Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada

被引：27

作者：

Lythgoe, Mark P. ^{[1
]}

Middleton, Paul ^{[2
]}

机构：

[1] Hammersmith Hosp, Imperial Coll London, Dept Surg & Canc, Du Cane Rd, London W12 OHS, England

[2] St Marys Hosp, Imperial Coll London, Dept Metab Digest & Reprod, London, England

来源：

JAMA NETWORK OPEN | 2021年 / 4卷 / 06期

关键词：

D O I：

10.1001/jamanetworkopen.2021.14531

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

This qualitative improvement study investigates COVID-19 vaccine approvals at 3 medicine regulatory agencies in the US, EU, and Canada, characterizing and contrasting regulatory review times, and analyzing the clinical evidence supporting authorization.

引用

页数：3

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[2] Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012 [J].

Downing, Nicholas S. ;

Aminawung, Jenerius A. ;

Shah, Nilay D. ;

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Ross, Joseph S. .

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[3]

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[4]

Government of Canada, VACC TREATM COVID 19

[5] Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration [J].

Puthumana, Jeremy ;

Egilman, Alexander C. ;

Zhang, Audrey D. ;

Schwartz, Jason L. ;

Ross, Joseph S. .

JAMA INTERNAL MEDICINE, 2021, 181 (04) :559-560

[6]

US Food and Drug Administration, 2020, DEV LIC VACC PREV CO

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