Florida State Surgeon General Dr. Joseph A. Ladapo is calling for a halt of the use of COVID-19 mRNA vaccines.
Ladapo sent a letter on Dec. 6 to Dr. Robert M. Califf, commissioner of the U. S. Food and Drug Administration (FDA), and the director of the Centers for Disease Control and Prevention (CDC), Dr. Mandy Cohen, in relation to issues similar to protection. testing and the discovery of billions of DNA fragments compatible with the Pfizer and Moderna mRNA COVID-19 vaccines.
Ladapo raised considerations about nucleic acid contaminants in Pfizer and Moderna’s approved COVID-19 mRNA vaccines, in the presence of lipid nanoparticle complexes and simian virus 40 (SV40) promoter/enhancer DNA.
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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 would possibly also pose a unique and greater threat to DNA integration in human cells.
In 2007, the FDA published guidance on regulatory limits for DNA vaccines in the Guidance for Industry: Plasmid DNA Vaccine Considerations for Infectious Disease Indications (Guidance to Industry). In this guidance for industry, the FDA highlights considerations for vaccines that use new delivery strategies related to DNA integration, in particular:
On December 14, 2023, the FDA provided a written response that offered no evidence that DNA integration testing had been conducted to address the dangers described by the FDA itself in 2007.
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Considering the FDA’s popularity of the dangers posed by DNA integration, the efficacy of the COVID-19 mRNA vaccine’s lipid nanoparticle delivery system, and the presence of DNA fragments in those vaccines, it is critical to human fitness to assess the dangers related to contamination. Integration of DNA into human DNA.
The FDA has not provided any evidence that the safety of those hazards has been evaluated.
Ladapo issued the following statement:
“The FDA’s reaction provides no knowledge or evidence that the DNA integration tests were performed by the FDA itself. Instead, they pointed to genotoxicity studies, which are insufficient evidence of the threat of DNA integration. In addition, they obscured the difference between the SV40 promoter/enhancer and SV40 proteins, two separate elements.
DNA integration poses a unique and ultimate threat to human fitness and the integrity of the human genome, adding the threat that DNA embedded in sperm or gamete eggs could be passed on to the offspring of COVID-19 mRNA vaccine recipients. mRNA COVID-19 vaccines have been evaluated, but those vaccines are suitable for use in humans.
Providers involved in COVID-19-related patient health hazards deserve to prioritize patient access to non-mRNA COVID-19 vaccines and treatments. I hope that when it comes to COVID-19, one day the FDA will seriously fulfill its regulatory duty to protect humans. fitness, adding the integrity of the human genome.
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