Florida official takes aim at COVID vaccines with “misleading” claims, FDA says

Florida’s state surgeon general, Dr. Joseph Ladapo, is calling for doctors to stop recommending mRNA COVID-19 vaccines, citing alleged health risks promoted by anti-vaccine activists that federal health officials have already refuted as “implausible” and “misleading.”

In a bulletin posted Wednesday on the Florida Department of Health’s website, Ladapo raised concerns about “nucleic acid contaminants” found in the approved Pfizer and Moderna COVID-19 vaccines. He claimed this could deliver “contaminant DNA” into human cells and also raised concerns about cancer risk.

Ladapo alleges in his statement that “DNA integration poses a unique and elevated risk to human health” and 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.” He adds, “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.”

He urged providers to prioritize patient access to “non-mRNA COVID-19 vaccines and treatment.” (The COVID vaccine from Novavax, which rolled out in the fall, is a non-mRNA option. Monoclonal antibodies and Paxlovid treatments do not use mRNA either.)

Last month, the FDA responded to a letter from Ladapo in which he outlined the same concerns. Federal health officials refuted his claims as “quite implausible” and “misleading.”

“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,” the FDA said in its response. “The agency’s benefit-risk assessment and ongoing safety surveillance demonstrate that the benefits of their use outweigh their risks.”

“Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified,” the FDA said in its letter.

Dr. Céline Gounder, a CBS News medical contributor and editor-at-large for public health at KFF Health News, explains that Ladapo’s argument isn’t about the vaccine’s mRNA integrating into the human genome; instead, he’s suggesting “contaminant DNA (often present at trace amounts in biologics) might integrate, and that by doing so it might activate an oncogene (i.e. a gene that causes cancer),” she explains.

Anti-vaxxers call this “turbo cancer” — which doesn’t exist, Gounder said.

“There’s no evidence that any of this might happen or could happen,” Gounder said. “That said, formally proving that any biologic does NOT cause cancer is a multi-year process, because cancers typically develop over a long period. COVID, on the other hand, kills in weeks, and the mRNA vaccines prevent severe disease, hospitalization and death in that timeframe.”

Gounder also notes that DNA-based vaccines have been used for many years without links to cancer.

“DNA vaccines have never been associated with cancer development despite delivering orders of magnitude more DNA than is present as a contaminant in mRNA vaccines,” she says. “Trace amounts of DNA are present in pretty much every biologic used in medicine that is made in cell cultures, including monoclonal antibodies, some of which are used as cancer therapies. There will also be some trace levels of DNA in the other COVID vaccines, because they are made in cell cultures.”

She also points out, “Biologically speaking, mRNA can’t integrate into your DNA. mRNA vaccines are not gene therapy.”

This isn’t the first time a letter from Ladapo has resulted in a rebuttal from public health agencies.

In March, the Centers for Disease Control and Prevention called out more of Ladapo’s claims around the COVID-19 vaccines, calling them “incorrect, misleading and could be harmful to the American public.”

As for the benefits of the vaccines, researchers based in London have estimated that COVID vaccines saved nearly 20 million lives worldwide in their first year alone — including 1.9 million Americans who would have otherwise died in the pandemic — according to a study published in the Lancet Infectious Diseases journal in 2022.

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