Topline
Controversial Florida Surgeon General Joseph Ladapo called for a halt of mRNA Covid-19 vaccines Wednesday, citing widely disputed concern about residual DNA contaminants in the vaccine integrating with human DNA and causing health risks, despite the FDA’s debunking of those concerns.
FILE – A health worker administers a dose of COVID-19 vaccine during a vaccination clinic in … [+] Reading, Pa. (AP Photo/Matt Rourke, File)
Key Facts
Ladapo referenced his Dec. 6 letter to both the Food and Drug Administration and Centers for Disease Control and Prevention, in which he raised concerns about the presence of “nucleic acid contaminants” that he worried may “pose a unique and heightened risk of DNA integration into host cells,” a concern that regulators have maintained is unfounded.
In a Dec. 14 response to Ladapo, Peter Marks, the director of the FDA’s center for biologics evaluation and research, reiterated that mRNA Covid vaccines are safe and that “no safety concerns related to residual DNA have been identified.”
Marks says it’s “quite implausible” that residual DNA left over from the manufacturing of the vaccine could find its way into the nucleus of cells, citing studies conducted on animals that demonstrated “no evidence of genotoxicity from the vaccine.”
He also noted that no SV40 proteins—which have long been the center of unfounded concerns about vaccine safety—are encoded for or are present in the vaccines, and that “with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”
Ladapo, however, said he called for a halt on mRNA Covid-19 vaccines because the FDA response did not “provide data or evidence” that the agency conducted “DNA integration assessments” he claims the FDA itself recommended in guidance issued in 2007.
But the Dec. 14 FDA letter mentions in a footnote that the 2007 guidance Ladapo refers 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.”
Crucial Quote
“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 his Dec. 14 letter, adding that perpetuating otherwise is “misleading.”
Key Background
With Wednesday’s pushback against the vaccine, Ladapo remains an outlier among public health officials in the U.S. At Ladapo’s urging, Florida became the first state in the U.S. to break with the CDC and recommend against the Covid-19 vaccine for healthy children in 2022. Ladapo is well-known as a Covid-19 vaccine skeptic who also generated some controversy after Politico reported that he altered a state-driven study on the vaccine to make cardiac deaths appear more likely. Ladapo has rejected that characterization of the edits in the study, telling Politico that revisions are a normal part of assessing surveillance data and that he has the expertise to make those revisions appropriately. In Ladapo’s most recent letter, he raised concern about a specific contaminant substance called SV40, or Simian Virus 40, promoter/enhancer DNA. Experts have said that while the vaccine utilizes molecules derived from SV40, the actual virus is not present and the molecules are safe.
Contra
In response to the FDA’s assertion about the SV40 molecules, Ladapo, however, claimed that the FDA was “obfuscating” between the SV40 proteins, and “SV40 promoter/enhancer DNA,” two different materials. He also cited a preprint, non-peer-reviewed study from October that claimed to have found DNA fragments in mRNA vaccines.
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