FDA Guidance on Prophylactic DNA Vaccines: Analysis and Recommendations
(Snip) 3.4) Plasmid Integration issues
DNA is considered a contaminant of “conventional” (non-DNA) vaccines. Manufacturers typically minimize or remove extraneous DNA during the production process to minimize human exposure to potentially injurious material. Not surprisingly, concerns that plasmid DNA might integrate into the host genome, increasing the likelihood of malignant transformation, genomic instability, or cell growth dysregulation were raised when DNA vaccines were first proposed for clinical use [31;36;41]. Based on advice from the Vaccine's Advisory Committee, the FDA set guidelines designed to insure that the frequency of plasmid integration would be substantially lower than the spontaneous mutation rate [42].
For novel plasmids or methods of formulation and delivery, integration studies would be required when plasmid persists at levels exceeding 10,000 copies per ug of host DNA. This recommendation reflects the expectation that only a tiny fraction of persisting plasmid will integrate into the host genome, regardless of the method of delivery [45].
In evaluating the potential harm of plasmid integration, it should be noted that the risk of introducing plasmids with strong regulatory regions into the host genome far exceeds that associated with random point mutations [43;50]. Moreover, the technology used to detect plasmid persistence does not examine the frequency with which short fragments of plasmid integrate. In this context, sections of DNA as short as 7 bp can affect rates of integration or recombination.
200,000 billion per ? of host DNA. Can't say, but sounds like they used a lot of "Hopium" in the manufacture of the covid "Vaccines". "Don't worry, trust us...yah....it will be all right!"
Thanks Pete!