COVID-19 vaccine trial ethics once we have efficacious vaccines.
COVID-19 vaccine trial ethics once we have efficacious vaccines.
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DOI：
10.1126/science.abf5084
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发表时间：
2020-12-11
期刊：
影响因子：
56.9
通讯作者：
Taylor, Holly A.
中科院分区：
文献类型：
--
作者：
Wendler, David;Ochoa, Jorge;Millum, Joseph;Grady, Christine;Taylor, Holly A.
为新冠肺炎确定一种或多种安全有效疫苗的史无前例的努力包括180多种处于开发中的候选疫苗(1)，至少12种处于第三阶段试验(2)。在一种迄今治疗选择有限的疾病大流行中，测试如此多的候选疫苗提出了一个关键挑战：如果一种候选疫苗被判断为安全有效，研究人员应该怎么做？美国食品和药物管理局的指导意见指出，在新冠肺炎候选疫苗被判定为“安全有效”的情况下，可能有必要进行讨论，“以解决伦理争论，打破盲目，并向安慰剂接受者提供疫苗”(3)。我们在这里考虑了该指南提出的两个问题：第一，如果在安慰剂对照试验中发现候选疫苗是安全有效的，研究人员是否应该按设计继续该试验？其次，研究人员是否应该继续使用安慰剂对照试验来测试其他候选疫苗？考虑到辉瑞公司和莫德纳公司最近宣布他们的候选疫苗被发现在预防有症状的新冠肺炎方面有效(4，5)，这两个问题尤其及时。
The unprecedented effort to identify one or more safe and effective vaccines for COVID-19 includes more than 180 candidates in development (1), with at least 12 in phase 3 trials (2). The testing of so many vaccine candidates, in a pandemic of a disease for which there are to date limited treatment options, raises a critical challenge: What should researchers do if a vaccine candidate is judged to be safe and efficacious? Guidance from the U.S. Food and Drug Administration (FDA) states that in the event that a COVID-19 vaccine candidate is judged to be “safe and effective,” discussion may be necessary “to address ethical arguments to break the blind and offer vaccine to placebo recipients” (3). We consider here two questions raised by this guidance: First, if a vaccine candidate is found to be safe and efficacious in a placebo-controlled trial, should the researchers continue that trial as designed? Second, should researchers continue to test other vaccine candidates using placebo-controlled trials? These two questions are especially timely given recent announcements by Pfizer and Moderna that their vaccine candidates have been found to be efficacious in preventing symptomatic COVID-19 (4,5).
影响因子：
2.2
作者：
Millum J;Grady C
通讯作者：
Grady C