Coordinated strategy to accelerate development of vaccines for infectious diseases : report to Congress

Hyde United States Global Leadership against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, Public Law 110-293, is to strengthen and enhance U.S. leadership and the effectiveness of the U.S. response to the HIV/AIDS, tuberculosis, and malaria pandemics and other related and preventable infectious diseases as part of the overall U.S. health and development agenda. Section 206 of this law states the President shall produce a comprehensive report, written by a study group of qualified professionals from relevant Federal agencies and initiatives, nongovernmental organizations, and industry representatives, that sets forth a coordinated strategy to accelerate development of vaccines for infectious diseases, such as HIV/AIDS, malaria, and tuberculosis, which includes: (1) initiatives to create economic incentives for the research, development, and manufacturing of vaccines for HIV/AIDS, tuberculosis, malaria, and other infectious diseases; (2) an expansion of public-private partnerships and the leveraging of resources from other countries and the private sector; and (3) efforts to maximize United States capabilities to support clinical trials of vaccines in developing countries and to address the challenges of delivering vaccines in developing countries to minimize delays in access once vaccines are available. This comprehensive report responds to this request. This report was compiled and edited by the congressionally mandated study group, which was set up for this purpose. The group met face-to-face on August 12, 2009, and worked virtually in the preparation of this report between July 2009 and September 2009. The study group includes professionals from the U.S. Agency for International Development (USAID), the National Institutes for Health (NIH), the Centers for Disease Control and Prevention (CDC), the National Vaccine Program Office of the Department of Health and Human Services, the Department of Defense (DoD), the Department of Treasury, PATH, the International AIDS Vaccine Initiative, Aeras Global TB Vaccine Foundation, the Center for Global Development, the Bill & Melinda Gates Foundation (BMGF), and Merck & Co. Section II of this report includes background on vaccine development. Section III provides a summary overview of the U.S. strategy for malaria, HIV/AIDS, tuberculosis, and other infectious diseases. Section IV discusses initiatives to create economic incentives for the research and development (R&D) of vaccines. Section V discusses the role of public-private partnerships and the leveraging of resources from other countries. Section VI provides a summary of the role that the United States Government (USG) plays in supporting clinical trials in developing countries and also provides an overview of current efforts to overcome challenges associated with vaccine delivery. And, Section VII provides a summary of the future direction of the USG vaccine development strategy. (Author abstract, modified)