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
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author Zariffa, Névine
Russek-Cohen, Estelle
author_facet Zariffa, Névine
Russek-Cohen, Estelle
author_sort Zariffa, Névine
collection PubMed
description 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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spelling pubmed-80611542021-04-23 Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches Zariffa, Névine Russek-Cohen, Estelle Ther Innov Regul Sci Commentary 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. Springer International Publishing 2021-04-22 2021 /pmc/articles/PMC8061154/ /pubmed/33886112 http://dx.doi.org/10.1007/s43441-021-00290-z Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Commentary
Zariffa, Névine
Russek-Cohen, Estelle
Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches
title Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches
title_full Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches
title_fullStr Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches
title_full_unstemmed Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches
title_short Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches
title_sort vaccines after an emergency use authorization (eua): modern evidence generation approaches
topic Commentary
url 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
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