The Food and Drug Administration issued a response to Florida Surgeon General Joseph Ladapo’s letter claiming there were DNA fragments present in the mRNA COVID-19 vaccines.
Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said, “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. The agency’s benefit-risk assessment and ongoing safety surveillance demonstrate that the benefits of their use outweigh their risks. Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”
The director claimed that DNA fragments entering a cell’s nucleus are “quite implausible.”
“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,” Marks wrote in the response letter.
“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.”
Ladapo, who previously cautioned against the COVID-19 vaccines, wrote a letter to the FDA in early December questioning the inoculations.
“I am writing to you to address the recent discovery of host cell DNA fragments within the Pfizer and Moderna COVID-19 mRNA vaccines,” Ladapo said in the letter.
“This raises concerns regarding the presence of 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 host cells,” he explained.
