FDA responds to Ladapo letter about DNA fragments detected in mRNA COVID-19 vaccines

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 U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, emphasized the FDA's view that the shots are safe and effective.

"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 noted in his letter to 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 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," Ladapo wrote.

He also noted that "it is essential to human health to assess the risks of contaminant DNA integration into human DNA."

But when responding to Ladapo, Marks conveyed the FDA's contention that the vaccines are safe and said that "misinformation and disinformation" causes "vaccine hesitancy that lowers vaccine uptake."

"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 benefitrisk 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," Marks wrote.

"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. "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."

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