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

Journal of Pharmaceutical Policy and Practice

Zaheer-Ud-Din Babar¹  Nasir Abbas¹ 

[1] Department of Pharmacy, University of Huddersfield, HD1 3DH, Huddersfield, UK;

关键词: Marketing authorization;    COVID-19 vaccines;    EU;    US;    UK;   

DOI  :  10.1186/s40545-021-00400-0

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY