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Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research

While having access to safe and efficient vaccines is essential for eradicating the COVID-19 pandemic, gaining marketing authorisation is a critical step in enabling and speeding this process. On December 2, 2020, the United Kingdom became the first country to approve the first COVID-19 vaccine. Thi...

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Autores principales: Abbas, Nasir, Babar, Zaheer-Ud-Din
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8704081/
https://www.ncbi.nlm.nih.gov/pubmed/34952647
http://dx.doi.org/10.1186/s40545-021-00400-0
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author Abbas, Nasir
Babar, Zaheer-Ud-Din
author_facet Abbas, Nasir
Babar, Zaheer-Ud-Din
author_sort Abbas, Nasir
collection PubMed
description While having access to safe and efficient vaccines is essential for eradicating the COVID-19 pandemic, gaining marketing authorisation is a critical step in enabling and speeding this process. On December 2, 2020, the United Kingdom became the first country to approve the first COVID-19 vaccine. This commentary aims to provide a quick overview of the UK’s COVID-19 vaccine authorization process and compare it to that of the EU and the US. While the UK, EU, and US expedited the COVID-19 vaccine approval process, regulatory authorities did not appear to cut corners in their approval of the Pfizer COVID-19 vaccine, as evidenced by their decisions to switch emergency use authorization to full authorization in the US and to renew conditional/temporary use authorization in the EU and UK, respectively. There is an opportunity to conduct a thorough investigation into and comparison of the filed dossiers, as well as the robustness of the evaluation process for the approval of COVID-19 vaccines.
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spelling pubmed-87040812021-12-27 Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research Abbas, Nasir Babar, Zaheer-Ud-Din J Pharm Policy Pract Commentary While having access to safe and efficient vaccines is essential for eradicating the COVID-19 pandemic, gaining marketing authorisation is a critical step in enabling and speeding this process. On December 2, 2020, the United Kingdom became the first country to approve the first COVID-19 vaccine. This commentary aims to provide a quick overview of the UK’s COVID-19 vaccine authorization process and compare it to that of the EU and the US. While the UK, EU, and US expedited the COVID-19 vaccine approval process, regulatory authorities did not appear to cut corners in their approval of the Pfizer COVID-19 vaccine, as evidenced by their decisions to switch emergency use authorization to full authorization in the US and to renew conditional/temporary use authorization in the EU and UK, respectively. There is an opportunity to conduct a thorough investigation into and comparison of the filed dossiers, as well as the robustness of the evaluation process for the approval of COVID-19 vaccines. BioMed Central 2021-12-24 /pmc/articles/PMC8704081/ /pubmed/34952647 http://dx.doi.org/10.1186/s40545-021-00400-0 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/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Abbas, Nasir
Babar, Zaheer-Ud-Din
Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research
title Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research
title_full Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research
title_fullStr Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research
title_full_unstemmed Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research
title_short Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research
title_sort marketing authorization of covid-19 vaccines across uk, eu, and the us: fact-checking and the implications for future research
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8704081/
https://www.ncbi.nlm.nih.gov/pubmed/34952647
http://dx.doi.org/10.1186/s40545-021-00400-0
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