Against the recommendations of federal health agencies, Florida Surgeon General Dr. Joseph Ladapo has called for a "halt in the use of COVID-19 mRNA vaccines."
In a statement released Wednesday by the Florida Department of Health, Ladapo referred to a Dec. 6 letter to the U.S. Food and Drug Administration in which he raised concerns about "nucleic acid contaminants" in the Pfizer and Moderna COVID-19 mRNA vaccines, and the "unique risks posed by DNA integration."
The FDA had refuted Ladapo's concerns in a Dec. 14 response and stated 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."
The FDA further stated that "with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified." The U.S. accounts for more than 670 million doses.
However, in Wednesday's statement iterating his concerns, Ladapo called the FDA's explanation inadequate and said "the FDA has provided no evidence that these risks have been assessed to ensure safety."
In an email to WUSF, the FDA reiterated its confidence in the COVID-19 vaccines and described Ladapo's claims as misleading.
"The FDA stands firmly behind the safety, effectiveness and manufacturing quality of the approved and authorized COVID-19 vaccines, and respectfully disagrees with the Florida Surgeon General’s opinion.
"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," said FDA spokesperson Cherie Duvall-Jones.
Unlike some vaccines, messenger RNA or mRNA vaccines do not contain pieces of the virus. Instead, it gives cells instructions for how to make the spike protein found on the surface of the coronavirus, prompting the body to create antibodies that will fight the virus if infected.
While this type of vaccine is new, it is not unknown, according to John Hopkins Bloomberg School of Public Health. Decades of research have preceded the COVID-19 pandemic and the vaccines "do not affect or interact with your DNA."
In the FDA's December response to Ladapo, Peter Marks, director of the Center for Biologics Evaluation and Research, stated that it was implausible "that the minute amounts of small DNA fragments present could find their way into the nucleus of these cells."
Past controversy
Appointed in 2021, Ladapo has drawn criticism from federal health officials and the scientific community for his statements on vaccines and the COVID-19 pandemic.
Florida became the first state to recommend against the COVID-19 vaccine for healthy children, contrary to the Centers for Disease Control and Prevention's recommendation that most Americans 6 months and older receive booster shots.
In March 2023, the CDC and FDA issued a joint letter stating that Ladapo's claims of increased health risks related to the COVID-19 vaccine were "incorrect, misleading and could be harmful to the American public."
The letter further stated, "focusing on adverse events in the absence of causal association and without the perspective of countervailing benefits is a great disservice to both individuals and public health. ... Serious adverse events from COVID-19 vaccines are rare and are far outweighed by the benefits of these vaccines for every age group"
A Tampa Bay Times analysis also found that Ladapo recommended that young men should not get the vaccine due to risk of cardiac-related deaths after Florida health officials had omitted key COVID-19 vaccine data. A group of epidemiologists and professors called the guidance "badly flawed."
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