Chemical and Biological CB Defense Program

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• Chemical and Biological (CB) Defense Program
• Medical Requirements Review
• for the
• Armed Forces Epidemiological Board
• Mr. Rick Prouty
• Medical Integrator
• Joint Service Integration Group (JSIG)
• 21 May 2002

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Agenda

• Medical NBC Defense Requirements Organization
• Medical NBC Defense Requirements Development
• User Participation in Program Review
• Requirements Analysis
• Medical NBC Defense Requirements Review
• Future Requirements

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Medical Program Sub-Panel (MPSP)
MG KEVIN C. KILEY MPSP CHAIRMAN
MS. DILLON MPSP COORDINATOR
COL GOUGE U.S. ARMY PRINCIPAL

RADM (L) HUFSTADER U.S. MARINE CORPS PRINCIPAL
Brig Gen TAYLOR U.S. AIR FORCE PRINCIPAL
CAPT MUSASHE U.S. NAVY PRINCIPAL
LCDR GUZMAN U.S. NAVY ACTION OFFICER
Lt Col DIFADO U.S. AIR FORCE ACTION OFFICER
LTC FUDGE U.S. ARMY ACTION OFFICER
CDR CANEVA U.S. MARINE CORPS ACTION OFFICER
Voting Mbrs - Army, Navy, Air Force and Marines
Non-Voting Mbrs - JPO-BD, J4, USSOCOM, DTRA,
USACMLS, MRMC, USACHPPM, AMEDDCS, JNBCDB, JSMG,
MEDCOM, DATSD(CBM), ASD(HA), OTSG, ACC, DMRTI,
JRCAM, USANCA, NMRC, NEHC, BUMED, CANUKUS MCCT,
AFRRI,
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Medical NBC Defense Requirements Development

• MPSP JWG held in Nov 98 to assess requirements
• Service user, Training and Doctrine, and
  material developer participated
• Medical requirement documents (legacy) were
  single service (Army) w/other services indicating
  Joint Interest
• ORDs reviewed and strategy developed for
  Service approval staffing
• Post MS II ORDs remained single service
  w/service requirements s identified at MS III
• MS I ORDs reformatted and staffed to Services
  for Joint Potential Designation / requirements
• Future requirements proposed requirement leads
  identified staffed IAW JSIG SOP
• MPSP Principals approved strategy 14 May 99

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User Participation in Program Review

• Prior to MPSP, medical combat developer
  participated in MS review of several programs
  resulting in return to tech base (e.g. Cyanide
  Pretreatment, Q-fever)
• Jan/Sep 00 - MPSP representatives participated
  in a review of ORDs for MS III (e.g. Antidote
  Treatment, Nerve Agent Auto-injector, Skin
  Exposure Reduction Paste Against Chemical Warfare
  Agents)
• Sep 01 Medical user participation formally
  incorporated into the Med Chem/Bio Defense
  Research Program DTO process
• Nov 01 - MPSP representatives participated in
  DTO transition reviews (e.g. Common Diagnostic
  System, Active Topical Skin Protectant, Chemo
  prophylaxis for Chemical Warfare Agents, Advanced
  Anticonvulsant System)
• JSIG Medical Integrator continues to work with
  RAD IV / PEO-CBD to ensure user representation
  for future program reviews

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Requirement Analysis

• May 99 - MPSP Principals directed the AOs to
  draft medical NBC Defense Mission Needs Statement
  (MNS)
• Mar 01 - Plan to integrate medical NBC defense
  MNS into the Joint NBC Defense MNS put on hold
  pending MAA/MNA analysis
• May 01 - JSIG planned to assess medical
  capability requirements across all functional
  areas via an Operational Impact Assessment
• Nov 01 - Due to accelerated analysis schedule,
  JSIG decided to integrate medical assessment into
  each capability area analysis
• Present - Contamination Avoidance, Protection,
  FGA analysis including medical capabilities
  underway

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Medical NBC Defense Requirement Review

• Next Generation Anthrax Vaccine
• Smallpox Vaccine
• Clostridium Botulinum Toxin Medical Defense
  System
• Improved Plague Vaccine
• Tularemia Vaccine
• Venezuelan Equine Encephalitis
• Q-fever Vaccine
• Skin Exposure Reduction Paste Against Chemical
  Warfare Agents
• Joint Biological Agent Identification
  Diagnostic System

• Advanced Anticonvulsant System
• Antidote Treatment, Nerve Agent Auto-injector
• Chemo prophylaxis for Chemical Warfare Agents
• Active Topical Skin Protectant
• Joint Medical NBC Decision Support Tool
• Cyanide Pretreatment
• Nerve Agent Pretreatment Pyridostigmine

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Next Generation Anthrax Vaccine System (NGA)
System Description
System Performance
System will protect humans against disease caused
by anthrax delivered as a biological warfare
agent. The system includes patient, public, and
leader training and education materials and
metrics to support employment of the vaccine as a
standing readiness requirement or in response to
threat indications
 The Next-Generation Anthrax Vaccine will provide
protection against aerosol challenge by a
battlefield delivered dose of Bacillus anthracis
as defined in AmedP-8 Vol II, (Biological) T.
The vaccine will be licensed by the U.S. Food
and Drug Administration T.
Capabilities
ORD Status / Milestones
Efficacy Eighty percent (T) 95 (O) of
persons vaccinated will be protected from death,
incapacitation, or clinical anthrax due to an
inhaled battlefield aerosol dose of Bacillus
anthracis. For the purpose of this requirement,
incapacitation will consist of illness sufficient
to render a casualty unable to perform their
mission for a period of 24 hours
JPL 18
DTO CB.33 - Recombinant Protective Antigen
completed Jan 02
Draft ORD Army Requirements Lead - will be
staffed for service annexes in Mar 02 approval
expected 2QFY03
Protection Provide a protective immune response
within 45 days (T) 21 days (O) of receiving
initial vaccination . Additional doses may be
administered to meet duration requirements of
this ORD. Provide protection as above for a
period of 1 year (T) five years (O) from the
completion of a 2 (T) 1 (O) dose series
MS A - 4QFY02
MS B - 3QFY05
MS C - 3QFY07
AoA completed report due Mar 02
Shelf Life at least 2 (T) 5 (O) years
Staffed for JPD Apr 00
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Smallpox Vaccine
System Performance
Vaccine and vaccinia immune globulin is to
protect service members from smallpox. The
variola virus causes smallpox, an acute febrile
eruptive disease that in its most severe form
(variola major) has a mortality of 20 percent or
more. Vaccination of service members was
discontinued in 1990 due to dwindling stocks and
expired immune globulin. The new vaccine will be
developed in 2 blocks to counter a potential
biological warfare (BW) threat.
The smallpox vaccine will provide protection
against aerosol challenge by a battlefield
delivered dosage of naturally occurring and known
weaponized varieties of variola T. Vaccinia
immune globulin will be developed for high risk
population. Vaccine will not require
scarification in Blk 2 T. The vaccine will be
licensed by the U.S. Food and Drug Administration
T.
ORD Status / Milestones
JPL 19
Efficacy Blk 12 - Eighty percent (T) 95
(O) of persons vaccinated will be protected
from death, incapacitation, or clinical smallpox
due to an inhaled battlefield aerosol dose of
Variola major . For the purpose of this
requirement, incapacitation will consist of
illness sufficient to render a casualty unable to
perform their mission for a period of 24 hours.
Legacy ORD Army approved 30 Nov 95
MS I approved 16 Nov 99 - CARDS 1287
ORD redrafted in BLKs for MS II Nov 01 ready for
staffing, expected approval Nov 02
Protection Provide a protective immune response
within 30 days (T) 14 days (O) of receiving
initial vaccination . Additional doses may be
administered to meet duration requirements of
this ORD. Provide protection as above for a
period of Blk I - 1 year (T) 3 years (O) and
Blk II - 3 year (T) 5 years (O) after a single
dose
MS II/B (Blk 1) - 1QFY03
MS III/C (Blk 1) - 2QFY05
Shelf Life at least 2 (T) 5 (O) years
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Clostridium Botulinum Toxin Medical Defense
System (CBT-MDS)
System Description
System Performance
A medical defense system to protect all service
members (SM) from the toxins derived from
serotypes of the bacteria Clostridium botulinum,
including but not limited to serotypes A, B, E,
and F. This system could include vaccines and
other prophylactic (antisera) and therapeutic
medical countermeasures
Monovalent vaccines will protect against as many
of the serotypes of CBT, including but not
limited to A, B, E, and F as technologically
feasible (T). Multivalent protection against all
serotypes affecting humans (O). All vaccines and
treatments must be licensed by the U.S. Food and
Drug Administration
Capabilities
ORD Status / Milestones
Efficacy Serum from at least 80 ( T) 90 (O)
of vaccinated SMs will protect animals challenged
with a battlefield dose
JPL 20
Legacy ORD Army approved
Protection Vaccine protect at least 1 year
(T) 3 yrs from single dose (O) from the
completion of multidose administration. An
immune response sufficient to meet threshold
efficacy within 30 days 15-30 days (O) of the
initial vaccination. Therapeutic drug/antisera
should be effective against as many of the
serotypes of CBT affecting humans (i.e. A, B, E,
and F) as practicable (T) multiple serotypes
(O) and produce a clinical improvement in 80
of SMs treated regardless of current botulism
immune status. Antisera used as a prophylaxis
should reduce combat casualties from CBT
intoxication by 80 for 8 hrs (T) 90 for 24 hrs
(O)  
MS I approved 16 Nov 98 - CARDS 14021
MS II/B (A/B) - 1QFY04
MS III/C (A/B) - 3QFY09
JVAP requested IPT in near future to review
therapeutics
Shelf Life vaccines, drugs, antitoxins, and
chemical reagents will have a shelf life of at
least 2 (T) 5 (O) years
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Improved Plague Vaccine IPgV
System Description
System Performance
The Improved Plague Vaccine System protects
humans against disease caused by the bacterium
Yersinia pestis, commonly known as plague. It
will be approved for use to protect against
plague used as a biological warfare agent. Upon
P3I, the IPgV will also be approved for use to
protect against naturally-occurring or
flea-transmitted plague. The IPgV includes
patient, public, and leader training and
education materials and metrics to support
employment of the vaccine
The improved plague vaccine will provide
protection against aerosol challenge by of
Yersinia pestis delivered in a battlefield
delivered dosage as defined by Planning Guide for
the Estimation of NBC Battle Casualties A-MedP-8,
Vol II (Biological) (T) The vaccine will be
licensed by the U.S. Food and Drug Administration
T.
Capabilities
ORD Status / Milestones
JPL 22
Efficacy Eighty percent (T) 90 (O) of
persons vaccinated will be protected from death,
incapacitation, or clinical plague due to an
inhaled battlefield aerosol dose of Yersinia
pestis . For the purpose of this requirement,
incapacitation will consist of illness sufficient
to render a casualty unable to perform their
mission for a period of 24 hours
DTO CB.34 - Recombinant Plague Vaccine
expected to transition in FY02
Draft ORD (Feb 00) - Army Requirements Lead -
approval expected 4QFY03
Protection Provide a protective immune response
within 45 days (T) 21 days (O) of receiving
initial vaccination . Additional doses may be
administered to meet duration requirements of
this ORD. Provide protection as above for a
period of 1 year (T) five years (O) from the
completion of a 3 (T) 1 (O) dose series
MS I - 2QFY03
MS II/B - 1QFY05
MS III/C - 1QFY012
Staffed for JPD Feb 00
Shelf Life at least 2 (T) 5 (O) years
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Tularemia Vaccine
System Performance
System that protects humans against disease
caused by the bacterium Francisella tularensis,
commonly known as tularemia. The System includes
patient, public, and leader training and
education materials and metrics to support
employment of the vaccine as a standing readiness
requirement or in response to threat indications
The tularemia vaccine will provide protection
against aerosol challenge by a battlefield
delivered dosage of Francisella tularensis as
defined by Planning Guide for the Estimation of
NBC Battle Casualties A-MedP-8, Vol II
(Biological) (T) The vaccine will be licensed by
the U.S. Food and Drug Administration T.
ORD Status / Milestones
JPL 23
Efficacy Eighty percent (T) 90 (O) of
persons vaccinated will be protected from death,
incapacitation, or clinical tularemia due to an
inhaled battlefield aerosol dose of Francisella
tularensis. For the purpose of this requirement,
incapacitation will consist of illness sufficient
to render a casualty unable to perform their
mission for a period of 24 hours
Legacy ORD Army approved (JSOR 24 Mar 88)
MS I - 20 Oct 93 CARDS 1469 IPR Nov 99
returned to Phase I
Protection Provide a protective immune response
within 45 days (T) 30 days (O) of receiving
initial vaccination . Additional doses may be
administered to meet duration requirements of
this ORD. Provide protection as above for a
period of 1 year (T) five years (O) from the
completion of a 3 (T) 1 (O) dose series
MS II/B - 4QFY05
MS III/C - 2QFY09
Staffed for JPD Feb 00
Shelf Life at least 2 (T) 5 (O) years
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Venezuelan Equine Encephalitis (VEE)
System Performance
Improved multivalent vaccine medical defense
system to protect all service members from
infections derive from the VEE virus, a
mosquito-borne incapacitating viral disease
endemic to the Americas. VEE potentially could
be weaponized for dispersal as an aerosolized
biological warfare (BW) agent and endemic disease
An investigational live attenuated virus vaccine
(TC-83) for VEE is currently available but has
low efficacy and significant side effects. A
killed virus vaccine, identified as C-84, is
available to immunize individuals who do not
respond to TC-83 but multiple doses are
required. The vaccine will be licensed by the
U.S. Food and Drug Administration T.
ORD Status / Milestones
JPL 24
Efficacy This vaccine will provide protection
for a minimum of 1 year (T) 3 years (O) in at
least 80 percent (T) greater than 80 (O) of
those receiving immunization from the dose
required to produce incapacitation in 80 percent
of those exposed to a BW challenge delivered as a
reasonable approximation of average battlefield
conditions.
Legacy ORD Army approved
MS I approved 29 Jun 98 - CARDS 14016
Protection Provide a protective immune response
within 30 days (T) 14 days (O) of receiving
initial vaccination series (T) single dose (O).
MS II/B (A/B) - 2QFY07
MS III/C (A/B) - 4QFY10
Shelf Life at least 3 (T) 5 (O) years
EEE WEE returned to tech base as recommended by
FY01 TARA
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Q-Fever Vaccine
System Description
System Performance
A candidate vaccine, Q-Vax currently licensed
in Australia and manufactured by CSL, was
originally considered to be a quick and
affordable vaccine against the use of C. burnetii
as a BW weapon. Skin testing remains a
prerequisite to inoculating . Due to inadequate
safety and efficacy data to support licensure,
major facilities renovations required, and
serological and testing would be needed in
addition to skin testing to mitigate adverse
reaction to vaccine, advanced development was
terminated and the program was turned back to
tech base
Vaccine to protect Service members (SM) against Q
Fever, an acute febrile disease caused by a
bacterial agent Coxiella burnetii most commonly
infected humans through inhalation of
contaminated aerosol, but may be infected
trans-dermally by tick bite and orally by
ingestion of contaminated meat and dairy
products. A Q-fever infection acquired from BW
exposure is likely to be caused from a greater
infective dose and may result in a more
debilitating period of illness than typical of
endemic disease.
Capabilities
ORD Status / Milestones
JPL 29
Efficacy Eighty percent (T) gt80 (O) of
persons vaccinated will be protected from death,
incapacitation, or clinical tularemia due to an
inhaled battlefield aerosol dose of Coxiella
burnetii. For the purpose of this requirement,
incapacitation will consist of illness sufficient
to render a casualty unable to perform their
mission for a period of 24 hours
Legacy ORD Army approved
MS I approved 14 Nov 95 - CARDS 1280
Returned to tech base in Feb 01
Protection Provide a protective immune response
within 14 days (T) 7 days (O) of receiving
initial vaccination . Additional doses may be
administered to meet duration requirements of
this ORD. Provide protection as above for a
period of 1 year (T) 2 years (O) from the
completion of a first series (T) 1 (O) dose
MS II/B - 1QFY05
MS III/C - 3QFY09
Shelf Life at least 2 (T) gt3 (O) years
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Skin Exposure Reduction Paste Against Chemical
Warfare Agents (SERPACWA)
System Performance
SERPACWA will augment the mission oriented
protective posture (MOPP) gear. It may allow
reduced levels of MOPP gear to be worn during
periods of heightened threat of attack. It may
extend the period of protection offered by the
MOPP overgarment by protecting areas of the skin
likely to be contaminated with C/BWA as the
overgarment is gradually defeated by liquid
agent.
A skin protectant to reduce or prevent the toxic
effects resulting from percutaneous penetration
of chemical warfare agents or biological toxins.
There are no fielded pretreatment or therapeutic
drugs to counteract the effects of vesicants
(i.e. sulfur mustard and lewisite) and T-2
mycotoxin
SERPACWA, originally known as TSP, was
FDA-approved in Feb 00
ORD Status / Milestones
JPL 33
Efficacy When used with the MOPP the TSP will
reduce for at least 4 hours (T) 6 hours (O) in
at least 80 (T) 90 (O) of those protected,
the rate of penetration of vesicants (mustard and
Lewisite), nerve agents (VX and soman GD) and
T-2 mycotoxins into the skin (on areas protected
by TSP) to a rate below that estimated to produce
combat casualties
Legacy ORD Army approved
MS I approved 14 Nov 95 - CARDS 1281
MS II - Nov 96
Protection When tested for a variety of combat
scenarios by an accepted modeling technique, the
use of the SERPACWA will indicate a reduction of
C/BWA casualties (T) (80 (O) (modeled against
the population protected with MOPP but without
SERPACWA)
MS III - Nov 00
Initial production in 3QFY02 Training support
package draft in staffing
Shelf Life at least 3 (T) 5 (O) years
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Joint Biological Agent Identification Diagnostic
System (JBAIDS)
System Performance
Block I will consist of production of the
analytical device, device consumables, and
protocols for identification of 10 (T) 20 (O)
BW threat assessment agents and biological agents
of operational significance. Block II consists of
the production of a new capability to identify 5
(T) 8 (O) toxins. Block III consists of
supplementation or replacement of the Block I and
II devices by a fully integrated and automated
specimen processing and analysis capability for
confirmation of all Blk III (T) all ITF-6 Cat
A (O) biological threat agents and biological
agents of operational significance. FDA approval
required.
A reusable, portable, modifiable biological agent
identification and diagnostic system capable of
simultaneous reliable identification of multiple
biological agents of operational concern and
other pathogens of clinical significance. JBAIDS
will be configured to support reliable, fast, and
specific identification of biological agents from
a variety of clinical sources and preventive
medicine samples.
ORD Status / Milestones
Identification The JBAIDS will identify the
target biological agents within a clinical range
for each of the agents 1000 colony/plaque
forming units per mL T and 100 colony/plaque
forming units per mL O. with a detection
sensitivity equal to 90 for identification of
target agents at or greater than the specified
limit of detection concentration T and greater
than 90 sensitivity in clinically relevant
samples (1 picogram per mL of concentration) O.
 
JPL 36
DTO CB.26 - Common Diagnostic System
transitioned 14 Nov 01
Draft ORD USAF Requirements Lead ORD will be
staffed Mar 02 approval expected Nov 02
Sensitivity Equal to Blk III - 85 T (98
O) Blk III - equal to 90 T (98 O) for
identification of target agents at or greater
than the specified limit of detection
concentrations.
MS A (Blk I) - 14 Nov 01
MS B (Blk I) - 2QFY03
Specificity Equal to Blk III - 90 T (98
O) Blk III - equal to 95 T (98 O) for
identification of target agents at or greater
than the specified limit of detection
concentrations
MS C (Blk I) - 1QFY04
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Future Requirements

• Automated Casualty Decontamination System
  USAF Lead
• NBC Casualty Transport System USAF Lead
• Visible Casualty Chemical Contamination
  Identifier USAF Lead
• Radiation Exposure Assessment Capability USA
  Lead
• Radiation Defense System (T/P/D) USA Lead
• Cyanide Pretreatment System (drug and monitor)
  USA Lead
• Staphylococcal Enterotoxin Vaccine USA Lead
• Medical NBC Defense Doctrine/Training Analysis
  (funded for FY02)
• Post Exposure Chemo Prophylaxis/Therapeutics
  for BW Agents

Subject to validation by analysis
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Post Exposure Chemo Prophylaxis/Therapeutics for
Biological Warfare Agents

• Protection Requirements
• before any known exposure
• post exposure / pre-symptomatic
• at the onset of symptoms
• confirmation of BW agent exposure
• User Goal provide MAT DEV documentation to
• move therapeutic candidates from off-label use
  for treatment to on-label use for pre/post
  exposure prophylaxis (FDA approved)
• continue vaccine development (FDA approved)
• acquire FDA approval for IND vaccines

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Contact Information
Rick Prouty Battelle Medical Integrator Joint
Service Integration Group Email
proutyr_at_wood.army.mil Phone [phone]
ext 37772 DSN 676-7772 After 1 Jun 02
- Email proutyr_at_battelle.org Phone
[phone] No DSN