Protecting Our Forces Improving Vaccine Acquisition and Availability in the U.S. Military (2002) / Chapter Skim
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2 Resources, Responsibilities, and Dynamics in the Military's Vaccine Mission
2 Resources, Responsibilities, and Dynamics in the Military's Vaccine Mission
Pages 20-38
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Army as the lead agent for DoD infectious diseases research.) The steps leading to the availability of a vaccine that protects military personnel against an infectious disease include identification of a need, research, development, testing, production, evaluation, regulatory compliance, and procurement.
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: Medical research and development Logistics and acquisition · Information management/information technology · Advanced technologies · Congressional programs As part of its medical research and development charge, USAMRMC has the responsibility for managing research as well as product development related to, among other things, vaccines and therapeutic agents aimed at preventing and controlling naturally occurring infectious diseases that are perceived to threaten the operational effectiveness of the armed forces. However, USAMRMC does not manage the advanced development of vaccines against biological agents that may be weaponized; DoD assigns that mission to the Joint Vaccine Acquisition Program (JVAP)
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Army Medical Research Unit Europe · U.S. Army MedicalResearch Unit Kenya Infectious disease-related research activities are carried out within several of these laboratories, specifically, the Walter Reed Army Institute of Research (WRAIR)
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· RAD2: Combat Casualty Care Research Program · RAD3: Military Operational Medicine Research Program · RAD4: Medical Chemical and Biological Defense Program RAD 1 is the research directorate that manages MIDRP, which is charged with development of products to protect deployed warfighters against naturally occurring infectious diseases. MIDRP management (represented as Research Area Director for Infectious Diseases in Figure 2-2)
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Budget Activityb Vaccine Other Total 6.1 Basic research 2.8 6.5 9.3 6.2 Exploratory development 20.7 11.6 32.3 6.3 Advanced development 7.9 6.3 14.2 MIDRP funding total 31.4 24.4 55.8 6.4 Demonstration and validation 3.8 0.2 4.0 6.5 Engineering and manufacturing development 2.1 1.2 3.3 Advanced development funding total 5.9 1.4 7.3 aThe MIDRP director explained that figures given include relevant funding for the Science and Technology Evaluation Program and Science and Technology Objectives. WRAIR overhead is a large item that is distributed in proportion to the size of the two types of support.
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and U.S. Army Medical Materiel Center Europe · Health facilities planning: Health Facilities Planning Agency Three of the four major subordinate commands of USAMRMC play significant roles in the vaccine acquisition process: USAMMDA, USAMRAA, and USAMMA.
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Regarding materiel solutions for infectious diseases, FOCs allow, for instance, consideration of vaccines, drugs, immunotherapies, immunoprophylactic preparations, vector control products, and diagnostic tests. As part of its threat identification and prioritization duties, the Army Medical Department (AMEDD)
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Navy and air force units, such as the Naval Health Research Center's Center for Deployment Health Research and the Force Health Protection and Surveillance Branch at Brooks Air Force Base, collect international information relating to epidemiology, disease surveillance, and biological research. The DoD Global Emerging Infections Surveillance and Response System, for which the army is the lead agent, also contributes to global infectious disease surveillance and response efforts.
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Once MIDRP recommends a product for transition to advanced development, a USAMMDA product manager works with a research coordinator to collect information and prepare a development plan. The vaccine product is then presented to representatives of other DoD organizational elements involved in the acquisition and procurement of medical materiel for approval.
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Funding for advanced development of vaccines against infectious diseases is substantially less (approximately $7.3 million total in FY 2002) than funding for technology base research funding ($55.8 million total in FY 2002; see also Table 2-1~.
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Each service is responsible for procuring its own required vaccines in coordination with USAMMA, the designated lead agent for vaccine supply (AFEB, 1999~. Medical care facilities purchase vaccine products recommended for routine use for the protection of the health of the members of the armed forces (e.g., adenovirus vaccine)
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Despite its charge to oversee research related to infectious diseases, the MIDRP management office (RAD1) reports that it is neither involved in CRADA development or approval nor routinely informed of the terms of such arrangements.
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academic institutions Development of a live attenuated vaccine for the prevention of diarrhea caused by enterotoxigenic Escherichia cold (ETEC) Development of a subunit vaccine for the prevention of Campylobacter infection Development of World Wide Webdriven bioinformatic platform of DNA microarrays Platforms for rapid DNA microarray prototyping Development of a prototype multivalent oral vaccine for travelers Examples of projects include: · Research of candidate vaccines for the prevention of HIV infection and AIDS · Development of a cholera vaccine for military personnel · Research and development of vaccine products against ETEC · Malaria vaccine development · Shigella vaccine development SOURCE: Adapted from Hoke (2002)
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A dramatic increase in NIH funding for research on biological agents that may be weaponized, totaling $1.5 billion for the National Institute of Allergy and Infectious Diseases alone, is requested in the President's proposed FY 2003 budget (NIH, 2002a)
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The bulk of the field research funded through this grant is carried out at the Armed Forces Research Institute of Medical Sciences, a subsidiary of WRAIR, and at other institutions in Thailand. MIDRP also provides funding for these projects.
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