Ethical considerations for epidemic vaccine trials
Ethical considerations for epidemic vaccine trials
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DOI：
10.1136/medethics-2020-106235
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发表时间：
2020-07-01
影响因子：
4.1
通讯作者：
Monrad, Joshua Teperowski
中科院分区：
文献类型：
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作者：
Monrad, Joshua Teperowski
疫苗是保护个人健康和抗击 COVID-19 大流行等疫情的有力措施。当一种针对流行病的有效疫苗已成功开发出来，而研究人员试图在涉及人体的临床试验中测试另一种疫苗对相同病原体的功效时，就会出现伦理困境。一方面，有令人信服的理由说明，当有效产品已经存在时，尝试一种新型疫苗是不道德的。首先，医学道德的一项坚定原则是，如果患者的生命可能依赖于有效的治疗或疫苗，则不应拒绝向患者提供有效的治疗或疫苗。其次，由于流行病爆发经常发生在卫生系统资源匮乏的环境中，因此存在明显的风险，即任何拒绝有效疫苗的试验都会对历史上被用于生物医学研究的弱势群体产生不成比例的影响。第三，新型疫苗的临床试验可能与控制活跃疫情的努力不一致。另一方面，如果预期候选疫苗与现有产品相比具有某些优势，则可能有理由对候选疫苗进行试验。本文讨论了比较流行病原体疫苗的关键因素，包括免疫学、后勤和经济方面的考虑。除了埃博拉疫苗开发的案例研究外，本文还试图建立一个总体框架，该框架应由免疫学家、流行病学家、经济学家和生物伦理学家进行扩展和填充，并最终可应用于 COVID-19 疫苗的案例。
Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines.