Making Emergency Use of Experimental Vaccines Safer

AMA J Ethics. 2020 Jan 1;22(1):E43-49. doi: 10.1001/amajethics.2020.43.

Abstract

Ethical and logistical challenges of deploying experimental vaccines in humanitarian emergencies are exacerbated by a paucity of safety and efficacy data. For outbreaks caused by pathogens with high mortality rates and few treatments, such as Ebola virus disease, not offering access to experimental vaccines with some evidence of efficacy can also be ethically suspect. This article recommends (1) gathering more preclinical data about experimental vaccines' safety and (2) improving research infrastructure to enable participation of a wide range of subjects in affected communities over long trial periods. Motivating these goals would facilitate clearer definitions of population vulnerability and risk acceptability.

MeSH terms

  • Altruism
  • Disease Outbreaks / ethics*
  • Drug Approval
  • Emergencies*
  • Health Services Accessibility / ethics*
  • Hemorrhagic Fever, Ebola / prevention & control*
  • Humans
  • Patient Safety*
  • Research Subjects
  • Risk
  • Vaccination / ethics*
  • Vaccines* / adverse effects
  • Vulnerable Populations

Substances

  • Vaccines