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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Appendix F Recommendations of the IOM Report Protecting Our Forces1 COMMITTEE RECOMMENDATIONS Organization, Authority, and Responsibility The committee recommends that the Department of Defense: Combine all DoD vaccine acquisition responsibilities under a single DoD authority that includes the entire spectrum of responsibility—from potential threat definition through research and development, advanced product development, clinical trials, licensure, manufacture, procurement, and continued maintenance of manufacturing practice standards and regulatory compliance. Consolidate infrastructure, funding, and personnel for DoD acquisition programs for biodefense and naturally occurring infectious disease vaccines. Ensure that there is an effective, ongoing senior advisory group—one providing perspectives from both within and outside of DoD—to assess program priorities and accomplishments, to act as a proponent for vaccines and other infectious disease countermeasures, and to maintain active relationships with current science and technology leaders in academic, government, and corporate sectors. 1 IOM (Institute of Medicine). 2002. Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military. Washington, D.C.: The National Academies Press. P. 133.
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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Program and Budget The committee recommends that the Department of Defense: Provide budget resources commensurate with the task. Actively encourage the development, distribution, and use of a well-defined and validated research priority-setting mechanism, which could involve prioritized, weighted lists of infectious disease threats and formal scenario-planning exercises. To do so requires infectious diseases surveillance and the collection and synthesis of epidemiologic information. Include programming goals that ensure greater strength and continuity in the science and technology base across the full spectrum of infectious disease threats, including research related to the epidemiology of infectious diseases, the nature of protective immunity, and both early and advanced vaccine product development. Leverage DoD research efforts by building greater interactions and an effective formalized coordinating structure that links DoD research to vaccine development activities carried out by the Department of Health and Human Services and other public and private groups. Manufacturing The committee recommends that the Department of Defense: Work toward manufacturing arrangements that ensure consistent vaccine availability by addressing long-term commitment, predictable volumes and prices, indemnification, and intellectual property issues. These arrangements should include consideration of vaccine-specific, government partnerships with individual private manufacturers, a private manufacturer consortium, and government-owned, contractor-operated vaccine-production facilities. Regulatory Status of Special-Use Vaccines The committee recommends that the Department of Defense: Vigorously seek a new paradigm for the regulation of special-use vaccines that remain in Investigational New Drug status with the Food and Drug Administration without reasonable prospects of licensure under current rules, ensuring demonstration of the safety and efficacy of these products commensurate with their anticipated use.
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