Abstract

Human infection challenge studies involving the intentional infection of research participants with a disease-causing agent have recently been suggested as a means to speed up the search for a vaccine for the ongoing coronavirus disease 2019 (COVID-19) outbreak. Calls for challenge studies, however, rely on the expected social value of these studies. This value represents more than the simple possibility that a successful study will lead to the rapid development and dissemination of vaccines but also some expectation that this will actually occur. I show how this expectation may not be realistic in the current political moment and offer potential ways to make sure that any challenge trials that arise actually achieve their goals.

Highlights

  • Human infection challenge studies involving the intentional infection of research participants with a disease-causing agent have recently been suggested as a means to speed up the search for a vaccine for the ongoing coronavirus disease 2019 (COVID-19) outbreak

  • The ongoing coronavirus disease 2019 (COVID-19) outbreak has caused more than 10 million confirmed cases of illness and over 500,000 deaths worldwide

  • This is, or should be, uncontroversial: the ethical guidelines for challenge studies were established almost 20 years ago [4], and challenge studies have been conducted in justifiable ways with infectious diseases for longer [5,6,7]

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Summary

Introduction

Human infection challenge studies involving the intentional infection of research participants with a disease-causing agent have recently been suggested as a means to speed up the search for a vaccine for the ongoing coronavirus disease 2019 (COVID-19) outbreak. Countering such a pandemic, given its global scope and a history of political missteps in responding to the virus in its early stages, will arguably require a vaccine.

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