In response to a letter in which Florida Surgeon General Joseph Ladapo noted the detection of DNA fragments in mRNA COVID-19 vaccines, Peter Marks, director of the Center for Biologics Evaluation and Research at the The U.S. Food and Drug Administration emphasized the FDA’s view that the shots are safe and effective.
“I am writing to address the recent discovery of host cell DNA fragments within the Pfizer and Moderna COVID-19 mRNA vaccines,” Ladapo said in his letter FDA Commissioner Robert Califf and CDC Director Mandy Cohen.
“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 the delivery of mRNA from COVID-19 vaccines to human cells and therefore may be an equally efficient vehicle for delivering contaminating DNA to human cells. The presence of promoter/enhancer DNA of SV40 may also represent a unique and major risk of DNA integration into host cells,” Ladapo wrote.
He also noted that “it is essential for human health to evaluate the risks of the integration of contaminating DNA into human DNA.”
But in responding to Ladapo, Marks conveyed the FDA’s claim that vaccines are safe and said “misinformation” causes “vaccine hesitancy that reduces vaccine acceptance.”
“We would like to make clear that, based on a thorough evaluation of the entire manufacturing process, the FDA is confident in the quality, safety and effectiveness of COVID-19 vaccines. The agency’s risk-benefit assessment and surveillance “Continued safety data demonstrate that the benefits of their use outweigh their risks. Additionally, with more than one billion doses of mRNA vaccines administered, no safety concerns related to residual DNA have been identified,” Marks wrote.
“No SV40 protein is encoded or present in the vaccines. First, it is quite unlikely that small residual DNA fragments located in the cytosol can reach the nucleus through the nuclear membrane present in intact cells and then be incorporated into the Chromosomal DNA,” Marks wrote. “In addition, animal studies using the modified mRNA and lipid nanoparticles together that constitute the vaccine, including small amounts of residual DNA fragments left after DNase treatment during manufacturing, have been performed and demonstrate no evidence of genotoxicity.” of the vaccine. Pharmacovigilance data on hundreds of millions of individuals also do not indicate evidence of genotoxicity.”
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