Assessment of risks associated with SARS-CoV-2 experimental human infection studies

Kuiper, Vincent P; Rosendaal, Frits R; Kamerling, Ingrid M C; Visser, Leonardus G; Roestenberg, Meta

Controlled human infection (CHI) models for the novel coronavirus (SARS-CoV-2) have been proposed as a tool to accelerate the development of vaccines and drugs. Such models carry inherent risks. Participants may develop severe disease or complications after deliberate infection. Prolonged isolation may negatively impact their wellbeing. Through secondary infection of study personnel or participant household contacts, the experimental virus strain may cause a community outbreak. We identified risks associated with such a SARS-CoV-2 CHI model and assessed their likelihood and impact and propose strategies that mitigate these risks. In this report, we show that risks can be minimized with proper risk mitigation strategies; the residual risk however should be weighed carefully against the scientific and social values of such a CHI model.