A presentation (in powerpoint format) detailing the plan is ...A

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: