Infectious Diseases Research Program (MIDRP), with particular emphasis on current disease priorities, vaccine product development, and the role of the MIDRP not only within the framework of the overall Military Acquisition model, but also among other Federal government infectious disease programs; (5) reviewing the roles, if any, that the MIDRP should play in the licensure, manufacture, and distribution of vaccines against diseases of military importance, in the context of current interrelationships within DoD and among other federal agencies, industry, and university research activities; and (6)developing recommendations for a comprehensive strategy and doctrine that MIDRP and DoD could adopt to best use their resources to contribute toward the goal of effective development, licensure, production, stockpiling, distribution, and use of vaccines against naturally occurring diseases of military importance. Other issues regarding vaccine strategies against infectious diseases are likely to be brought to the attention of the committee by the DoD.
Based on their pre-committee experience, committee members believed that DoD’s current administrative separation of acquisition processes for vaccines intended to protect against naturally occurring infectious diseases and acquisition of vaccines for defense against biological warfare is scientifically—and likely organizationally—unsound. The challenges of vaccine research and development are similar for both natural and weaponized sources of infectious agents. Moreover, some of the agents are the same and vaccines remain a preferred defense for both. Thus, although this report initially was intended to address only naturally occurring infectious disease threats, because vaccine policy concerns related to biodefense are inseparable from those dealing with naturally occurring disease threats, the committee has touched on issues pertaining to the acquisition of biodefense vaccines in this report when pertinent.
In addition, the committee has interpreted the charge’s reference to “defining and prioritizing the diseases of relevance to the U.S. military” as a request to address how DoD should approach the issue of prioritization, rather than a request for the committee to offer a list of specific threats, diseases, or needed vaccine products.
The IOM committee met six times. It held open sessions at its first five meetings, hearing presentations from military personnel, those familiar with the vaccine industry, and infectious disease and vaccine experts. The committee used those briefings, its review of background material, and its members’ past experiences and expertise in its deliberations.
The committee notes that various documents and individuals within government—including the Department of Defense (DoD)—and elsewhere use the term acquisition variably. For the purposes of its discussions, the committee defined acquisition as the process by which DoD ensures that appropriate vaccines are available for the protection of its forces. This process represents a continuum extending from the first recognition of need for a vaccine, through the setting of priorities, to the maintenance of a technology base. It includes internally conducted or externally contracted product-oriented research, advanced product development, and clinical studies leading to licensure. It also involves the estab-