FDA official shames FL surgeon general for raising 'DNA contamination' concerns in COVID vaccines
Peter Marks cites "ongoing proliferation of misinformation and disinformation about these vaccines" as causing lowered uptake and more deaths in response to Joseph Ladapo letter.
Questioning the purity of mRNA COVID-19 vaccines is tantamount to spreading disinformation that kills people, the FDA's top vaccines official not so subtly implied to Florida Surgeon General Joseph Ladapo this week.
Ladapo notified FDA Commissioner Robert Califf and CDC Director Mandy Cohen Dec. 6 of recent research awaiting peer review that found "DNA fragments" in both Pfizer and Moderna vaccines from Ontario, Canada.
The "lipid nanoparticle delivery system" in mRNA technology may be an "equally efficient vehicle for delivering contaminant DNA into human cells," Ladapo wrote. He asked if FDA standards for "residual DNA" consider LNP delivery and whether the agencies had evaluated "the risk of DNA integration in reproductive cells."
The FDA responded Thursday in bold: "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."
Peter Marks, director of the Center for Biologics Evaluation and Research, said it would be "quite implausible" for "residual small DNA fragments" to make it "intact" all the way into chromosomal DNA. "Pharmacovigilance data in hundreds of millions of individuals also indicate no evidence indicative of genotoxicity."
He wrote again in bold, introducing an explanation of the manufacturing process: "Perpetuating references to this information about residual DNA without placing it within the context of the manufacturing process is misleading."
Marks subtly shamed Ladapo for even raising the issue. "The challenge we continue to face is the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake," he wrote.
"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 concluded.