Florida’s surgeon general told the FDA that COVID-19 vaccines aren’t safe. The FDA calls that misinformation

The U.S. Food and Drug Administration fought back on Friday against what it calls “the proliferation of misinformation” by Florida’s Surgeon General Joseph Ladapo about the safety of COVID-19 vaccines.

In a letter earlier this month to the FDA, Ladapo had questioned the agency’s drug approval and raised alarms about what he sees as the risk of potential cancer posed by COVID-19 mRNA vaccines. Ladapo, the leader of Florida’s health department, said he believed the drug delivery system used by mRNA vaccines could be an “efficient vehicle for delivering contaminant DNA into human cells.”

But a top researcher with the FDA released a public response to Ladapo on Friday saying the Surgeon General’s scientific assertion regarding the cancer risk is “implausible.”

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research for the FDA, said the premise asserted by Ladapo that DNA contaminant could cause cancer in vaccine recipients is not scientifically accurate because there is no way that minute amounts of DNA fragments could find their way into the nucleus of human cells where DNA resides.

He added that this type of disinformation results in vaccine hesitancy.

“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,” Marks wrote. Indeed, only 11% of Floridians have received an updated COVID-19 booster, despite the state’s large population of elderly who are most at risk for poor outcomes. Even more, only about a third of the state’s vulnerable long-term care population has had the updated shot, according to the Centers for Disease Control and Prevention.

“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 the response to Ladapo. “Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”

In his Dec. 6 letter, Ladapo had pressed the FDA and CDC to answer three questions by Dec. 13: Was the risk of DNA integration evaluated by drug manufacturers and provided to the federal agencies; did FDA standards take the COVID-19 vaccine’s delivery system into account; and was a risk evaluated of integration with reproductive cells beyond the local injection site?

Dr. Kawsar Talaat, an associate professor in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, says those three concerns have no scientific basis.

Her research expertise is in conducting clinical trials for a variety of vaccines to determine their safety and efficacy. “The COVID vaccine enters the outer part of cell and the RNA works there. It wouldn’t be possible for the DNA to integrate into the chromosomes since they are not even in same compartment,” she said. “Even if they were, the mechanism that allows that to happen is not included in the vaccine.”

Talaat said Ladapo overlooks how much research on the mRNA COVID-19 vaccines has taken place.

“There has not been a vaccine released into the population that has been under more scrutiny than the mRNA COVID vaccines,” she said. “There has not been any evidence thus far that there are any problems with integration with any DNA, or cancer as a result of the vaccines.”

Talaat said she just had a 40-year-old friend with a health condition die of COVID-19.

“These questions (raised by Ladapo) are designed to scare people rather than investigate true science,” she said. “What we do know is that COVID continues to kill thousands of people every month in the U.S. I think he is doing a disservice to the people of Florida by trying to scare them into not getting a vaccine that can be lifesaving.”

Ladapo did not respond by the end of the business day on Friday to the South Florida Sun Sentinel’s request for comment about the FDA letter.

This isn’t Ladapo’s first tussle with the FDA. In March, he was publicly rebuked by the FDA and CDC over his vaccine advice. Those agencies told him to stop disproportionately focusing public attention on the few instances of adverse effects from the COVID-19 vaccine. Ladapo previously has painted the COVID vaccines as dangerous and claimed there have been no clinical trials on the effects of the new booster on human beings, a statement that the manufacturers say is false.

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