Vaccine Licensure in the Absence of Human Efficacy Data
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DOI: 10.3390/vaccines10030368
Abstract: Clinical vaccine development and regulatory approval generally occurs in a linear, sequential manner: Phase 1: safety, immunogenicity; Phase 2: immunogenicity, safety, dose ranging, and preliminary efficacy; Phase 3: definitive efficacy, safety, lot consistency; and following… read more here.
Keywords: safety; phase; vaccine licensure; licensure ... See more keywords