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“极速行动”:对全球疫苗安全的影响

Operation Warp Speed: implications for global vaccine security.

出版信息

Lancet Glob Health. 2021 Jul;9(7):e1017-e1021. doi: 10.1016/S2214-109X(21)00140-6. Epub 2021 Mar 26.

Abstract

Several global efforts are underway to develop COVID-19 vaccines, and interim analyses from phase 3 clinical testing have been announced by nine organisations: Pfizer, the Gamaleya Research Institute of Epidemiology and Microbiology, Moderna, AstraZeneca, Sinopharm Group, Sinovac Biotech, Johnson & Johnson, Novavax, and CanSino Biologics. The US programme known as Operation Warp Speed provided US$18 billion in funding for development of vaccines that were intended for US populations. Depending on safety and efficacy, vaccines can become available through mechanisms for emergency use, expanded access with informed consent, or full licensure. An important question is: how will these Operation Warp Speed vaccines be used for COVID-19 prevention in global health settings? We address some key questions that arise in the transition from US to global vaccine prevention efforts and from ethical and logistical issues to those that are relevant to global vaccine security, justice, equity, and diplomacy.

摘要

目前正在进行多项全球努力来研发新冠疫苗,已有九个组织宣布了3期临床试验的中期分析结果,这些组织包括:辉瑞公司、俄罗斯流行病学和微生物学国家研究中心加马列亚研究所、莫德纳公司、阿斯利康公司、中国国药集团、科兴生物制品有限公司、强生公司、诺瓦瓦克斯医药公司和康希诺生物股份公司。美国的“曲速行动”计划提供了180亿美元资金用于研发供美国民众使用的疫苗。根据安全性和有效性,疫苗可通过紧急使用机制、在获得知情同意的情况下扩大使用范围或全面获批上市等方式提供。一个重要问题是:这些“曲速行动”疫苗将如何用于全球卫生环境下的新冠预防?我们探讨了从美国疫苗预防努力向全球疫苗预防努力过渡过程中出现的一些关键问题,以及从伦理和后勤问题到与全球疫苗安全、正义、公平和外交相关的问题。

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