Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities

The first phase 3 coronavirus disease 2019 (COVID-19) vaccine trials began in July 2020. China, Britain, and the US have experimental vaccines ready to move into large-scale human testing. In the US, the Vaccine and Treatment Evaluation Units, HIV Prevention Trials Network, AIDS Clinical Trials Group, and HIV Vaccine Trials Network have merged resources into Operation Warp Speed, as each phase 3 trial is anticipated to enroll 30 000 participants. Recruitment for the first US trial involving the Moderna vaccine is targeting participants “at high risk of SARS-CoV-2 infection.” However, even though 39 of the 50 largest US outbreaks have occurred in correctional facilities and the case rate of SARS-CoV-2 infection in prisons (3521 per 100 000) has been 5.5 times higher than the general population, one key setting in which US investigators will not be recruiting participants for trials of COVID-19 vaccines are prisons and jails. This omission is an example of unintended consequences of well-intentioned policies