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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program (2006)

Chapter: Appendix F Recommendations of the IOM Report Protecting Our Forces

« Previous: Appendix E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)
Suggested Citation:"Appendix F Recommendations of the IOM Report Protecting Our Forces." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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Appendix F
Recommendations of the IOM Report Protecting Our Forces1

COMMITTEE RECOMMENDATIONS

Organization, Authority, and Responsibility

The committee recommends that the Department of Defense:

  1. 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.

  2. Consolidate infrastructure, funding, and personnel for DoD acquisition programs for biodefense and naturally occurring infectious disease vaccines.

  3. 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.

Suggested Citation:"Appendix F Recommendations of the IOM Report Protecting Our Forces." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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Program and Budget

The committee recommends that the Department of Defense:

  1. Provide budget resources commensurate with the task.

  2. 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.

  3. 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.

  4. 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:

  1. 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:

  1. 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.

Suggested Citation:"Appendix F Recommendations of the IOM Report Protecting Our Forces." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 105
Suggested Citation:"Appendix F Recommendations of the IOM Report Protecting Our Forces." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 106
Next: Appendix G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production »
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Malaria is an infectious disease common to several parts of the world, including Africa, northern South America, and Asia. During their service in the military, U.S. active members may be sent to any part of the world, including parts of the world where Malaria is an issue. In Liberia in 2003, for example, there was a 28 percent attack rate in Marines who spent a short time ashore, and half of the 80 Marines affected needed to be evacuated to Germany. This was not only costly to the U.S. military but dangerous as well. To fight against this disease, there exists a Malaria Vaccine program in the U.S. military. However, there exists a variety of potential vaccine targets for the most severe and important form of malaria; malaria from the species Plasmodium falciparum. Issues also arise with the fact that there are three possible stages to create vaccines against—preerythrocytic, blood, or transmission.

The Department of Defense (DoD), through the commanding general of the U.S. Army Medical Research and Materiel Command (USAMRMC), requested that the Institute of Medicine (IOM) conduct a programmatic review of the military Plasmodium falciparum malaria vaccine research and development program. There was to be a focus on vaccine against the preerythrocytic and blood stages. The IOM formed a committee of 11 experts with collective expertise in malaria vaccine research, parasite immunology, malarial biology, clinical trials and regulatory affairs, industrial and public-sector vaccine development, biologic products research and development (vaccinology), military research and development programs, tropical medicine, and public health.

The committee focused different tasks including determining whether the DoD malaria vaccine research and development program is scientifically sound and able to achieve the vaccine program objectives within specified timelines, recommending how to overcome significant, identified barriers, and identifying major strategic goals and timelines based on the material received and presentations made by the DoD's program representatives. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program presents the committee's findings, current malaria vaccines, and recommendations for the development of the U.S. Military vaccine research.

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