Abbas Nasir, Babar Zaheer-Ud-Din
Department of Pharmacy, University of Huddersfield, Huddersfield, HD1 3DH, UK.
J Pharm Policy Pract. 2021 Dec 24;14(1):110. doi: 10.1186/s40545-021-00400-0.
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.
虽然获得安全有效的疫苗对于根除新冠疫情至关重要，但获得上市许可却是推动和加速这一进程的关键一步。2020年12月2日，英国成为首个批准首款新冠疫苗的国家。本评论旨在快速概述英国的新冠疫苗授权流程，并将其与欧盟和美国的流程进行比较。虽然英国、欧盟和美国都加快了新冠疫苗的审批流程，但监管机构在批准辉瑞新冠疫苗时似乎并未偷工减料，美国将紧急使用授权转为全面授权，以及欧盟和英国分别延长有条件/临时使用授权的决定就证明了这一点。有机会对提交的档案以及新冠疫苗批准评估过程的稳健性进行全面调查和比较。
