Florida Surgeon General Dr. Joseph A. Ladapo has reached out to U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, seeking clarification on the presence of host cell DNA fragments in Pfizer and Moderna’s mRNA COVID-19 vaccines.
On December 6, Dr. Ladapo wrote to FDA Commissioner Califf and CDC Director Mandy Cohen, urging greater transparency regarding the potential integration of DNA into the human genome—a matter with potentially significant implications.
The Florida Public Health Integrity Committee discussed these concerns on November 14, 2023, and Ladapo urged the FDA to consider their findings. Additionally, he reminded Califf of a prior communication sent on May 10, 2023, which had not yet received a response.
On May 10, Ladapo wrote a letter to Califf and former CDC Director Rochelle Walensky concerning the potential risks associated with the experimental COVID-19 vaccines.
The letter reads:
Your ongoing decision to ignore many of the risks associated with mRNA COVID-19 vaccines, alongside your efforts to manipulate the public into thinking they are harmless, have resulted in deep distrust in the American health care system. Beginning with Operation Warp Speed, and possibly to be continued with an additional $5 billion investment in Project NextGen, the federal government has relentlessly forced a premature vaccine into the arms of the American people with little to no concern for the serious adverse ramifications.
…
Data are unequivocal: After the COVID-19 vaccine rollout, the Vaccine Adverse Events Reporting System (VAERS) reporting increased by 1,700%, including a 4,400% increase in life-threatening conditions. We are not the first to observe such a trend. Dismissing this pronounced increase as being solely due to reporting trends is a callous denial of corroborating scientific evidence also pointing to increased risk and a poor safety profile. It also fails to explain the disproportionate increase in life-threatening adverse events for the mRNA vaccines compared to all adverse events.
In the recent letter, Ladapo raised concerns about potential nucleic acid contaminants in Pfizer and Moderna’s COVID-19 mRNA vaccines. He specifically highlighted those in combination with lipid nanoparticles and the identified Simian Virus 40 (SV40) promoter/enhancer DNA.
“Lipid nanoparticles are an efficient vehicle for delivery of the mRNA in the COVID-19 vaccines into human cells, and may therefore be an equally efficient vehicle for delivering contaminant DNA into human cells. The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk of DNA integration into host cells,” was written in the letter.
The FDA guidelines from 2007 caution about the potential for DNA integration affecting oncogenes and leading to chromosomal instability.
The COVID-19 mRNA vaccines, utilizing a lipid nanoparticle delivery system, seemingly increase the risk for DNA fragment integration into the human genome.
The letter asserts:
- DNA integration could theoretically impact a human’s oncogenes – the genes which can transform a healthy cell into a cancerous cell.
- DNA integration may result in chromosomal instability.
- The Guidance for Industry discusses biodistribution of DNA vaccines and how such integration could affect unintended parts of the body including blood, heart, brain, liver, kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, the site of administration and subcutis at injection site.
Surgeon General Ladapo’s letter wrapped up with three relevant questions for the FDA:
- Have drug manufacturers evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from the mRNA COVID-19 vaccines alongside the additional risk of DNA integration from the lipid nanoparticle delivery system and SV40 promoter/enhancer? Has FDA inquired any information from the drug manufacturers to investigate such risk?
- Do current FDA standards for acceptable and safe quantity of residual DNA (present as known contaminants in biological therapies) consider the lipid nanoparticle delivery system for the mRNA COVID-19 vaccines?
- Considering the potentially wide biodistribution of mRNA COVID-19 vaccines and DNA contaminants beyond the local injection site, have you evaluated the risk of DNA integration in reproductive cells with respect to the lipid nanoparticle delivery system?
Considering the extensive use of these vaccines, Ladapo pressed for a prompt response.
He asked for written responses by December 13, 2023, emphasizing that transparency on this matter was crucial for both the American people and the scientific community to inform their decisions about the vaccines.
You can read the full letter here.
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