On Jan. 3, the office of Florida Surgeon General Dr. Joseph Ladapo issued a statement calling for the halt in the use of COVID-19 mRNA vaccines, citing the recent discovery of DNA contaminants in the vaccine vials.
On the Jan. 12 episode of EpochTV’s “American Thought Leaders,“ Dr. Ladapo explained why he called for a halt, saying that while there are also safety concerns with the COVID mRNA vaccines linking them to a multitude of adverse events, the recent discovery is ”beyond the pale.”
“DNA is a common contaminant of many biological products,” he told the show’s host, Jan Jekielek. “We can use DNA to produce different drugs like insulin, other biologics—and that’s a wonderful innovation, and normally, that DNA doesn’t pose a problem.”
Human cells are resistant to DNA entry, and this prevents harming the integrity of the cell’s DNA.
However, since the mRNA vaccines use lipid nanoparticles, which deliver mRNA into the cells directly, DNA contaminants could also be able to enter the cells. Some scientists, like Dr. Ladapo, are concerned that the DNA from the vaccine may integrate with the human genome.
Prominent officials at the U.S. Food and Drug Administration (FDA) disagree.
On Dec. 6, Dr. Ladapo sent a letter to FDA commissioner Dr. Robert Califf and the U.S. Centers for Disease Control and Prevention (CDC) director, Dr. Mandy Cohen.
In his letter, he asked if there have been risk assessments of the vaccine DNA integrating into human DNA, especially regarding the controversial SV40 promoter/enhancer region found in Pfizer’s vaccine.
Other questions included whether risk assessments have been done on DNA integration in reproductive cells and if the current levels of DNA residuals are acceptable under the FDA’s standards.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, replied to Dr. Ladapo on Dec. 14.
“We’ve gotten … lengthy responses that don’t answer the question,” Dr. Ladapo said.
In his response, Dr. Marks wrote that DNA integration “is quite implausible,” adding that animal studies show “no evidence indicative for genotoxicity.”
No tests were mentioned that would assess if DNA integration is occurring.
Dr. Ladapo believes it would be reckless not to test for DNA integration, a potential risk once DNA enters the cell.
“Their position is, oh, no, it’s fine. Everything’s fine; safe and effective. That’s not only not good enough, but it’s completely unacceptable,” Dr. Ladapo said. “And that’s why I made that determination, and it’s absolutely the correct call.”
By Marina Zhang and Jan Jekielek
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