Florida Surgeon General Flags DNA Integration Risks in Pfizer and Moderna COVID-19 Vaccines, Urges FDA Action

State Surgeon General Dr Joseph A. Ladapo sent a letter to the United States Food and Drug Administration (FDA) Commissioner Dr Robert M. Califf and Center for Disease Control and Prevention (CDC) Director Dr Mandy Cohen regarding questions about the safety assessments and the discovery of DNA fragments in the Pfizer and Moderna COVID-19 mRNA vaccines, according to a news release from the Florida Department of Health.

The Surgeon General outlined concerns regarding nucleic acid contaminants in the approved Pfizer and Moderna COVID-19 mRNA vaccines. He was particularly concerned about the presence of lipid nanoparticle complexes and Simian Virus 40 (SV40) promoter/enhancer DNA. These lipid nanoparticles are effective in delivering the mRNA of the vaccine into human cells, but they may also deliver contaminant DNA. SV40 promoter/enhancer DNA increases the risk of integration into human cells. This poses a unique and higher risk.

On December 14, 2023, the FDA provided a written response stating that there was no evidence that DNA integration assessments had been conducted on the vaccines.

As a result, Dr Ladapo released the following statement:

“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.

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.

Providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines and treatment. It is my hope that, regarding COVID-19, the FDA will one day seriously consider its regulatory responsibility to protect human health, including the integrity of the human genome.”

The State Surgeon General will continue to assess research surrounding these risks and provide updates on the matter.

Reference

Florida Health. Florida state Surgeon General calls for halt in the use of COVID-19 mRNA vaccines. Published January 3, 2024. Accessed January 19, 2024. https://www.floridahealth.gov/newsroom/2024/01/20240103-halt-use-covid19-mrna-vaccines.pr.html