Joseph A. Ladapo, MD, PhD-ASTHO, calls for the halt of these vaccines; however, the FDA disagrees and says that “misinformation and disinformation about these vaccines…results in vaccine hesitancy.”
On December 6, 2023, Florida's State Surgeon General, Joseph A. Ladapo, MD, PhD, addressed a letter to the Commissioner of the United States Food and Drug Administration (FDA), Robert M. Califf, MD, and the Director of the CDC, Mandy Cohen, MD, MPH. The letter raised critical concerns about the safety assessments and the discovery of numerous DNA fragments per dose in the Pfizer and Moderna COVID-19 mRNA vaccines. The FDA responded that the “ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake” and could cost lives.
Ladapo's primary concern revolved around the presence of nucleic acid contaminants in these approved vaccines. The vaccines employ lipid nanoparticle complexes as efficient carriers to deliver mRNA into human cells. However, there's growing apprehension that these nanoparticles may also facilitate the transmission of contaminant DNA into human cells. Additionally, the vaccines contain Simian Virus 40 (SV40) promoter/enhancer DNA, which raises the potential risk of DNA integration into human cells.
The study that notes the fragments found in the mRNA vaccines states, “These data demonstrate the presence of billions to hundreds of billions of 62 DNA molecules per dose in these vaccines.… With several obvious limitations, we urge that our work is replicated under forensic 71 conditions and that guidelines be revised to account for highly efficient DNA transfection 72 and cumulative dosing.”
The FDA issued in 2007 its nonbinding guidance titled "Considerations for Plasmid DNA Vaccines for Infectious Disease Indications." This guidance underscored the importance of assessing DNA integration risks for vaccines using novel delivery methods. Specifically, it highlighted the theoretical possibility of DNA integration affecting oncogenes, leading to the transformation of healthy cells into cancerous ones, as well as the potential for chromosomal instability.
The guidance emphasized the significance of studying the biodistribution of DNA vaccines. The integration of these vaccines could have an impact on various unintended parts of the body such as the blood, heart, brain, liver, kidneys, bone marrow, ovaries/testes, lungs, draining lymph nodes, spleen, the site of administration, and subcutaneous tissues at the injection site. The guidance recommends “that the sensitivity of the assay be sufficient to quantify <100 copies of plasmid per microgram of host DNA. A claim of “non-persistence” requires that the amount of the plasmid at each site falls below this limit of quantification.”
Ladapo says that the FDA failed to provide any evidence that DNA integration assessments had been conducted to address the risks they themselves had recognized in 2007 in a written response on December 14, 2023. This lack of transparency and failure to assess the potential risks of contaminant DNA integration into human DNA is noted and concerning to Ladapo.
However, the FDA’s response states, “In response to the question regarding potential genotoxicity of the mRNA COVID-19 vaccines: No SV40 proteins are encoded for or are present in the vaccines. On first principle, it is quite implausible that the residual small DNA fragments located in the cytosol could find their way into the nucleus through the nuclear membrane present in intact cells and then be incorporated into chromosomal DNA.2 Additionally, studies have been conducted in animals using the modified mRNA and lipid nanoparticle together that constitute the vaccine, including the minute quantities of residual DNA fragments left over after DNAse treatment during manufacturing, and demonstrate no evidence for genotoxicity from the vaccine. Pharmacovigilance data in hundreds of millions of individuals also indicate no evidence indicative of genotoxicity.”
The FDA’s response gives a “general explanation of the manufacturing process of these vaccines.”
In response, Ladapo expressed his concerns in a statement. “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 noted, in the press release, that he is committed to maintaining transparency and scientific integrity by continuously assessing research related to these risks and providing ongoing updates to the people of Florida.
The FDA’s response stated, “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.”