Vanderbilt and Biodefense Research An Opportunity and a Responsibility February 26, 2003 Objectives • To discuss initiatives and opportunities in biodefense and emerging infections research • To discuss Vanderbilt’s participation in a “Regional Centers of Excellence in Biodefense” consortium • To describe Vanderbilt strengths in research with potential application to biodefense initiatives • To identify additional programs with possible applicability to biodefense research The National Institute of Allergy and Infectious Diseases (NIAID) supports and carries out biomedical research to understand, prevent, and treat infectious and immunologic human diseases. Infectious diseases include those caused by new, emerging and re-emerging infectious agents, including those infections that are intentionally introduced as an act of bioterrorism. The recent deliberate exposure of U.S. civilians to spores of the anthrax bacterium, Bacillus anthracis, uncovered an unmet need for tests to rapidly diagnose, vaccines and immunotherapies to prevent, and drugs and biologics to cure diseases caused by agents of bioterrorism. NIAID and other federal health agencies are evaluating and accelerating measures to protect the civilian population from the health consequences of such an attack. Category A Bacillus anthracis (anthrax) Arenaviruses Clostridium botulinum LCM, Junin virus, Machup virus, Guanarito virus Yersinia pestis Lassa Fever Variola major (smallpox) and Bunyaviruses other poxviruses Hantaviruses Francisella tularensis Rift Valley Fever (tularemia) Flaviruses Dengue Viral hemorrhagic fevers Filoviruses Ebola Marburg Category B Brucellosis (Brucella species)--Lab & Health Professionals Epsilon toxin of Clostridium perfringens Food safety threats ( Salmonella species, Escherichia coli O157:H7, Shigella) Glanders Melioidosis Psittacosis Q fever Ricin toxin from Ricinus communis (castor beans) Staphylococcal enterotoxin B Typhus fever Viral encephalitis (Venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis) Water safety threats (Cholera, Cryptosporidium) Category C Emerging infectious disease threats such as Nipah virus and additional hantaviruses. NIAID priority areas: Tickborne hemorrhagic fever viruses Crimean-Congo Hemorrhagic fever virus Tickborne encephalitis viruses Yellow fever Multi-drug resistant TB Influenza Other Rickettsias Rabies Key Events & Responses Select Agent Program Established Vanderbilt is registered as a Select Agent facility in December 2000. Key Events & Responses Select Agent Program Established 9/11 emergency response included WTC & Pentagon Attacks identifying labora- tories with Select Agents so that extra security could be provided. VEHS sent out memo requesting voluntary disclosure of possession of Select Agents. Key Events & Responses Select Agent Program Established Vanderbilt EH&S and VUPD WTC & Pentagon Attacks responded to >75 suspicious powders, Anthrax Letters packages, and mail. [4 responses last week!] Conducted several training sessions regarding opening mail, etc. Anthrax Incidence in HAS District (1988-2002) 100 Incidence per 1 million population 23 80 18 18 60 12 40 7 7 6 6 20 3 4 4 3 1 1 1 0 1988 1990 1992 1994 1996 1998 2000 2002 CLINICAL MANIFESTATIONS Presentation 90% present with edema (often massive) 20-30% febrile (80-90% complain of fevers) Other common complaints – tenderness, abdominal pain, headache Location of Lesion 70% Face and Neck (eyes and mouth) 15% Arms, 10% Trunk, 5% Legs Complications of Cutaneous Anthrax Infection Persistent Death secondary infection 8% 3% Necrosis requiring 11% debridement No complications 78% Key Events & Responses Select Agent Program Established Vanderbilt establishes Lab WTC & Pentagon Attacks Security & Accountability Task Anthrax Letters Group - comprised of faculty, research USA PATRIOT Act administrators, security, EH&S, UConn incident legal counsel, Human Resources, and other HHS Inspector stakeholders. General visits begin Key Events & Responses Select Agent Program Established Vanderbilt administration WTC & Pentagon Attacks rejected proposal to work with Anthrax Letters anthrax based potential com- USA PATRIOT Act munity concerns. UConn incident IBC had previously voted approval and established a HHS Inspector safety plan. General visits begin Key Events & Responses Public Health Security. . .Act Lab Security & Accountability Task Group identifies method by which to obtain CDC/USDA notification from faculty. Key Events & Responses Public Health Security. . .Act Deans request electronic (via CDC/USDA Notifications due BioWISE) disclosure of non-possession or possession from 700+ faculty members. Three previously undisclosed agents are found; seven investigators with no previous disclosure Key Events & Responses Public Health Security. . .Act IBC overseeing development of plans CDC/USDA Notifications due required under the new regulations. CDC/APHIS rules Key Events & Responses Public Health Security. . .Act Acknowledgement that national security CDC/USDA Notifications due administrators are very interested and CDC/APHIS rules involved in how Select Agents are Texas Tech incident handled in our institutions. The overall goal of the RCE Program is to develop and maintain strong infrastructure and multifaceted research and development activities that will provide the scientific information and translational research capacity to make the next generation of therapeutics, vaccines and diagnostics against the NIAID Category A, B, C agents, with particular emphasis on Category A RBL program will provide support for building and/or renovating biosafety level (BSL-3) facility and necessary associated BSL-2 laboratories, animal facilities, and research support space. Summary: We see biodefense as not only a national priority but also an exciting research agenda. Thus, there is a tremendous impetus and opportunity to conduct research with select agents. At the same time in working with select agents there is a substantial obligation imposed for assuring safety and security on the institution and investigators.