr. Mandy Cohen, director of the Centers for Disease Control and Prevention, and commissioner Dr. Robert Califf of the U.S. Food and Drug Administration (FDA) about the safety assessments performed by drug manufacturers and billions of DNA fragments per dose discovered in Pfizer and Moderna COVID-19 mRNA vaccines.
Specifically, Dr. Ladapo wanted to know whether Pfizer and Moderna or the FDA evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from mRNA COVID-19 vaccines—with the added risk of DNA integration from the lipid nanoparticle (LNP) delivery system and SV40—and what effects this might have if DNA contaminants went beyond the injection site to other areas of the body.
LNPs that deliver mRNA from COVID-19 vaccines into human cells may be an “equally efficient vehicle” for delivering contaminant DNA into human cells, Dr. Ladapo said in a January press release. Because the simian DNA tumor virus SV40 promotes/enhances DNA, it could heighten the risk of DNA integration into human cells.
In its Dec. 14 response to Dr. Ladapo’s inquiries, the FDA provided no evidence that DNA integration assessments had been conducted to address risks outlined by the agency in its previous guidance.
The FDA in 2007 published guidance on regulatory limits for DNA in vaccines using a novel method of delivery, such as that used by mRNA vaccines, over concerns DNA could be integrated into human cells.
In its guidance, the FDA acknowledged that DNA integration—where the DNA is carried into human cells as LNPs do with the mRNA in COVID vaccines—could theoretically impact a human’s oncogenes responsible for turning healthy cells into cancerous cells, that DNA integration may result in chromosomal instability, and that biodistribution to other parts of the body such as the blood, heart, brain, liver kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, and the site of administration could have unintended consequences.
In a press release, Dr. Ladapo stated:
“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.
Unfortunately for the humans forced to get vaccinated, neither the pharmaceutical companies nor regulatory agencies looked into what might happen if COVID-19 vaccines altered human DNA and what effect this would have on a woman’s fertility, male sperm, a developing fetus, or cancer rates. Given what’s come forward through the disclosure of court documents, one must wonder whether the ignorance was willful.
Dr. Ladapo previously issued guidance on Sep. 13, 2023, against COVID-19 boosters for individuals under 65 and has expressed numerous concerns about the safety and efficacy of COVID-19 vaccines.