effectively with the massive problems created by rotavirus, malaria, dengue, tuberculosis, and reemerging organisms; and perhaps even cope with the threat of biological terrorism. Without changes in the economics of vaccine innovation, however, significant progress on these fronts cannot be expected.

A State of Crisis

Our nation—and the world—faces a serious crisis with respect to vaccine development, production, and deployment. Concern has increased over the inadequacy of vaccine research and development efforts, periodic shortages of existing vaccines, and the lack of vaccines to prevent diseases that affect persons in developing countries disproportionately. Yet, too little has been done to resolve these issues. The evolving threat of intentional biological attacks makes the need for focused attention and action even more critical.

The challenges associated with vaccine innovation, production, and deployment are many and complex. Solutions will require a novel, coordinated approach among government agencies, academia, and industry. Issues that must be examined and addressed in a more meaningful and systematic fashion include the identification of priorities for research, the determination of effective incentive strategies for developers and manufacturers, liability concerns, and streamlining of the regulatory process. Currently, the federal government is neither addressing all of these challenges at a sufficiently high level nor providing adequate resources. Leadership, empowerment, and accountability are urgently needed at the cabinet level to ensure a comprehensive, integrated vaccine strategy that will address the following critical elements:

The U.S. Secretary of Health and Human Services should ensure the formulation and implementation of a national vaccine strategy for protecting the U.S. population from endemic and emerging microbial threats. Only by focusing leadership, authority, and accountability at the cabinet level can the federal government meet its national responsibility for ensuring an innovative and adequately funded research base for existing and emerging infectious diseases and the development of an ample supply of routinely recommended vaccines. The U.S. Secretary of Health and Human Services should work closely with other relevant federal agencies (e.g., DOD, the Department of Homeland Security, VA), Congress, industry, academia, and the public health community to carry out this responsibility.

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