This 60-minute forum discusses the ethics of a randomized control Phase III trial of a COVID vaccine in which volunteers are directly exposed to the virus.

The proponents of such “challenge trials” think they will speed up the necessary research, resulting in vaccines being approved sooner.  The opponents (who at the moment include NIH) not only find that unethical (in the absence of “rescue” therapies for those who develop Covid-19 as a result of a “challenge”) but doubt that it will speed up approval.

Learning Objectives

At the close of this forum you should be able to:

1. Identify the objectives of “human challenge trials” of vaccines.
2. Compare the effectiveness, under different circumstances, of randomized controlled trials with and without intentional exposure of participants to the virus against which the vaccine is intended to protect. Explain the ethical arguments, pro and con, on the use of human challenge trials.

Speaker

Daniel Wikler, Ph.D. Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard University

Facilitator

Alex M. Capron, University Professor
Scott H. Bice Chair in Healthcare Law, Policy and Ethics Professor of Medicine
and Law