Executive Summary

PROJECT RATIONALE AND ORGANIZATION

Tremendous strides have been made in public health, the control of infectious diseases, and preventive medicine during the past century. Nevertheless, infectious agents remain a substantial threat to the operational capacity of U.S. military forces for three distinct reasons: (1) recruits continue to train in groups under crowded conditions, increasing the risk of spread of infectious agents; (2)deployed warfighters, whether on combat or peacekeeping missions, continue to come into contact with pathogens with which they have no prior experience and, therefore, against which they have no immunity; and (3) warfighters, along with others, face an increasing risk of the intentional use of weaponized infectious agents.

To review the process by which the U.S. military acquires vaccines to protect its warfighters against natural infectious disease threats, the Institute of Medicine (IOM) of the National Academies convened an expert committee, the Committee on a Strategy for Minimizing the Impact of Naturally Occurring Infectious Diseases of Military Importance: Vaccine Issues in the U.S. Military, in April 2000 to advise the U.S. Army Medical Research and Materiel Command (USAMRMC). This report is the final product of that IOM committee.

The charge to the committee was as follows:

The committee will analyze available information, hold workshops and make specific recommendations on both technical and policy aspects regarding the Department of Defense vaccine strategy to combat infectious diseases. The issues include: (1) reviewing the problem of the naturally occurring infectious diseases threat to military operations; (2)defining and prioritizing the diseases of relevance to the U.S. military; (3) determining the status of vaccines available to protect military personnel; (4) examining the Military



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Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military Executive Summary PROJECT RATIONALE AND ORGANIZATION Tremendous strides have been made in public health, the control of infectious diseases, and preventive medicine during the past century. Nevertheless, infectious agents remain a substantial threat to the operational capacity of U.S. military forces for three distinct reasons: (1) recruits continue to train in groups under crowded conditions, increasing the risk of spread of infectious agents; (2)deployed warfighters, whether on combat or peacekeeping missions, continue to come into contact with pathogens with which they have no prior experience and, therefore, against which they have no immunity; and (3) warfighters, along with others, face an increasing risk of the intentional use of weaponized infectious agents. To review the process by which the U.S. military acquires vaccines to protect its warfighters against natural infectious disease threats, the Institute of Medicine (IOM) of the National Academies convened an expert committee, the Committee on a Strategy for Minimizing the Impact of Naturally Occurring Infectious Diseases of Military Importance: Vaccine Issues in the U.S. Military, in April 2000 to advise the U.S. Army Medical Research and Materiel Command (USAMRMC). This report is the final product of that IOM committee. The charge to the committee was as follows: The committee will analyze available information, hold workshops and make specific recommendations on both technical and policy aspects regarding the Department of Defense vaccine strategy to combat infectious diseases. The issues include: (1) reviewing the problem of the naturally occurring infectious diseases threat to military operations; (2)defining and prioritizing the diseases of relevance to the U.S. military; (3) determining the status of vaccines available to protect military personnel; (4) examining the Military

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Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military 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-

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Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military lishment and maintenance of effective manufacturing facilities and, ultimately, the procurement (purchase) and stockpiling of vaccines for use by DoD for force protection. This report contains four chapters. It begins with an historical overview of the influence of naturally occurring infectious diseases on U.S. military operations and the research that has been conducted in response to the threats posed by naturally occurring infectious diseases. Chapter 2 describes the role of USAMRMC in DoD—in particular its Research Area Directorate for Infectious Diseases that manages the Military Infectious Diseases Research Program (MIDRP)—in the acquisition of vaccines against infectious diseases; the chapter includes the committee’s understanding of how current priorities emerge and the organizational context within which MIDRP operates. Chapter 3 describes current naturally occurring infectious disease threats and available vaccine countermeasures. In Chapter 4, the committee presents its recommendations in the context of its view of the limitations imposed by the current structure within DoD for managing the acquisition of vaccines against infectious diseases. HISTORICAL OVERVIEW A large body of historical literature describes the importance of infectious diseases in deciding the results of military campaigns. Napoleon ceased his advance in the eastern Mediterranean when faced with a plague outbreak in Jaffa. Florence Nightingale achieved fame by addressing the fundamental hygiene problems that had caused the extraordinarily high rates of injury-related gas gangrene during the Crimean War. Up until World War II, deaths due to infectious diseases outnumbered those due to direct combat injuries (Gordon, 1958), and the potential remains for naturally occurring or intentionally disseminated infectious diseases to play a pivotal role in determining the outcomes of future conflicts. In addition, in recent years U.S. troops have frequently been deployed to geographic regions where there exist endemic infectious agents against which the U.S. military does not have immediately available suitable, safe, and effective vaccines or appropriate chemoprophylactic agents. Military strategists have recognized the threat to military operations from infectious diseases since the beginning of the science of microbiology. The study of epidemics in military populations and the research done by military epidemiologists and microbiologists have led to major advances in public health and a better understanding of many infectious disease agents and their mechanisms of transmission. Two examples are Sir Ronald Ross’s studies on the role of the Anopheles mosquito in the transmission of malaria and Walter Reed’s observations on the role of the Aedes aegypti mosquito as a vector for the spread of yellow fever.

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Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military Vaccines have served as a key mode of preventing infections among America’s military forces since General George Washington ordered the systematic variolation of the Continental Army to protect the nascent nation’s soldiers from smallpox. VACCINE MISSION AND PROCEDURES OF USAMRMC USAMRMC, a subordinate command of the U.S. Army Medical Command, is charged with solving medical problems and providing medical product solutions to the U.S. armed forces. Among these solutions are vaccines. USAMRMC’s primary goal is to protect and sustain the health of the warfighter. Its website states that it is responsible for medical research, product development, technology assessment and rapid prototyping, medical logistics management, health facility planning, and medical information management and technology. USAMRMC estimates its fiscal year 2002 infectious diseases research funding (both vaccine-related and other projects) at approximately $63 million, not including its congressionally mandated and separately funded HIV-related activities.1 With activities throughout the United States and overseas, USAMRMC works from its headquarters, six research laboratory commands, and six administrative commands or directorates. The Army assigns approximately 4,600 military and civilian personnel to these units. As part of its medical research and development charge, USAMRMC manages 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 weaponized infectious agents; DoD assigns that mission to the Joint Vaccine Acquisition Program. Despite its role in vaccine acquisition, USAMRMC is not formally involved in determining DoD policy for vaccine use. The Office of the Assistant Secretary of Defense for Health Affairs establishes and implements policies relating to the health care services to be offered to the members of the U.S. armed forces. The civilian expert members of the Armed Forces Epidemiological Board, a standing scientific advisory committee under the executive agency of the Army, serve as scientific advisers to DoD and address issues such as disease control, health maintenance, and disease prevention, including the use of vaccines. It is noteworthy that USAMRMC is but one of many players in the current process in DoD by which the earliest recognition of a military medical problem leads to the development and acquisition of a licensed vaccine that is available for use by military personnel. Proposals for the acquisition of new vaccine 1   Dollar estimates are shown in more detail in Table 2-1 of the full report.

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Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military products for use by military personnel must pass through a complex series of priority-setting and budgeting processes and through the hands of various USAMRMC managers, as well as numerous DoD stakeholders outside USAMRMC. Within USAMRMC, the Research Area Directorate for Infectious Diseases, through MIDRP, which involves all military services, coordinates the early stages of research and development; and the U.S. Army Medical Materiel Development Activity works on the advanced development of specific products. DoD’s research efforts are facilitated by a number of cooperative agreements that are used to secure relationships with vaccine manufacturers, academic institutions, other governments, and U.S. government agencies other than DoD. Within DoD, operations and maintenance funding for the purchase and maintenance of acquired medical products (including vaccines) is managed separately from the research and development funding for vaccine-related research and development. Vaccine products recommended for use for the protection of new recruits or for general use among all members of the armed services are procured with funds for medical care (Defense Health Care). The USAMRMC commanding general has no authority in this process. Some vaccines recommended for use in specific deployments do, however, fall within the nominal authority of the USAMRMC through the U.S. Army Medical Materiel Agency. DoD administers 17 different vaccines for the prevention of infectious diseases among military personnel. The vaccines are administered to military personnel, where appropriate, on the basis of military occupation, the location of the deployment, and mission requirements. DISCUSSION Protecting the health of military personnel is essential to national security. Vaccines are often the most cost-effective way to protect individuals from infectious diseases, but their value is easily overlooked both within the civilian public health sector and within the military. The committee believes that DoD must assign a much higher priority to vaccine acquisition than it does now. In sifting through the evidence and hearing from a considerable number of those who are directly involved with vaccine acquisition, the committee came to realize that the current DoD vaccine acquisition process does not take sufficient account of the fact that vaccines are complex systems and not simply commodities that can be specified, procured, and placed on the shelf for future use. Much care and forethought are required for the development and initial acquisition of vaccines. The need for attention does not end once vaccines are licensed and made available to the military. DoD must continuously monitor the status of licensed vaccines and needs to have the ability to modify vaccines, including manufacturing processes and the facilities in which vaccines are produced, as regulatory agencies seek changes in the light of new scientific knowledge or in an effort to ensure product safety. To do this efficiently, the committee

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Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military concluded that a single authority needs to oversee both the advanced development and the procurement of vaccines, among other parts of the process, lest a licensed product be lost from the armamentarium because of an inability to support further refinement and development of the vaccine. An example of DoD’s lack of attention to the systems aspects of a protective vaccine is the loss of the vaccines against adenovirus serotypes 4 and 7 and the increased rates of respiratory disease that occurred among basic trainees when the vaccines were no longer available. A consolidation of authority across the entire spectrum of vaccine acquisition activities would help to solve this problem, as laid out in the specific recommendations that follow. At the same time, the committee concluded that the current duplication of management structures—for acquisition of vaccines for protection against biological warfare and for those for protection from naturally occurring infectious diseases—makes little sense. This is because many pathogens that may be used for biological warfare also occur naturally, and because the scientific, technical, manufacturing, and stockpiling issues that both programs face are so very similar. After reviewing the available evidence, the committee concluded that DoD’s vaccine acquisition procedures, coupled with its complex annual budgeting process, significantly hamper its vaccine acquisition activities and thwart effective coordination with the vaccine industry. These limitations prevent DoD from developing important vaccines. They also cause instability in essential vaccine-related research programs and result in an inability to have available for immediate use those vaccines that are critical for the protection of military personnel. Such an inefficient acquisition process puts military readiness at risk. Some militarily important vaccines are not available, in whole or in part, because of poorly aligned acquisition processes and an inadequate commitment of financial resources rather than uncleared scientific or technological hurdles. DoD’s approach to vaccines originates with the best intentions, involves skilled individuals, millions (but not sufficient millions) of dollars in funding, and intricate planning. Still, the committee believes that limitations in the acquisition process make the path from basic research to the procurement and use of vaccines both inefficient financially and cumbersome, resulting in occasional failure (as in the case of the adenovirus type 4 and 7 vaccines) and unacceptable delays (in the case of the anthrax vaccine) in vaccine acquisition. This approach risks the success of military operations and the health of personnel, and potentially places national security in jeopardy. RECOMMENDATIONS The committee’s recommendations, presented in Box ES-1, cover four broad aspects of the acquisition process: organization, authority, and responsibility; program and budget; manufacturing; and regulatory status of special-use vaccines. Chapter 4 of the report discusses each recommendation and provides the avail-

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Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military BOX ES-1 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. 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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Protecting Our Forces: Improving Vaccine Acquisition and Availability in the U.S. Military able supporting evidence and a description of the committee’s reasoning that led to each recommendation. CONCLUSION Partly because of the past success of DoD research programs, the public and even DoD personnel outside of the medical sphere know little about the contributions of the military’s infectious disease programs or the threats that its products have ameliorated. By creating a single vaccine authority with a credible advisory board and with budgetary authority and responsibility extending across the broad continuum of the vaccine acquisition cycle, from setting priorities to stockpiling of licensed products, DoD would enhance not only the effectiveness but also the visibility of its vaccine program. The creation of such an authority would also improve the likelihood that the vaccine acquisition process would be provided with a budget that is sufficient to accomplish its mission. It is a mission of enormous importance. Immunization is often the most effective means of preventing infectious diseases, in either civilian or military populations, and whether caused by naturally encountered infectious agents or purposeful exposures related to bioterrorism or biological warfare. In summary, DoD’s vaccine acquisition program, despite its distinguished history, diffuses responsibility and is inadequately funded; therefore, it cannot produce the effort required to respond to a task that has been made more urgent by the continuing emergence of new natural infectious disease threats and growing recognition of the risks of bioterrorism and biological warfare. The committee urges DoD to work more aggressively with decision makers in the U.S. Congress and in the executive branch to recognize that infectious disease agents—whether they occur naturally or are weaponized as agents of biological warfare or terror—threaten military operations and, therefore and implicitly, the welfare of the nation. Decision makers must recognize (1) the past, imminent, and possible future successes of vaccines in minimizing those threats; (2) the strong track records and reputations of military research programs in developing vaccines used by the U.S. military as well as in civilian settings; (3) the contributions that DoD’s medical research efforts make to foreign policy and national security; (4) the threats to continued vaccine development and the ultimate availability of vaccines that are posed by organizational and fiscal limits; and, consequently, (5) the need for adequate, stable funding and strong management authority. Such changes would allow DoD to optimally advance and exploit the technology available for vaccine development, and to provide the best possible protection of the nation’s armed forces against infectious diseases.