Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches

Every medical product requires additional study even after regulatory approval. We highlight several lines of enquiry to advance our understanding of COVID19 vaccines post authorization: identifying key population segments warranting more study, assessment of efficacy, and of safety data, harmonizat...

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Detalles Bibliográficos
Autores principales: Zariffa, Névine, Russek-Cohen, Estelle
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061154/
https://www.ncbi.nlm.nih.gov/pubmed/33886112
http://dx.doi.org/10.1007/s43441-021-00290-z
Descripción
Sumario:Every medical product requires additional study even after regulatory approval. We highlight several lines of enquiry to advance our understanding of COVID19 vaccines post authorization: identifying key population segments warranting more study, assessment of efficacy, and of safety data, harmonization of data relating to immune response and developing mechanisms for data and knowledge sharing across countries. We show how innovative trial designs and sources from real world data play a critical role in generating evidence.

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