Department of Public Health, Institute of Tropical Medicine, Antwerp, BELGIUM.
Indian J Med Ethics. 2021 Apr-Jun;VI(2):1-7. doi: 10.20529/IJME.2021.014.
Thanks to an impressive R&D effort, three vaccines for Covid-19 have been conditionally approved by stringent regulators as of February 2021, and sixteen have entered the WHO evaluation process. However, they all need to keep on being evaluated in clinical trials. The WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine suggested that countries with limited or no access to an effective vaccine could ethically permit placebo-controlled trials, even if effective vaccines were already being marketed elsewhere. Here, I argue that inclusion in a placebo-controlled trial is ethically sound for those who would be in any case ineligible for vaccination outside the trial, and as long as the access to the vaccine outside the trial depends on a transparent and just allocation framework. Conversely, carrying out placebo-controlled studies in countries where vaccines are not (or are insufficiently) available because of unequal global allocation, would be unethical, as an ethical strategy cannot be built on an unethical premise.
由于令人印象深刻的研发努力,截至 2021 年 2 月,有三种新冠肺炎疫苗已经通过了严格监管机构的有条件批准,还有 16 种疫苗已经进入了世界卫生组织的评估过程。然而,它们都需要在临床试验中继续进行评估。世界卫生组织新冠肺炎疫苗下一步行动临时专家组建议,对于那些获得有效疫苗的机会有限或没有机会获得有效疫苗的国家,可以在道德上允许进行安慰剂对照试验,即使有效疫苗已经在其他地方上市。在这里,我认为对于那些无论如何都不符合试验外接种条件的人来说,参加安慰剂对照试验在伦理上是合理的,只要试验外获得疫苗的途径取决于透明和公正的分配框架。相反,在由于不平等的全球分配而疫苗供应不足或无法供应的国家开展安慰剂对照研究是不道德的,因为伦理策略不能建立在不道德的前提下。