The statement was issued in response to the reply he received to a letter he sent in December to the commissioner of the FDA, Dr. Robert Califf, and the director of the CDC, Dr. Mandy Cohen, asking whether any risk assessments have been conducted on the DNA in the vaccines integrating into human DNA.
He highlighted specific concerns about the SV40 promoter/enhancer region in the Pfizer jab. He also inquired whether they have carried out risk assessments on the integration of DNA in reproductive cells.
Although he did receive a response from a representative of the FDA's Center for Biologics Evaluation and Research, Dr. Peter Marks, he felt that they essentially brushed off his concerns. Moreover, they never mentioned any tests being conducted to assess whether DNA integration was occurring.
Dr. Ladapo recently appeared on Epoch TV's American Thought Leaders to explain the rationale behind his statement calling for the vaccines to be halted. He emphasized that there were already numerous safety concerns about mRNA vaccines, but the recent DNA contaminant discovery is “beyond the pale.”
He explained to host Jan Jekielek that DNA is actually a common contaminant in biological products, noting: “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.”
Because human cells can resist the entrance of DNA, there is normally no risk of damage to the cells’ DNA integrity. However, mRNA vaccines are different because they use lipid nanoparticles to deliver mRNA directly into the cells. This means the DNA contaminants may also enter the cells, and some scientists are worried that this vaccine DNA could integrate with the human genome.
Dr. Ladapo explained his frustration with the response officials gave him when he inquired about the testing for DNA integration: “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.”
While the mRNA vaccines from both Pfizer and Moderna have been found to contain DNA contaminants, the Pfizer vaccines pose another serious concern in the form of simian vacuolating virus 40, or SV40 promoter/enhancer DNA. This is a virus that has been known to cause cancer in some animals, and while the SV40 promoter/enhancer in the jabs only contains a small portion of the DNA rather than the full virus or its protein, there are still concerns that it poses an additional risk.
Dr. Ladapo reported that Dr. Marks said in his response that there were no SV40 proteins, but since his question was actually about the promoter/enhancer region and not the proteins, he believes he is simply trying to avoid answering the question.
He also told Jekielek that DNA integration of reproductive cells is a real concern with these vaccines because biodistribution studies performed on rats have indicated that mRNA vaccines are capable of accumulating in reproductive organs.
In his statement calling for a halt to COVID-19 vaccination using mRNA vaccines, Dr. Ladapo noted: “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."
He added: "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.”
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