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...
