Author: William Wiebe

Human Challenge Trials—A Coronavirus Taboo

The idea is as simple as it is apparently repulsive: allow human challenge trials (HCTs) under which “low risk” and healthy young adult volunteers in double-blind studies would be given trial vaccines (or a placebo) and then intentionally exposed to the novel coronavirus. This would accelerate the assessment of the trial vaccine’s safety and efficacy and more generally expand our understanding of this virus in a controlled setting. According to the World Health Organization (WHO), more than 70 vaccines are currently under development, five of which are already moving to clinical trials. Notwithstanding these Herculean efforts, the earliest we can realistically expect a readily available vaccine is in 12 to 18 months. This is in large part due to constraints imposed by traditional vaccine validation methods, which rely on large test groups and chance exposure to the virus by participants to assess the vaccine’s safety and efficacy. HCTs, using a relatively small low-risk group of volunteer participants, could potentially accelerate the release of a safe and effective vaccine by many months. While conducting coronavirus HCTs …