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.



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