Global Bioheroes: clinical research and new vaccines for health security

Abstract

ABSTRACTIn the pursuit of ‘global health security’, some governments advocate deployment of pharmaceuticals to combat deadly infectious diseases wherever they emerge. Following the Ebola outbreak in West Africa, attention has turned to other emerging diseases and future pharmaceutical solutions. There is growing support for enabling faster clinical research to make new vaccines available sooner. Research on experimental vaccines must ordinarily be consistent with ethical principles designed to protect human research participants. However, where a target disease is framed in security terms, it could be argued that an extraordinary response is required: exposing research participants to more risk in order to accelerate research and enable more lives to be saved pharmaceutically. This article assesses two scenarios of security-oriented research. The scenario envisaged by the Coalition for Epidemic Preparedness Innovations (CEPI) is the propelling of vaccine research through to the stage of human safety-testing before a natural outbreak of the relevant disease. Efficacy and effectiveness tests are then able to be conducted once an outbreak begins. In a hypothetical second scenario, pre-outbreak vaccine research undertaken for the sake of health security would also include efficacy-testing. This would involve the exposure to pathogenic microorganisms of healthy volunteers (‘global bioheroes’) from around the world.