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Vaccine Licensure in the Absence of Human Efficacy Data

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 regulatory approval, Ph...

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Detalles Bibliográficos
Autores principales: Finch, Courtney L., Martinez, Christian, Leffel, Elizabeth, Skiadopoulos, Mario H., Hacker, Adam, Mwesigwa, Betty, Maïga, Diadié, Mugisa, Ian, Munkwase, Grant, Rustomjee, Roxana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8954083/
https://www.ncbi.nlm.nih.gov/pubmed/35335000
http://dx.doi.org/10.3390/vaccines10030368

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