While its quiet, does any one know the process for the approval of therapeutic vaccines?
I assume phase I is vaccinating patients who don't have the virus and then checking for safety and an immune response i.e. the production of antibodies.
Would Phase II involve dosing a small group of people with the virus to confirm that the vaccine does clear the virus? And then Phase III would involve scaling the group up to thousands of patients across different countries and ethnicity groups?
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