NBC6’s Sheli Muniz has what you need to know about the new COVID-19 vaccine.
Florida Surgeon General Joseph Ladapo is urging residents in the Sunshine State to stop getting the Pfizer and Moderna mRNA COVID vaccines over what he says are DNA-related safety concerns.
Over time, the U.S. Food and Drug Administration has reiterated that its research shows the vaccines are safe and outweigh the health risks associated with COVID.
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But Ladapo's call for a halt in vaccination comes weeks after he issued a letter to the FDA last month, which questioned the safety and efficacy of the vaccines and whether the mRNA shots could possibly deliver DNA contaminants into human cells.
“These vaccines are not appropriate for use in human beings,” said Ladapo in a recent statement released by the Florida Department of Health.
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On December 14, the FDA provided a written response where the director of the FDA’s Center for Biologics Evaluation and Research Peter Marks, reported that a DNA virus was not present in the shots and that studies did not find "genotoxicity from the vaccine.”
Ladapo raised his concerns again Wednesday, saying that the “FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed," and that the integration poses a “unique and elevated risk to human health."
In his letter, Marks said the 2007 FDA guidance Ladapo referred to was developed for “DNA vaccines themselves, not for DNA as a contaminant in other vaccines and is not applicable to the mRNA COVID-19 vaccines," and that it’s quite implausible” that any residual DNA fragments from the COVID vaccines could find its way into a cell’s nucleus and “be incorporated into chromosomal DNA.”
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He also said that reproductive toxicology studies found “no concerns” with the Pfizer and Moderna vaccines and that global surveillance data on more than 1 billion doses of vaccines administered show “nothing to indicate harm to the genome."
The FDA doubled down and said that they wanted “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."
Ladapo, however, doesn’t think the FDA has properly assessed the vaccines.
The U.S. Centers for Disease Control and Prevention also says that the shots are safe and effective and is recommending the vaccines for everyone 6 months and older.
But Florida's surgeon general does not suggest people under 65 get the vaccine and recommends they speak to their doctor before getting the shot.
"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. 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," the FDA said in a statement Thursday. "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."
The CDC estimates that about 11% of adults and about 6% of kids in Florida have received the new shots.
