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The NIAID supports a broad-based program of basic and applied research to prevent, diagnose, and treat infectious and immune-mediated diseases. Integral to this mission is the responsibility to conduct biomedical research aimed at addressing the constant threat of naturally occurring, newly emerging, and reemerging or resurging infectious diseases. The specific mandate of the NIAID in the post–September 11 national security effort is to support research that will ultimately lead to the development of medical countermeasures in the form of therapies, vaccines, and diagnostic tools to protect the country from deliberate attacks with biologic agents.1,2 This role is consistent with the NIAID's long-established mandate with regard to infectious diseases, including emerging diseases such as AIDS and the severe acute respiratory syndrome (SARS) and resurging infectious diseases such as malaria, West Nile virus, and tuberculosis.3 Although the factors that precipitate the appearance of emerging, resurging, and deliberately propagated infectious diseases are quite distinct, the development of countermeasures for all three may be addressed with very similar scientific approaches.
Many members of the research communities in microbiology, infectious diseases, and immunology responded to the events of 2001 by expressing their willingness to contribute their skills and insights to the evolving biodefense efforts. The NIAID harnessed this spirit through a series of blue-ribbon panel meetings that were designed to enlist the best and the brightest in the development of a research agenda and strategic plan for biodefense research. The outcome of these discussions and deliberations is found in the NIAID Strategic Plan for Biodefense Research and the more detailed research agendas for agents in CDC categories A, B, and C, which are those pathogens most likely to be used and to cause harm in a bioterrorist attack.4,5 These documents provide the framework for addressing the research and training needs posed by this challenge to national security.
These plans are living documents that are regularly updated as progress is made. In August 2003, a progress report for category A agents was published and made available online.4 As detailed in the report, 50 new and expanded initiatives have been implemented, and substantial scientific accomplishments have been achieved in a relatively short period. Specifically, important progress has been made in the development of new or improved vaccines against anthrax, smallpox, and Ebola virus; the capacity for testing drugs and vaccines in animals, particularly nonhuman primates, has been markedly expanded; promising new drugs for the treatment of smallpox are being pursued; the genomes of all category A agents have been sequenced; and our understanding of the basic properties of the agents that pose threats has improved markedly. Despite these accomplishments, we are only in the early stages of a long-term process.
Our biodefense research agenda consists of a variety of programs designed to balance basic, translational, and applied research, with the objective of developing new and improved vaccines, drugs, and diagnostic tests (see Table). These programs involve collaboration with the academic community, as well as with the biotechnology sector, large pharmaceutical companies, and government partners.
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The program for constructing biocontainment laboratories is essential to the success of the biodefense research agenda and includes funding for the design, construction, and certification of biosafety level 4 and biosafety level 3 facilities. The national laboratories will include capacity for research at biosafety levels 4, 3, and 2; facilities for the conduct of research in nonhuman primates and other animals; and facilities and resources for small-scale phase 1 clinical trials in humans. The regional laboratories will provide capacity for research at biosafety levels 3 and 2, as well as facilities for research in animals. The laboratories will provide additional infrastructure for the RCEs and other NIAID-funded biodefense research. They will also be available to assist public health efforts in the event of a bioterrorism emergency. These will be state-of-the-art facilities, designed and built to the highest standards of safety and security, where 21st century research can be conducted.4 Together with the RCEs, these laboratories will provide a network for linking basic science and discovery to the product-development pathway, creating the capacity to address important scientific problems in a safe and expeditious manner. The NIAID funded two national laboratories and nine regional laboratories in the fall of 2003.4
Successful research requires not only access to appropriate technology and facilities, but also a robust corps of talented and committed scientists. Training and other efforts to increase the number of investigators engaged in this effort are essential, and to this end, several training programs in biodefense research have been initiated or expanded.4
Although we all hope that events such as the anthrax attacks of 2001 will never occur again and that our efforts to prepare and protect ourselves will be successful, the challenge of bioterrorism will be with us indefinitely. It is difficult to assess the probability of future deliberate releases of microbes or their products, but the potential consequences of such attacks are enormous. Furthermore, we will certainly face naturally occurring emerging and resurging infectious diseases, and the potential for devastation associated with such diseases as pandemic influenza or SARS may surpass that associated with bioterrorism.3 The research agenda of the NIAID and the NIH is designed to prepare for and provide protection against both types of threats. Given the nature of these threats, it is imperative that we move ahead with the biodefense research agenda as rapidly as possible. To do otherwise would be extremely risky and, in many respects, unconscionable.
Source Information
From the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, Md.
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