The Ethics of Continuing Placebo in SARS-CoV-2 Vaccine Trials

Type Journal Article Author Annette Rid Author Marc Lipsitch Author Franklin G. Miller URL https://jamanetwork.com/journals/jama/fullarticle/2774382 Series Viewpoint Publication JAMA Network Date 14/12/2020 DOI doi:10.1001/jama.2020.25053 Abstract As the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic continues to rage, developing safe and effective vaccines is critically important. With unprecedented speed, multiple candidate vaccines are now being evaluated in placebo-controlled clinical trials that have enrolled hundreds of thousands of participants. According to Pfizer-BioNTech and Moderna, interim analyses after approximately 2 months of follow-up suggest their vaccines are 90% to 95% effective at preventing SARS-CoV-2 infection, although no peer review of the data has been conducted to date. Both companies now claim they have an “ethical obligation” to offer vaccine as soon as possible to all participants who received placebo, considering the strong results and participants’ contribution to the research.1,2 This Viewpoint argues that given limited vaccine supply for at least several months, only the participants receiving placebo who would be eligible for vaccination outside the trial should be offered access to the vaccines at this point. The argument is explored in the US context, setting aside ethical questions about global vaccine distribution. If the US Food and Drug Administration grants an Emergency Use Authorization for the vaccines, as appears likely at the time of writing, the supply of vaccines will initially be limited. Government officials project that at most 40 million doses will be available in December 2020.3 This amount would be sufficient to vaccinate 20 million people, a fraction of what would be needed to protect the population. Priorities for vaccination therefore need to be set.