Florida State Surgeon General Dr. Joseph A. Ladapo has called for a halt in the use of COVID-19 mRNA vaccines produced by Pfizer and Moderna, citing concerns over the presence of DNA fragments within these vaccines and the lack of evidence that federal regulators have fully assessed related safety risks.
On December 6, 2023, Dr. Ladapo sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf and Centers for Disease Control and Prevention (CDC) Director Dr. Mandy Cohen raising questions about nucleic acid contaminants in the approved mRNA vaccines. He highlighted issues with lipid nanoparticle complexes used in vaccine delivery, as well as the presence of Simian Virus 40 (SV40) promoter/enhancer DNA.
According to Dr. Ladapo, lipid nanoparticles are effective at delivering mRNA into human cells but could also efficiently deliver contaminant DNA into those cells. The inclusion of SV40 promoter/enhancer DNA may increase the risk that this DNA integrates into human genetic material.
The press release references FDA guidance from 2007 regarding plasmid DNA vaccines, which noted theoretical risks such as interference with oncogenes—genes capable of turning healthy cells cancerous—and possible chromosomal instability due to unintended integration of foreign DNA into various tissues throughout the body.
On December 14, 2023, the FDA responded in writing but did not provide evidence that it had conducted specific assessments on the risk of DNA integration for these vaccines. Instead, according to Dr. Ladapo, "The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed. Instead, they pointed to genotoxicity studies – which are inadequate assessments for DNA integration risk. In addition, they obfuscated the difference between the SV40 promoter/enhancer and SV40 proteins, two elements that are distinct."
He further stated: "DNA integration poses a unique and elevated risk to human health and to the integrity of 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. 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."
Dr. Ladapo urged providers concerned about patient health risks associated with COVID-19 "to prioritize patient access to non-mRNA COVID-19 vaccines and treatment." He added: "It is my hope that, in regard to COVID-19, the FDA will one day seriously consider its regulatory responsibility to protect human health, including the integrity of the human genome."
The Florida Department of Health says it will continue reviewing research on this issue and update residents accordingly.
For more information about public health efforts in Florida visit www.FloridaHealth.gov.