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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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Autori principali: Courtney L. Finch, Christian Martinez, Elizabeth Leffel, Mario H. Skiadopoulos, Adam Hacker, Betty Mwesigwa, Diadié Maïga, Ian Mugisa, Grant Munkwase, Roxana Rustomjee
Natura: Artigo
Lingua:Inglês
Pubblicazione: MDPI AG 2022-02-01
Serie:Vaccines
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Accesso online:https://www.mdpi.com/2076-393X/10/3/368
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