Principles of Vaccine Licensure, Approval, and Recommendations for Use.
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DOI: 10.1016/j.mayocp.2019.11.002
Abstract: The licensure and recommendation processes for vaccines are complex. In the United States, vaccines are licensed for the civilian and military populations on the basis of review of Biologics License Applications submitted to the Food… read more here.
Keywords: advisory committee; committee; principles vaccine; licensure ... See more keywords
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
Bridging Animal and Human Data in Pursuit of Vaccine Licensure
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DOI: 10.3390/vaccines10091384
Abstract: The FDA Animal Rule was devised to facilitate approval of candidate vaccines and therapeutics using animal survival data when human efficacy studies are not practical or ethical. This regulatory pathway is critical for candidates against… read more here.
Keywords: animal rule; vaccine licensure; animal human; licensure ... See more keywords