Abstract

COVID-19 is a global health emergency for which vaccines are a key solution. A human challenge trial (HCT) is a way of studying vaccine efficacy where healthy volunteers are deliberately infected, in contrast to traditional phase III trials. Nearly 40 000 people worldwide have expressed willingness to participate in COVID-19 HCTs in hopes of accelerating vaccine development. This essay argues that HCTs may not only fail to deliver on this aim, but violate the bioethical principles of autonomy, beneficence, non-maleficence, and justice. For now, in the case of COVID-19, HCTs are inferior to tried-and-true phase III trials, which have already generated several vaccines at unprecedented speed.

Learning Points

1. COVID-19 is a global health emergency for which vaccines are a key solution.
2. The risks of human challenge trials for COVID-19 outweigh their benefits in terms of the bioethical principles of autonomy, beneficence, non-maleficence, and justice.
3. Since traditional phase III trials have generated COVID-19 vaccines at unprecedented speed, there is currently negligible role for human challenge trials for COVID-19.

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