Dr. Joseph Ladapo discusses potential risks with the COVID-19 vaccine
Dr. Joseph Ladapo, Florida's surgeon general, on the risks associated with the COVID-19 vaccine for young men on 'Hannity.'
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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Florida Surgeon General Joseph Ladapo, left, and Florida Gov. Ron DeSantis attend a news conference in West Palm Beach, Florida, on Jan. 6, 2022. (Joe Cavaretta/Sun Sentinel/Tribune News Service via Getty Images)
The FDA said in a statement it "respectfully disagrees" with Ladapo's opinion.
"With over a billion doses of the mRNA vaccines administered and following very careful review of all the available scientific evidence, the FDA has not identified safety concerns related to the sequence of, or amount of, residual DNA," an FDA spokesperson told Fox News Digital.
"In general, while concerns have been raised previously as theoretical issues, the available scientific evidence regarding the mRNA vaccines strongly supports the conclusion that the vaccines are safe and effective and have a highly favorable profile of benefit to risk. Additionally, it is simply a fact that millions of lives have been saved because of the COVID-19 mRNA vaccines, which most Americans undergoing vaccination have received."
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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, on August 29, 2020. (REUTERS/Andrew Kelly/File Photo)
A top FDA official last month pushed back against Ladapo and what the FDA called "the proliferation of misinformation" on vaccine safety.
The Florida surgeon general had 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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A medical worker prepares a dose of the "Cominarty" Pfizer-Bivalent coronavirus disease (COVID-19) vaccine at a vaccination center in Nice as a new surge in the COVID-19 outbreak starts in France on Dec. 7, 2022. (REUTERS/Eric Gaillard)
"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 the 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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Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, gives an opening statement during a Senate Health, Education, Labor and Pensions Committee hearing to discuss the ongoing federal response to COVID-19 in Washington, D.C., on May 11, 2021. (Getty Images)
"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 referenced its previous letter to Ladapo and said his comments were misleading.
"Perpetuating references to information about residual DNA in COVID-19 vaccines without placing it within the context of the manufacturing process and the known benefits of the vaccine is misleading," the agency said.
"As stated in the letter, the challenge we continue to face is the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake. Given the dramatic reduction in the risk of death, hospitalization and serious illness afforded by the vaccines, lower vaccine uptake is contributing to the continued death and serious illness toll of COVID-19."
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In a statement, Pfizer called Ladapo's claims false and reiterated that regulatory agencies across the globe have authorized the use of its mRNA vaccine and found it safe and effective.
"There is no evidence to support claims that the Pfizer-BioNTech COVID-19 vaccine contains plasmid DNA that could potentially impact a person’s DNA or be a theoretical cancer risk," a Pfizer spokesperson said.
"SV40 stands for Simian Virus 40. It is a naturally occurring virus and the virus itself is not included in either starting materials, plasmid DNA, or in the final product of the Pfizer-BioNTech COVID-19 vaccine. However, specific, non-infectious parts of the SV40 sequence, which are commonly used in the pharmaceutical industry are present in starting material used by Pfizer and BioNTech," the spokesman explained.
The Pfizer logo. (REUTERS/Dado Ruvic)
"The Pfizer-BioNTech COVID-19 vaccine has been reviewed by multiple regulatory authorities, including the EMA and U.S. Food and Drug Administration (FDA), and advisory bodies globally and has met all safety and quality control guidelines. These agencies approved our COVID-19 vaccine with established specifications for development and manufacturing, including a validated method for assessment of residual DNA outlined by the World Health Organization and FDA for biological products.
"It is important to note that similar quality standards regarding residual DNA are applied to other vaccines. Small amounts of residual DNA can be found in several approved vaccines, including influenza and hepatitis vaccines, which have been administered globally for more than 30 years," the spokesman added.
"Since its initial authorization for use in December 2020, the Pfizer-BioNTech COVID-19 vaccine has been administered to more than 1.5 billion people, has demonstrated a favorable safety profile in all age groups, and has helped protect against severe COVID-19 outcomes, including hospitalization and death."
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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.
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