One of the most common questions I am asked from the unvaccinated stems from concerns over “shedding.” Because the mRNA vaccines have been in development by the US Department of Defense DARPA since 2011, one would have expected that all of the necessary preclinical testing would have been completed before Operation Warp Speed was announced.
The 2015 FDA guidance on Gene Product Shedding Studies with gene therapies, which are defined as “all products that exert their effects by transcription and/or translation of transferred genetic material and/or by integration into the host genome and that are administered in the form of nucleic acids, viruses or genetically modified microorganisms”.[i] By this statement mRNA vaccines are indeed gene therapy products and should have been submitted to these excretion studies by DARPA funded researchers long ago.[ii] Sadly, these careful development steps were skipped from the beginning in our military-style vaccine development program, and now th...
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