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新冠疫苗的安慰剂对照试验——它们在伦理上是否仍然可行?

Placebo-controlled trials of Covid-19 vaccines - Are they still ethical?

机构信息

Institute for Philosophical Research, National Autonomous University of Mexico, Circuito Mario de la Cueva s/n Ciudad Universitaria, Coyoacán, Mexico City 04510 MEXICO.

出版信息

Indian J Med Ethics. 2021 Apr-Jun;VI(2):1-8. doi: 10.20529/IJME.2021.015.

DOI:10.20529/IJME.2021.015
PMID:33908358
Abstract

A World Health Organization (WHO) Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation recently recommended placebo-controlled trials (PCT) of Covid-19 vaccines. PCTs are ethically acceptable when there is no proven effective and safe treatment for a certain condition. However, there are already some vaccines that have been approved and which have high levels of efficacy and safety. Any new vaccine under development must be tested against the most effective vaccines available. PCTs go against the participants' best interests, by putting them in a position of disadvantage while taking part in a trial, compared with people who are not in the trial and who could get vaccinated. Particularly in high-income countries, many people are getting vaccinated. This means that, following a recent trend in clinical trials, PCTs would have to be conducted in low- and middle-income countries, where there a number of advantages for drug companies, but where fatality rates of Covid-19 are, in many cases, much higher. For this and other reasons having to do with equal rights, participants in control groups should be protected with the most effective vaccines available.

摘要

世界卫生组织(WHO)关于新冠肺炎疫苗评估下一步措施的临时专家小组最近建议开展新冠肺炎疫苗的安慰剂对照试验(PCT)。当针对某种病症没有经过证实的有效和安全的治疗方法时,PCT 是符合伦理的。然而,已经有一些疫苗获得了批准,且具有较高的疗效和安全性。任何正在开发的新疫苗都必须与现有的最有效疫苗进行对比测试。与没有参加试验但可以接种疫苗的人相比,参加试验的人处于不利地位,这违背了参与者的最大利益。特别是在高收入国家,许多人已经接种了疫苗。这意味着,按照临床试验的最近趋势,PCT 必须在中低收入国家进行,这对制药公司来说有许多优势,但在许多情况下,这些国家的新冠肺炎死亡率要高得多。出于这些原因以及与平等权利有关的其他原因,对照组的参与者应该用现有的最有效疫苗来加以保护。

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