Sharing the Burden of Ebola Vaccine-Related Adverse Events

Abstract

On December 9, 2014, United States Secretary of Health and Human Services Sylvia
Burwell issued a declaration under the U.S. Public Readiness and Emergency Preparedness (PREP)
Act to provide immunity from legal claims related to manufacturing, testing, development,
distribution, and administration of three candidate Ebola vaccines.1 At an earlier meeting of major
stakeholders held at the World Health Organization (WHO), the management of legal liabilities
related to vaccines was an important subject of the global response to Ebola addressed by national
governments, the World Bank, and others.2 That discussion, however, has faded as the epidemic
has been brought under control even as clinical trials for vaccine candidates commence.3 This
Essay argues that planning for the management of adverse event costs associated with rapidly
developed vaccines is in fact a critical opportunity in public health emergency preparedness and
recommends six options available to governments of countries afflicted by outbreaks of infectious
disease, governments in countries where vaccines are likely to be developed, major global vaccine
manufacturers, and major third-party sponsors such as the Bill and Melinda Gates Foundation, the
Global Alliance for Vaccines and Immunization (GAVI Alliance), the World Bank, and WHO.