Production delays for the 2009 H1N1 pandemic vaccine using the current egg-based production technology heightened interest in alternative technologies that could expand the supply or accelerate the availability of influenza vaccine. Within the federal government, the Department of Health and Human Services (HHS) and the Department of Defense (DOD) support the development of technologies that can be used in producing influenza vaccines. HHS’s Food and Drug Administration (FDA) reviews licensing applications for new vaccine, and the Department of State is the U.S. diplomatic liaison to the international entity that declares worldwide pandemics. GAO was asked to review federal activities for the development of alternative technologies used in producing influenza vaccine. This report examines (1) federal funding from fiscal year 2005 through March 2011 for alternative technologies and the status of manufacturers’ efforts, (2) challenges to development and licensure identified by stakeholders, and (3) how HHS is addressing those challenges. GAO reviewed HHS and DOD documents and funding data. GAO also interviewed stakeholders, including manufacturer representatives, industry associations, and other experts on challenges to development and licensure. GAO interviewed HHS officials on how they are addressing those challenges.
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Influenza Vaccine: Federal Investments in Alternative Technologies and Challenges to Development and Licensure
- February 3, 2012
- | Filed under North America, Report, and 2001-2025
Information Sharing and Collaboration: Applications to Integrated Biosurveillance – Workshop Summary
“After the September 11, 2001, terrorist attacks and subsequent anthrax mailings, the U.S. government prioritized a biosurveillance strategy aimed at detecting, monitoring, and characterizing national security health threats in human and animal populations, food, water, agriculture, and the environment. A variety of agencies share biosurveillance responsibilities, and efforts have been made to improve national biosurveillance through data exchanges and collaboration. However, gaps and challenges in biosurveillance efforts and integration of biosurveillance activities remain. September 8-9, 2011, the IOM held a workshop to explore the information-sharing and collaboration processes needed for the nation’s integrated biosurveillance strategy. This document summarizes the workshop.”
- November 30, 2011
- | Filed under North America, Featured, Report, and 2001-2025
Information Sharing and Collaboration: Applications to Integrated Biosurveillance: Workshop Summary
After the September 11, 2001, terrorist attacks and subsequent anthrax mailings, the U.S. government prioritized a biosurveillance strategy aimed at detecting, monitoring, and characterizing national security health threats in human and animal populations, food, water, agriculture, and the environment. However, gaps and challenges in biosurveillance efforts and integration of biosurveillance activities remain. September 8-9, 2011, the IOM held a workshop to explore the information-sharing and collaboration processes needed for the nation’s integrated biosurveillance strategy.
- February 8, 2012
- | Filed under North America and Report
International Disease Surveillance: United States Government Goals and Paths Forward
The Center for Biosecurity of UPMC, under contract to the Defense Threat Reduction Agency (DTRA) through The Tauri Group, undertook a project entitled “International Disease Surveillance: United States Government Goals and Paths Forward.” This project focused on overarching issues related to USG interests in improving international surveillance for infectious diseases. The project also sought to foster ongoing communication and collaboration among DTRA, other USG agencies, NGOs, academia, and other parties engaged in international disease surveillance. Although several USG agencies were consulted for this project, this review did not analyze specific agency roles or responsibilities.
- December 1, 2010
- | Filed under North America, Report, and 2001-2025
Innovation’s Darker Future: Biosecurity, Technologies of Mass Empowerment, and the Constitution
Biothreats alone are not the problem; the full problem is the broader category of threats they represent. Over the coming decades, we are likely to see other areas of technological development that put enormous power in the hands of individuals. The issue will not simply be managing the threat of biological terrorism or biosecurity more broadly. It will be defining a relationship between the state and individuals with respect to the use and development of such dramatically empowering new technologies that both permits the state to protect security and at once insists that it does so without becoming oppressive.
By Benjamin Wittes
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