by Dr. Peter McCullough, America Outloud:
Dr. Joseph A. Ladapo is a Harvard-trained MD, PhD, and arguably one of the top experts on COVID-19 in the world. Prior to the Florida Surgeon General appointment, Dr. Ladapo was in academic practice at UCLA and published with myself, Dr. John McKinnon, and Dr. Harvey Risch on the efficacy of early hydroxychloroquine in acute COVID-19.
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On December 6th, 2023, State Surgeon General Dr. Joseph A. Ladapo sent a letter to the US Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf and Center for Disease Control and Prevention (CDC) Director Dr. Mandy Cohen regarding questions pertaining to the discovery of DNA process-related impurities found in the Pfizer and Moderna COVID-19 mRNA vaccines.
Ladapo’s concerns center around lipid nanoparticles laced with Simian Virus 40 (SV40) promoter/enhancer/origin of insertion DNA sequences widely distributed through the body. SV40 is a known promoter of proto-oncogenes.
The 2007 FDA’s Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (Guidance for Industry) outlines important considerations for vaccines that use novel methods of delivery regarding DNA integration, specifically:
- 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.
The FDA provided a written response on December 14, 2023, indicating the sponsors had NOT addressed risks outlined by the FDA itself in 2007. Because the FDA failed to handle these concerns, Dr. Ladapo has released the following statement:
The FDA’s response does not provide data or evidence that the DNA integration assessments it recommended itself have been performed. Instead, it pointed to genotoxicity studies – which are inadequate assessments for DNA integration risk. In addition, it 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, 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.
Ladapo called for a halt in Pfizer and Moderna mRNA COVID-19 vaccination. However, he did not recall the non-genetic Spike-protein antigen Novavax vaccine. The Bio-Pharmaceutical complex does not promote Novavax largely because Weber Shandwick has a PR contract with the CDC vaccine office to promote only Pfizer and Moderna. Senator Rand Paul has called out this conflict of interest and obvious paid favoritism for mRNA over the safer but equally ineffective Novavax product.
I wonder if Pfizer and Moderna were halted, would our government switch to the promotion of Novavax, or would they continue to let the smaller company languish?
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