The National Institute of Allergy and Infectious Diseases (NIAID) today released the NIAID Counter-Bioterrorism Research Agenda for CDC Category A Agents, a document describing the Institute's accelerated research plan for the most threatening agents of bioterrorism. The agenda outlines the research NIAID will undertake to help protect civilian populations from diseases such as smallpox, anthrax and plague should they be unleashed intentionally by those who wish to do harm. The comprehensive plan includes short-, intermediate- and long-term research goals and describes specifically how bioterrorism countermeasures will be developed for each microbe. The document also contains a copy of the Strategic Plan for Counter-Bioterrorism Research of the NIAID, which provides a general overview of the Institute's broad plans for attacking the full range of potential bioterrorism pathogens.

"Research is a vital element of bioterrorism defense," says HHS Secretary Tommy G. Thompson. "The NIAID Counter-Bioterrorism Research Agenda describes the highest priorities of an accelerated program to expand research on bioterrorism agents and to quickly develop new diagnostics, drugs and vaccines to protect the public."

The Research Agenda was developed by NIAID scientists and reviewed by an outside panel of experts from academia, industry and government in early February. The plan focuses on the Category A diseases as described by the Centers for Disease Control and Prevention (CDC): anthrax, smallpox, plague, tularemia, viral hemorrhagic fevers and botulism. Those diseases cause high death rates or serious illness, are relatively easy to spread, could cause public panic or require special steps for public health preparedness. NIAID plans to develop research plans for CDC Category B and C agents in the near future.

As the National Institutes of Health's lead institute on immunology and infectious diseases research, NIAID has made many key contributions to bioterrorism research over the years. In fiscal year 2003, the President proposes a $1.2 billion increase in bioterrorism funding for NIAID. The government's renewed focus on bioterrorism research will enable NIAID to expand ongoing projects and to establish much-needed new initiatives to prepare for potential bioterrorism attacks. New programs will involve traditional grants with academic researchers and institutions plus new models for government-industry partnerships.

According to NIAID Director Anthony S. Fauci, M.D., the proposed increase in research funding will also pay big benefits to other research. "In recent years, we have witnessed several emerging and re-emerging infectious diseases that have presented us with many of the same challenges as bioterrorism, namely identifying changing threats and preparing for them to appear at any time," he says. "In addition, people lack immunity to emerging diseases, and effective treatments are not always known. The influx of resources and renewed energy into infectious diseases research will no doubt help us enormously in tackling naturally occurring illnesses such as drug-resistant tuberculosis and influenza." Dr. Fauci also describes how increased basic research in immunology, including studies of the body's broadly protective innate immune system, should lead to additional advances in many non-infectious diseases such as cancer and autoimmune diseases.

The Research Agenda describes two separate but necessary arms of biomedical research. Basic research will continue to provide the framework for scientific and medical advances, and applied research will move laboratory developments into products that can be used to protect the public from disease. The agenda divides research on each Category A microbe into six key elements:

• Microbial biology. Increased basic research will help scientists acquire comprehensive information on the biology and disease-causing mechanisms of potential bioterror pathogens. Such information, which includes sequencing of each microbe's genome, will provide the information needed to develop new drugs and vaccines to combat possible bioterrorism-caused diseases.

• Human immune response. Increased research on the basic components of the human immune system will enable scientists to develop safe and potent vaccines, highly accurate diagnostic tests, and broadly acting drugs that boost overall immunity to a range of pathogens.

• Vaccines. Vaccines are one of the most effective ways to protect people from infectious diseases, and accelerated research on new vaccines is underway. New Ebola and anthrax vaccines will soon enter human testing, and research on improved smallpox and tularemia vaccines is ongoing. Additional research has been conducted on ways to stretch current smallpox vaccine stockpiles for the short term.

• Treatments. The increase in antibiotic resistance among bacteria and the relative scarcity of effective antiviral drugs make treatment research imperative. Scientists will use information gained from basic studies of a microbe's biology and genetic makeup to develop compounds that specifically destroy that organism or its toxins. Research on new treatments for pathogens such as smallpox and anthrax are currently underway.

• Diagnostics. An effective response against a bioterrorist attack requires rapid, accurate identification of both natural and bioengineered microbes. Information on a pathogen's sensitivity to available drugs will also help doctors quickly treat anyone who has become infected. New early warning and diagnostic tests are a key part of NIAID's bioterrorism research agenda.

• Research resources. Research on the five general areas above requires a broad range of resources including genomic information, novel reagents, animal models of disease, and high-containment laboratories and clinical facilities. NIAID will provide those resources in part by building the necessary facilities, establishing collaborations with industry, and training new scientists with varying expertise.

Many goals presented in the Research Agenda build on the results of ongoing NIAID research. New smallpox, Ebola and anthrax vaccines have been developed by NIAID researchers or grantees and are now approaching clinical testing. One of the first drugs to help treat smallpox was recently submitted to the FDA for approval, and two recent studies identified important biochemical features of two different anthrax toxins that have provided promising leads for new anthrax drugs. Over the past several years, NIAID scientists and grantees have made tremendous strides in understanding the complex physiology of the bacteria that cause anthrax and plague, for example. The mechanism of pathogenesis of Ebola virus and other agents is also better understood. In addition, rapid progress in determining the genetic blueprints of dangerous pathogens has provided a wealth of information on the underlying biology of those organisms.

The NIAID Counter-Bioterrorism Research Agenda for CDC Category A Agents is available online at http://www.niaid.nih.gov/dmid/pdf/biotresearchagenda.pdf. Researchers can find information on bioterrorism-related research funding opportunities at http://www.niaid.nih.gov/dmid/bioterrorism.

NIAID is a component of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institute of Allergy and Infectious Diseases is a component of the National Institutes of Health, U.S. Department of Health and Human Services.