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Vanderbilt and Biodefense Research
February 26, 2003February 26, 2003
An Opportunity and a ResponsibilityAn Opportunity and a Responsibility
Objectives
• To discuss initiatives and opportunities in biodefense To discuss initiatives and opportunities in biodefense and emerging infections researchand emerging infections research
• To discuss Vanderbilt’s participation in a “Regional To discuss Vanderbilt’s participation in a “Regional Centers of Excellence in Biodefense” consortiumCenters of Excellence in Biodefense” consortium
• To describe Vanderbilt strengths in research with To describe Vanderbilt strengths in research with potential application to biodefense initiativespotential application to biodefense initiatives
• To identify additional programs with possible To identify additional programs with possible applicability to biodefense researchapplicability 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 ABacillus anthracis (anthrax)
Clostridium botulinum
Yersinia pestis
Variola major (smallpox) and other poxviruses
Francisella tularensis (tularemia)
Viral hemorrhagic fevers
Arenaviruses LCM, Junin virus, Machup virus, Guanarito virus Lassa Fever
Bunyaviruses Hantaviruses Rift Valley Fever
Flaviruses Dengue
Filoviruses Ebola Marburg
Category B Brucellosis Brucellosis ((BrucellaBrucella species)--Lab & Health Professionals species)--Lab & Health Professionals
Epsilon toxin of Epsilon toxin of Clostridium perfringensClostridium perfringens Food safety threats Food safety threats ( ( SalmonellaSalmonella species, species, Escherichia coliEscherichia coli O157:H7, O157:H7,
ShigellaShigella))
Glanders Glanders
Melioidosis Melioidosis
Psittacosis Psittacosis
Q fever Q fever
Ricin toxin from Ricin toxin from Ricinus communisRicinus communis (castor beans) (castor beans)
Staphylococcal enterotoxin BStaphylococcal enterotoxin B
Typhus fever Typhus fever Viral encephalitisViral encephalitis (Venezuelan equine encephalitis, eastern equine (Venezuelan equine encephalitis, eastern equine
encephalitis, western equine encephalitis)encephalitis, western equine encephalitis)
Water safety threats Water safety threats ((CholeraCholera, , CryptosporidiumCryptosporidium))
Category C
Emerging infectious disease threats such as Nipah virus and Emerging infectious disease threats such as Nipah virus and additional hantaviruses.additional hantaviruses.
NIAID priority areas:NIAID priority areas:
Tickborne hemorrhagic fever virusesTickborne hemorrhagic fever viruses Crimean-Congo Hemorrhagic fever virusCrimean-Congo Hemorrhagic fever virus Tickborne encephalitis virusesTickborne encephalitis viruses Yellow feverYellow fever Multi-drug resistant TBMulti-drug resistant TB InfluenzaInfluenza Other RickettsiasOther Rickettsias RabiesRabies
Key Events & Responses199
6-9
7
Select Agent Program Established Vanderbilt is registered as a Select Agent facility in December 2000.
Key Events & Responses199
6-9
7
9/1
1/0
1
Select Agent Program Established
WTC & Pentagon Attacks
9/11 emergency response included 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 & Responses199
6-9
7
9/1
1/0
1
Oct
‘01
Select Agent Program Established
WTC & Pentagon Attacks
Anthrax Letters
Vanderbilt EH&S and VUPD responded to >75 suspicious powders, packages, and mail. [4 responses last week!]
Conducted several training sessions regarding opening mail, etc.
Anthrax Incidence in HAS District (1988-2002)
18
12
23
18
7
46
43111
3
76
0
20
40
60
80
100
1988 1990 1992 1994 1996 1998 2000 2002
Inci
den
ce p
er 1
mil
lio
n p
op
ula
tio
n
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
CLINICAL MANIFESTATIONS
Complications of Cutaneous Anthrax Infection
Necrosis requiring
debridement
Persistentsecondary
infection
Death
No complications
78%
11%
3%8%
Key Events & Responses199
6-9
7
9/1
1/0
1
10/2
6/0
1
Oct
‘01
Fall
‘01
Late
‘01
Select Agent Program Established
WTC & Pentagon Attacks
Anthrax Letters
USA PATRIOT Act
UConn incident
HHS Inspector General visits begin
Vanderbilt establishes Lab Security & Accountability Task Group - comprised of faculty, research administrators, security, EH&S, legal counsel, Human Resources, and other stakeholders.
Key Events & Responses199
6-9
7
9/1
1/0
1
10/2
6/0
1
Oct
‘01
Fall
‘01
Late
‘01
Select Agent Program Established
WTC & Pentagon Attacks
Anthrax Letters
USA PATRIOT Act
UConn incident
Vanderbilt administration rejected proposal to work with anthrax based potential com-munity concerns.
IBC had previously voted approval and established a safety plan.HHS Inspector
General visits begin
Key Events & Responses6/1
2/0
2
Public Health Security. . .Act Lab Security & Accountability Task Group identifies method by which to obtain CDC/USDA notification from faculty.
Key Events & Responses6/1
2/0
2
9/1
0/0
2
Public Health Security. . .Act
CDC/USDA Notifications due
Deans request electronic (via 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 & Responses6/1
2/0
2
9/1
0/0
2
12/1
3/0
2Public Health Security. . .Act
CDC/USDA Notifications due
CDC/APHIS rules
IBC overseeing development of plans required under the new regulations.
Key Events & Responses6/1
2/0
2
9/1
0/0
2
12/1
3/0
2Public Health Security. . .Act
CDC/USDA Notifications due
CDC/APHIS rules
Acknowledgement that national security administrators are very interested and involved in how Select Agents are handled in our institutions.
1/1
5/0
3
Texas Tech incident
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.
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 forassuring safety and security on the institution and investigators.
Summary: