Author: Zariffa, Névine; Russek-Cohen, Estelle
Title: Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches Cord-id: 60qfk5p3 Document date: 2021_4_22
ID: 60qfk5p3
Snippet: 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
Document: 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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