Florida State Surgeon General Dr. Joseph Ladapo is calling on healthcare providers to halt the use of COVID-19 mRNA vaccines, citing purported health risks labeled "misinformation" by federal officials.
In a bulletin issued Wednesday, Ladapo claimed the U.S. Food and Drug Administration (FDA) has not shown evidence that coronavirus vaccines manufactured by Pfizer and Moderna have been assessed for "nucleic acid contaminants" that could cause cancer. Disputing claims by the FDA that such risk is "implausible," Ladapo called for an immediate stoppage to the use of the approved mRNA COVID-19 vaccines.
"I am calling for a halt to the use of mRNA COVID-19 vaccines," the Florida surgeon general said in a statement.
"The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have always played it fast and loose with COVID-19 vaccine safety, but their failure to test for DNA integration with the human genome — as their own guidelines dictate — when the vaccines are known to be contaminated with foreign DNA is intolerable," he asserted.
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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.
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"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."
Marks went on to say that the chief challenge regulators face "is the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake."
However, Ladapo contends FDA did not answer his questions.
"The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed," the surgeon general 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."
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"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."
The FDA did not immediately respond to a request for comment.
In a statement, Pfizer reiterated that regulatory agencies across the globe have authorized the use of its mRNA vaccine and found it safe and effective.
"These authorizations are based on robust and independent evaluation of the scientific data on quality, safety and efficacy, including our landmark phase 3 clinical trial. Data from real world studies complement the clinical trial data and provide additional evidence that the vaccine provides effective protection against severe disease," Pfizer told Fox News Digital.
"Over the course of this deadly pandemic, mRNA vaccines have saved hundreds of thousands of lives, tens of billions of dollars in health care costs, and enabled people worldwide to go about their lives more freely. We have delivered more than 4 billion vaccines to 181 countries and territories in every region of the world."
Moderna did not immediately respond to a request for comment.
Ladapo has previously clashed with the FDA and CDC. In March, the health agencies accused him of misleading the public on COVID-19 vaccine side effects by highlighting rare adverse events and downplaying the benefits of vaccination.
