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研究生:曾培琪
研究生(外文):Pei-Chi Tseng
論文名稱:緊急授權適用緊急標準? ——以美國COVID-19期間疫苗緊急授權為例
論文名稱(外文):Emergency Standards for Emergency Use? -US Vaccine EUAs during the COVID-19 Pandemic
指導教授:葉俊榮葉俊榮引用關係
指導教授(外文):Jiunn-Rong Yeh
口試委員:張文貞雷文玫
口試委員(外文):Wen-Chen ChangWen-May Rei
口試日期:2023-06-20
學位類別:碩士
校院名稱:國立臺灣大學
系所名稱:法律學系
學門:法律學門
學類:一般法律學類
論文種類:學術論文
論文出版年:2023
畢業學年度:111
論文頁數:187
中文關鍵詞:緊急授權科學證據審酌疫苗上市審查藥物上市審查COVID-19疫苗
外文關鍵詞:emergency use authorizationevaluation of scientific evidencevaccine approvaldrug approvalCOVID-19 vaccine
DOI:10.6342/NTU202302527
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本文研究主題為美國緊急授權制度下審查COVID-19疫苗的「緊急標準」,分析在緊急狀態下,美國是否採取了相較於平常時期更低的標準審酌科學證據。為了解美國食品藥物管理署(下稱食藥署)在不同情形下採擇科學證據的標準,本文首先檢視新藥審查中採用的多種加速機制,並以兩個具指標性的新藥:新型口服抗凝血劑以及C肝藥物作為分析個案,發現經歷過去二十年的修法以及資源投注,美國食藥署流暢、有系統地運用彈性的試驗設計、解讀試驗結果。相較之下,疫苗的發展與審查涉及較為複雜的試驗設計與執行考量,並且需要更為謹慎地處理安全性審查。Agriflu以及Flublok兩支流感疫苗分別使用已知技術與新技術研發,二者的上市審查則呈現美國食藥署雖然高度仰賴指引文件設定的標準,但也並非毫無彈性。最後,在COVID-19疫情的緊急狀態之下,美國食藥署運用指引以及高密度的對話溝通平順地作成了兼顧公共衛生目的的緊急授權決策。與美國相較,台灣食藥署對本土疫苗的審查受到地緣政治特性、欠缺大規模疫情以及資訊揭露不足等多重因素的影響。綜觀美國食藥署藥物、疫苗上市審查的軌跡,其在COVID-19疫情下所為的科學證據評價,立基於其過往多年累積的審查架構但不失彈性,同時也仍維持一定程度的資訊揭露,在政治性決策與科學證據採擇間取得平衡。
This thesis aims to understand what constituted the “emergency standards” for the COVID-19 vaccine under US Emergency Use Authorizations (EUAs), in particular whether the standards for evaluating scientific evidence were lowered compared to that under normal conditions. To gain a basic understanding of US Food and Drug Administration (FDA) assessment of scientific evidence under different circumstances, this thesis begins with an examination of expedited pathways for new drug approvals, using dabigatran and sofosbuvir, two landmark new drugs to demonstrate approval metrics. With updated legislation and increased resources in the past two decades, the US FDA is able to apply flexible standards for trial design and allow extrapolations of trial data in an organized and streamlined fashion. However, vaccine development and approval involved more complex trial design and implementation considerations, as well as greater attention to safety issues. The approval of two influenza seasonal vaccines Agriflu and Flublok, the former utilizing a well-known technique and the latter a novel technique, showed that the US FDA relied heavily on guidance documents for standard setting but were still subject to uncertainty. Finally, in the COVID-19 public health emergency, the US FDA utilized guidance documents and intense communication to conduct a smooth review process that reflected the political considerations during the pandemic. In comparison, Taiwan FDA’s approval of domestic vaccines was complicated by local concerns, including geopolitical issues, lack of infections and transparency. This thesis concludes that the evaluation of scientific evidence in US COVID-19 vaccine EUAs references the past, maintains resilience, and demonstrates adequate transparency, reflecting its political nature.
Table of Contents
中文摘要 ii
Abstract iii
Table of Contents v
CHAPTER 1 INTRODUCTION 1
I. FOREWORD 1
II. SHAPING THE QUESTION: WHAT ARE EMERGENCY STANDARDS FOR VACCINE EUAS? 4
III. LITERATURE REVIEW 8
A. US FDA Drug and Vaccine Approval Decision Making 8
B. Legal, Historical, and Technical Aspects of the EUA Program 11
IV. THEORIES AND METHODS 14
A. Building the Analytical Method 14
B. Research Materials and Scope 15
V. THESIS STRUCTURE 16
CHAPTER 2 GEARING UP FOR PRIORITY: REVIEW OF EVIDENCE IN NEW DRUGS 18
I. OVERVIEW OF THE FDA DRUG AND BIOLOGICS APPROVAL PROCEDURE 18
A. History of Acceleration: Law and Regulations 19
B. Evidence Considered in Acceleration Programs 24
C. Clinical Trial Requirements: Well-Controlled and Adequate? 29
II. RISK AND BENEFIT ANALYSIS UNDER PRIORITY: THE FIRST NOAC APPROVAL 33
A. Introduction of a New Hope or New Risks? 33
B. Trial Design: Challenging the Double-Blind Gold Standard 35
C. Was Superiority Important? 37
D. Unavailable Safer Options: Antidotes and Testing 40
E. Safer or Faster? – A Privileged Determination 47
III. BREAKTHROUGH FOR HEPATITIS C TREATMENT: SOFOSBUVIR 49
A. Synchronized Dancing Partners: the FDA, the FDA, and the Big Pharma………... 50
B. Improved Acceleration: PDUFA V 54
C. Breakthrough and Acceleration through Adjustments and Extrapolation 60
D. Approval Concerns: Cost-Effectiveness? 62
IV. CONCLUSION 65
CHAPTER 3 GUARDING THE HEALTHY: REVIEWING VACCINES ON TIME 67
I. OVERVIEW OF FDA BIOLOGICS APPROVAL 67
A. Safe, Pure and Potent 68
B. Accelerated Approvals for Vaccines 69
C. Special Regulations on Vaccine 71
II. LONG AND PROSPEROUS: INFLUENZA VACCINES 72
A. Decades Old But Always Refreshing 72
B. General Guidance and Accelerated Approval 74
III. HOW FAST CAN WE GET? –ACCELERATED APPROVAL FOR INFLUENZA VACCINES 77
A. As Fast As You Can: Accelerated Efficacy With Predetermined Surrogate Marker Criteria 78
B. No Steps to Skip: Acceleration With Standard Safety Requirements…. 82
C. Postmarketing Actions: Establishing Clinical Efficacy 85
D. Vaccine Acceleration: Immunogenicity, 6-Month Safety Follow-up, Trial Site Monitoring 86
IV. EVALUATING INFLUENZA VACCINES USING NOVEL TECHNIQUES 88
A. Approaching a New Technology: Trial and Error 88
B. Bridging and Achieving: Clinical or Immunogenicity Efficacy Endpoints 91
C. Watching Carefully: Evaluating Safety of Novel Vaccines 97
D. Decision Making: VRBPAC 100
E. Novel Vaccine Approval: Planning Ahead, Matching Results, and Confirming Trends 103
V. CONCLUSION 105
CHAPTER 4 EMERGENCY OPERATIONS: EUAS FOR COVID-19 VACCINES 109
I. OVERVIEW OF EMERGENCY USE AUTHORIZATION 111
A. The Federal Regulations: Emergency Determination, Medical Product Types, and Efficacy Standards 112
B. FDA Guidance on EUAs: A Focus on Procedure, and Wide FDA Discretion on Standards 118
II. THE COVID-19 PANDEMIC: RACING BY ROLLING 121
A. Declaration of Health Emergency 122
B. COVID-19 Vaccine Guidance Documents: Trial Design, Efficacy Cutoffs, and Safety Requirements 123
C. Interim Analysis –An Additional Role? 130
III. COVID-19 VACCINE APPROVALS BY THE US FDA 134
A. Trial Designs: Reflecting the Unknown 135
B. Efficacy in Excellence 141
C. Safety in Short 145
D. Benefit/Risk Assessment and VRBPAC Meetings: Balancing the Stakes 150
E. Success With Surprise 154
IV. COVID-19 VACCINE APPROVALS BY THE TFDA 159
A. Vaccine Approval Regulations and Expedition Programs 159
B. The COVID-19 Vaccine Approvals 161
C. The Medigen Vaccine (MVC COVID-19 Vaccine) 162
D. Emergency Considerations with a Local Touch? 164
V. CONCLUSION 165
CHAPTER 5 CONCLUSION: THE REFERENCE, RESILIENCE, AND REVELATION OF EVIDENCE REVIEW UNDER EMERGENCY 168
REFERENCES 175
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