TY - JOUR
T1 - Marketing authorization of COVID-19 vaccines across UK, EU, and the US
T2 - fact-checking and the implications for future research
AU - Abbas, Nasir
AU - Babar, Zaheer-Ud-Din
N1 - Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/12/24
Y1 - 2021/12/24
N2 - 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.
AB - 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.
KW - Marketing authorization
KW - COVID-19 vaccine
KW - EU
KW - US
KW - UK
KW - COVID-19 vaccines
UR - http://www.scopus.com/inward/record.url?scp=85121754353&partnerID=8YFLogxK
U2 - 10.1186/s40545-021-00400-0
DO - 10.1186/s40545-021-00400-0
M3 - Comment/debate
C2 - 34952647
VL - 14
JO - Journal of Pharmaceutical Policy and Practice
JF - Journal of Pharmaceutical Policy and Practice
SN - 2052-3211
IS - 1
M1 - 110
ER -