Open letter from Joseph Ladapo to Robert M. Califf (FDA Commissioner) and Mandy Cohen (CDC Director).
"Dear Drs. Califf and Cohen, ...
[D]ebates over the safety and effectiveness of COVID-19 vaccines have been smeared as “hysteria” since their development – and yet as additional research is conducted, concerns continue to emerge. I have highlighted some of these concerns in a May 10, 2023 letter sent to you and former Centers for Disease Control and Prevention Director Rochelle Walensky. To date, no response has been received. In addition to my previous letter, I am writing to you to address the recent discovery of host cell DNA fragments within the Pfizer and Moderna COVID-19 mRNA vaccines.
This raises concerns regarding the presence of nucleic acid contaminants in the approved Pfizer and Moderna COVID-19 mRNA vaccines, particularly in the presence of lipid nanoparticle complexes, and
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...
In 2007, the FDA published guidance on regulatory limits for DNA vaccines in the Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (Guidance for Industry). This Guidance for Industry highlights important considerations for vaccines that use novel methods of delivery regarding DNA integration:
- 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."