Giving Full Measure to Countermeasures Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents (2004) / Chapter Skim
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Appendix A: Background: The Current Dod Medical Biowarfare Countermeasures Program
Appendix A: Background: The Current Dod Medical Biowarfare Countermeasures Program
Pages 103-116
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From page 103... ...
ORGANIZATION OF DOD MEDICAL BIOLOGICAL DEFENSE ACTIVITIES As described in part in Chapters 1 and 2, the organization of DoD's program for developing medical countermeasures against biological warfare agents reflects a 1993 congressional mandate (P.L.
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Responsibility for advanced development and acquisition of chemical and biological countermeasures is assigned to the Joint Program Executive Office for Chemical and Biological Defense Programs (JPEO-CBD)
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From page 105... ...
DOD POLICIES RELATED TO MEDICAL DEFENSE AGAINST BIOLOGICAL WARFARE Two directives establish DoD policies and requirements related to medical aspects of biological warfare defense. Directive 6205.3, "DoD Immunization Program for Biological Warfare Defense," specifies that personnel assigned or scheduled for deployment to a high-threat area should be immunized against validated biological warfare threat agents for which suitable vaccines are available (DoD, 1993)
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From page 106... ...
forces from biological warfare threat agents. I Employ IND medical countermeasures only when FDA-licensed products are unavailable and o There is a confirmed high risk to force health protection that ne cessitates consideration of IND product use; o Only after an in-depth review and approval by the Secretary of Defense of a request initiated by a Commander of a Combatant Command through the Chairman of the Joint Chiefs of Staff and in coordination with the ASD(HA)
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From page 107... ...
. MEDICAL BIODEFENSE COUNTERMEASURES Countermeasures Currently Available The few FDA-approved countermeasures available against potential biological threat agents identified by DoD in its unclassified lists or against CDC's Category A agents are listed in Table A-1.
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From page 108... ...
No licensed vaccines are available against botulism, plague, tularemia, or the viral hemorrhagic fevers, although vaccines against all of these diseases are under development. Table A-1 also notes the availability of drugs with approved indications for the treatment of disease resulting from several of the threat agents of concern to DoD and the nation.
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From page 109... ...
Epsilon toxin of Clostridium perfringens Food safety threats (e.g., Salmonella species, Escherichia coli O157:H7, Shigella) Glanders (Burkholderia mallei)
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From page 110... ...
110 to of for for route way use months, labeling 18 for licensed difficult under different is over use for study doses support doses administration, Additional Information Vaccine 6 logistically military CDC seek change of fewer equine) vaccine and Agents Use use toxoid immune for (human for Threat INDs Contingency BioThrax postexposure Botulinum Botulinum globulins None Biological Against Approved Therapeutics Doxycycline Ciprofloxacin Penicillin No Gentamicin Doxycycline Ciprofloxacin Available Vaccine [BioThrax]
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From page 111... ...
111 is events many use, for mortality, adverse than of vaccine vaccines Risk from including higher other vaccines globulin vaccine vaccine vaccine immune (postexposure) Pasteur inactivated dilution)
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From page 112... ...
Two Phase 1 trials on liquid product completed July 2003 Pivotal clinical trial on lyophilized product completed October 2000 Fast-track approval granted by FDA, final BLA submission anticipated 2004 Intravenous cidofovir Ongoing research at USAMRIID Oral therapeutic Ongoing research at antiviral drugs based on USAMRIID cidofovir, or on non-DNA polymerase target Anthrax Recombinant anthrax DVC Phase 1 trials (Bacillus anthracis) vaccine (rPA, derived begun October 2002; from (Escherichia coli)
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From page 113... ...
through FY 2003; funded by NIAID for Phase 1 trial Venezuelan equine Vaccine DVC: encephalitis IND submission anticipated by March 2004 Phase 1 trial start anticipated June 2004 Ricin toxin Recombinant ricin Ongoing research at vaccine USAMRIID Therapeutics for Ongoing research at exposure to ricin USAMRIID Continued
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From page 114... ...
USAMRIID Viral hemorrhagic Multiagent vaccine Ongoing research at fevers (filoviruses, capable of protecting USAMRIID including Ebola and against various Ebola Marburg) and Marburg viruses Antivirals Ongoing research at USAMRIID Immunotherapies for Ongoing research at filoviruses USAMRIID General Alternate vaccine Ongoing research at delivery methods USAMRIID (oral, respiratory, transdermal)
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From page 115... ...
1993. Department of Defense Directive: DoD Immunization Program for Biological Warfare Defense.
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From page 116... ...
2003. Medical Chemical Biological Defense Research Program.
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