FDA Has Known About Vaccine Shedding for Years and Has Even Issued Guidance on How to Evaluate the Risk
In 2015 the US Food and Drug Administration (“FDA”) issued guidance on how to conduct shedding studies during the preclinical and clinical development of virus or bacteria-based gene therapy products. Shedding, as described by the FDA, is the excretion or release of a product from a vaccinated person’s body. The shed gene therapy product may be infectious and so raises safety concerns “related to the risk of transmission to untreated individuals.”
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