赋予 COVID-19 候选疫苗紧急使用授权：对 COVID-19 疫苗试验的影响。
The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials.
机构信息
Howard College School of Law, University of Kwazulu-Natal, Durban, South Africa; Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
出版信息
Lancet Infect Dis. 2021 Apr;21(4):e103-e109. doi: 10.1016/S1473-3099(20)30923-3. Epub 2020 Dec 8.
Abstract
An efficacious COVID-19 vaccine is currently the world's leading research priority. Several nations have indicated that if there is a compelling case for use of a vaccine before it is licensed, they would be prepared to authorise its emergency use or conditional approval on public health grounds. As of Dec 1, 2020, several developers of leading COVID-19 candidate vaccines have indicated that they have applied, or intend to apply, for emergency authorisation for their vaccines. Should candidate vaccines attain emergency use designation and be programmatically deployed before their phase 3 trials conclude, such a strategy could have far reaching consequences for COVID-19 vaccine research and the effective control of the COVID-19 pandemic. These issues merit careful consideration.
摘要
目前，世界各国都将研发有效的 COVID-19 疫苗作为首要任务。一些国家表示，如果有充分的理由在疫苗获得许可之前使用，他们将准备根据公共卫生理由授权其紧急使用或有条件批准。截至 2020 年 12 月 1 日，几种领先的 COVID-19 候选疫苗的开发商表示，他们已经申请或打算申请其疫苗的紧急授权。如果候选疫苗在其 3 期临床试验结束之前获得紧急使用指定并在计划中部署，那么这种策略可能会对 COVID-19 疫苗研究和有效控制 COVID-19 大流行产生深远影响。这些问题值得认真考虑。
相似文献
1
The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials.赋予 COVID-19 候选疫苗紧急使用授权：对 COVID-19 疫苗试验的影响。
Lancet Infect Dis. 2021 Apr;21(4):e103-e109. doi: 10.1016/S1473-3099(20)30923-3. Epub 2020 Dec 8.
2
WHO approval of Chinese CoronaVac COVID vaccine will be crucial to curbing pandemic.世界卫生组织批准中国科兴新冠疫苗对遏制疫情至关重要。
Nature. 2021 Jun;594(7862):161-162. doi: 10.1038/d41586-021-01497-8.
3
Lessons From Bacille Calmette-Guérin for SARS-CoV-2 Vaccine Candidates.从卡介苗（BCG）看新冠病毒候选疫苗。
J Infect Dis. 2021 Feb 3;223(2):189-191. doi: 10.1093/infdis/jiaa637.
4
Immunogenicity and safety of SARS-CoV-2 vaccines in clinical trials.临床试验中 SARS-CoV-2 疫苗的免疫原性和安全性。
Front Biosci (Landmark Ed). 2021 Nov 30;26(11):1286-1304. doi: 10.52586/5024.
5
New vaccine production platforms used in developing SARS-CoV-2 vaccine candidates.用于开发 SARS-CoV-2 候选疫苗的新型疫苗生产平台。
Vaccine. 2021 Jan 8;39(2):197-201. doi: 10.1016/j.vaccine.2020.11.054. Epub 2020 Nov 24.
6
Considerations in boosting COVID-19 vaccine immune responses.增强新冠病毒疫苗免疫反应的考量因素。
Lancet. 2021 Oct 9;398(10308):1377-1380. doi: 10.1016/S0140-6736(21)02046-8. Epub 2021 Sep 14.
7
[COVID-19: Warp Speed vaccines].[新冠疫情：极速疫苗]
Med Sci (Paris). 2021 Aug-Sep;37(8-9):759-772. doi: 10.1051/medsci/2021094. Epub 2021 Jun 3.
8
Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities.正在进行和未来的 COVID-19 疫苗临床试验：挑战与机遇。
Lancet Infect Dis. 2021 Nov;21(11):e342-e347. doi: 10.1016/S1473-3099(21)00263-2. Epub 2021 May 18.
9
COVID-19 vaccines: ethical framework concerning human challenge studies.COVID-19 疫苗：人体挑战研究的伦理框架。
Daru. 2020 Dec;28(2):807-812. doi: 10.1007/s40199-020-00371-8. Epub 2020 Aug 27.
10
Why emergency COVID-vaccine approvals pose a dilemma for scientists.为何新冠疫苗的紧急批准给科学家们带来了两难困境。
Nature. 2020 Dec;588(7836):18-19. doi: 10.1038/d41586-020-03219-y.
引用本文的文献
1
Accelerating the approval of mpox vaccines based on lessons learnt from COVID-19 vaccines through the lens of regulatory science.基于监管科学视角，借鉴新冠疫苗的经验教训，加速猴痘疫苗的审批。
BMJ Glob Health. 2025 Aug 14;10(8):e018517. doi: 10.1136/bmjgh-2024-018517.
2
Mucosal Vaccination Against SARS-CoV-2 Using Human Probiotic Spores as an Adjuvant Induces Potent Systemic and Mucosal Immunity.使用人类益生菌孢子作为佐剂的针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的黏膜疫苗可诱导强大的全身和黏膜免疫。
Vaccines (Basel). 2025 Jul 21;13(7):772. doi: 10.3390/vaccines13070772.
3
Immunogenicity and Safety of ChAdOx1 nCoV-19 (AZD1222) as a Homologous Fourth-Dose Booster: A Substudy of the Phase 3 COV003 Trial in Brazil.ChAdOx1 nCoV-19（AZD1222）作为同源第四剂加强针的免疫原性和安全性：巴西3期COV003试验的一项子研究
Mayo Clin Proc Innov Qual Outcomes. 2025 Jul 11;9(4):100642. doi: 10.1016/j.mayocpiqo.2025.100642. eCollection 2025 Aug.
4
Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study.AZD1222（ChAdOx1 nCoV-19）的长期安全性和免疫原性：一项3期研究的2年随访
Vaccines (Basel). 2024 Aug 3;12(8):883. doi: 10.3390/vaccines12080883.
5
Prior infections and effectiveness of SARS-CoV-2 vaccine in test-negative studies: a systematic review and meta-analysis.SARS-CoV-2疫苗在检测阴性研究中的既往感染情况及有效性：一项系统评价和荟萃分析
Am J Epidemiol. 2024 Dec 2;193(12):1868-1881. doi: 10.1093/aje/kwae142.
6
Expediting approval for medical countermeasures to address high burden disease: an ethical justification to move beyond emergency use authorisation.加快审批医疗对策以应对高负担疾病：超越紧急使用授权的伦理理由。
BMJ Glob Health. 2023 Nov;8(11). doi: 10.1136/bmjgh-2023-013480.
7
"We are Tired but Do Not Give Up" the Dilemma and Challenges of Primary Nurses Facing the Omicron Variant: Qualitative Research.“我们疲惫但不放弃”：初级护士面对奥密克戎变异株的困境与挑战：定性研究
J Multidiscip Healthc. 2023 Mar 27;16:797-809. doi: 10.2147/JMDH.S404177. eCollection 2023.
8
Using a health belief model to assess COVID-19 vaccine intention and hesitancy in Jakarta, Indonesia.运用健康信念模型评估印度尼西亚雅加达居民对新冠疫苗的接种意愿及犹豫程度。
PLOS Glob Public Health. 2022 Oct 28;2(10):e0000934. doi: 10.1371/journal.pgph.0000934. eCollection 2022.
9
Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees.在 COVID-19 研究中遇到的关键伦理问题：南非研究伦理委员会观点的主题分析。
BMC Med Ethics. 2023 Feb 15;24(1):11. doi: 10.1186/s12910-023-00888-y.
10
Fast Methods for Drug Approval: Research Perspectives for Pandemic Preparedness.快速药物审批方法：大流行防范的研究视角。
Int J Environ Res Public Health. 2023 Jan 29;20(3):2404. doi: 10.3390/ijerph20032404.
本文引用的文献
1
Will covid-19 vaccines save lives? Current trials aren't designed to tell us.新冠疫苗能拯救生命吗？目前的试验并非旨在告诉我们这一点。
BMJ. 2020 Oct 21;371:m4037. doi: 10.1136/bmj.m4037.
2
Covid-19 vaccine trial protocols released.新冠疫苗试验方案已公布。
BMJ. 2020 Oct 21;371:m4058. doi: 10.1136/bmj.m4058.
3
COVID-19 vaccine trials: Duty of care and standard of prevention considerations.2019冠状病毒病疫苗试验：注意义务与预防标准考量
Vaccine. 2020 Nov 10;38(48):7578-7580. doi: 10.1016/j.vaccine.2020.10.012. Epub 2020 Oct 9.
4
Emergency Use Authorization of Covid Vaccines - Safety and Efficacy Follow-up Considerations.新冠疫苗的紧急使用授权——安全性和有效性随访考量
N Engl J Med. 2020 Nov 5;383(19):e107. doi: 10.1056/NEJMp2031373. Epub 2020 Oct 16.
5
The Russian vaccine for COVID-19.俄罗斯的新冠疫苗。
Lancet Respir Med. 2020 Nov;8(11):e85-e86. doi: 10.1016/S2213-2600(20)30402-1. Epub 2020 Sep 5.
6
Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency.公共卫生紧急状态下新冠疫苗的监管决策
JAMA. 2020 Oct 6;324(13):1284-1285. doi: 10.1001/jama.2020.17101.
7
The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies.迈向 COVID-19 群体免疫的漫长道路：疫苗平台技术和大规模免疫策略。
Front Immunol. 2020 Jul 21;11:1817. doi: 10.3389/fimmu.2020.01817. eCollection 2020.
8
Unwavering Regulatory Safeguards for COVID-19 Vaccines.对新冠疫苗坚定不移的监管保障措施。
JAMA. 2020 Sep 8;324(10):931-932. doi: 10.1001/jama.2020.15725.
9
COVID-19 therapeutics: how to sow confusion and break public trust during international public health emergencies.新冠病毒病（COVID-19）治疗方法：在国际突发公共卫生事件期间如何制造混乱并破坏公众信任。
J Pharm Policy Pract. 2020 Jul 24;13:47. doi: 10.1186/s40545-020-00244-0. eCollection 2020.
10
The role of immune correlates of protection on the pathway to licensure, policy decision and use of group B Streptococcus vaccines for maternal immunization: considerations from World Health Organization consultations.免疫保护相关因素在 B 型链球菌疫苗获得许可、政策决策和用于母亲免疫接种的路径中的作用：来自世界卫生组织磋商的考虑。
Vaccine. 2019 May 27;37(24):3190-3198. doi: 10.1016/j.vaccine.2019.04.039. Epub 2019 Apr 25.
Zotero 插件