对COVID-19疫苗人体挑战研究的伦理挑战

Ethical Challenges to Human Challenge Studies for a COVID-19 Vaccine

2019冠状病毒病(COVID-19)大流行,巨大的感染人数和死亡人数的持续增加,使全球公共卫生面临严重的危机.安全有效的疫苗是遏制病毒蔓延的最有效的手段之一,人类对其需求迫在眉睫.采用标准的临床试验方式研发疫苗通常是一个漫长的过程,在目前紧迫的情况下,一些研究者开始提出用人体挑战试验这种可以大幅缩短疫苗研发时间的方式来代替传统漫长的III期临床试验.人体挑战研究涉及故意使健康受试者感染SARS-CoV-2毒株,以测试试验疫苗,这在国际社会引起了巨大的伦理争论.本文从包括受试者的受益与风险评估问题、可接受的风险程度问题以及有效批准治疗药物三个问题出发,对采用人体挑战研究开展COVID-19疫苗试验中的伦理挑战进行了分析.无论各国疫情流行情况如何,来自政治、社会、经济的巨大压力,以及对有效疫苗需求的紧迫性,都不应该影响我们对人体挑战试验进行科学、客观、理性的评估和伦理学判断.

The COVID-19 pandemic has posed a serious global public health crisis,with huge number of infections and deaths,and is still ascending.A safe and effective vaccine is one of the most important tools to contain the spread of the virus and is urgently needed.Standard clinical trials to develop vaccines is usually time consuming.Some researchers start to propose to utilize the human challenge studies as an alternative to the traditional phase III clinical trials since the human challenge studies can dramatically accelerate the vaccine testing.However,the human challenge studies involve deliberated infection of healthy volunteers with SARS-CoV-2 strain.It has brought huge concerns and caused worldwide ethical debates.In this paper,from three perspectives of benefit and risk assessment,acceptable extent of risk,and an approved treatment,we discussed the ethical challenges for human challenge studies of COVID-19 vaccine testing.However,the huge political,social and economic pressures and the urgency of the need for effective vaccines should affect neither the scientific evaluation nor the ethical judgments to human challenge studies of COVID-19 vaccine testing.