Florida Surgeon General Dr. Joseph Ladapo is calling for a “halt” in the use of mRNA COVID-19 vaccines over a health risk federal officials dispute.
In a Dec. 6 letter, Ladapo addressed his concerns “pertaining to the safety assessments and the discovery of billions of DNA fragments per dose of the Pfizer and Moderna COVID-19 mRNA vaccines” to the directors of the Food and Drug Administration and Centers for Disease Control and Prevention.
But federal officials have strongly disagreed with his assessment.
A top FDA official last month pushed back against Ladapo and what the FDA called "the proliferation of misinformation" on vaccine safety.
Ladapo raised concerns about the agency's approval of mRNA COVID-19 vaccines in a Dec. 6 letter to FDA Commissioner Dr. Robert M. Califf and CDC Director Dr. Mandy Cohen. His letter cited a pre-print study that, according to the surgeon general, showed there are "billions of DNA fragments per dose of the Pfizer and Moderna COVID-19 mRNA vaccines."
Pointing to FDA guidance on vaccines that "use novel methods of delivery regarding DNA integration," Ladapo questioned whether the Pfizer and Moderna mRNA vaccines had been assessed to meet FDA's standards, noting a potential risk of cancer.
In a written response, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, wrote that it is "implausible" that residual small DNA fragments could find their way into the nucleus of human cells and then alter DNA to cause cancer.
"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," Marks wrote in a Dec. 14 letter. "Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified." (Fox News)
But Ladapo said the FDA’s response did not adequately address his concerns.
“The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed,” he said in a statement. “Instead, they pointed to genotoxicity studies – which are inadequate assessments for DNA integration risk. In addition, they obfuscated the difference between the SV40 promoter/enhancer and SV40 proteins, two elements that are distinct.
“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,” Ladapo continued. “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.”
As always, Florida will put scientific integrity and the safety of our citizens above profit-fueled agendas.
— Joseph A. Ladapo, MD, PhD (@FLSurgeonGen) January 3, 2024
See my full recommendation here: https://t.co/PkonLzaCUL
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