Protecting Our Forces Improving Vaccine Acquisition and Availability in the U.S. Military (2002) / Chapter Skim
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4 Recommendations with Accompanying Analysis of Limitations Imposed by Current Department of Defense Structure for Managing Acquisition of Vaccines Against Infectious Diseases
4 Recommendations with Accompanying Analysis of Limitations Imposed by Current Department of Defense Structure for Managing Acquisition of Vaccines Against Infectious Diseases
Pages 55-94
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From page 55... ...
DoD's longstanding interest in the use of vaccines to protect military personnel against infectious disease threats is reflected in this committee's charge as well as in DoD's separate request to an expert panel led by Franklin Top, Jr., (DoD, 2001 d) for advice on its vaccine production capability.
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From page 56... ...
Protecting the health of military personnel is essential to national security. The committee presented in Chapter 1 historic evidence that infectious diseases have posed significant threats to the health of the nation's armed forces.
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From page 57... ...
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 because of unmet scientific or technological hurdles. This is particularly true for the vaccines listed in Table 3-5, including, for example, the attenuated Junin virus (Argentine hemorrhagic fever)
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From page 59... ...
Figure 4-1 also vividly demonstrates the absence of a single organizational locus of authority and responsibility for that process. Not only is no individual in charge, but too many individuals and entities are responsible for other, unrelated activities in addition to their responsibilities for vaccines and the development of effective countermeasures against infectious disease threats.
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From page 61... ...
These committees are not the first to note organizational and procedural problems within the DoD's acquisition processes. The DoD Reorganization Act of 1986 called on DoD to "reduce and streamline the defense bureaucracy" (Republican Policy Committee, 1986~.
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From page 62... ...
. Having expended considerable time in attempting to understand the complexities of the current acquisition process, the committee concludes that DoD should create a single vaccine authority by concentrating responsibility and authority for the entire vaccine life cycle up to, but not including, policy and clinical decisions concerning the use of vaccines.
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From page 63... ...
To succeed, this vaccine authority must have the following: · sufficient authority to influence vaccine development, including adequate budgetary authority with assured funding for operations (such as for the procurement of vaccine products after the research period) and control over any governmentowned manufacturing facility, such as the government-owned, contractor-operated (GOCO)
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From page 64... ...
Combine all DoD vaccine acquisition responsibilities under a single authority within DoD that attends to the entire spectrum of responsibility from definition of a potential threat against which a vaccine may be needed through research and development, advanced product development, clinical trials, licensure, manufacture, procurement, and continued maintenance of manufacturing practice standards and regulatory compliance. Fragmented Acquisition Programs for Vaccines and Related Biological Countermeasures for Weaponized and Naturally Occurring Infectious Disease Threats The health of warfighters is at risk both from natural infectious disease threats and from weaponized forms of infectious disease agents that might be intentionally deployed against U.S.
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From page 65... ...
JVAP was intended to streamline acquisition procedures and raise visibility of the need for biodefense products, but these potential benefits have not yet been realized in the acquisition of new vaccine products. The committee could identify no justification for the separation in the acquisition processes for vaccines against naturally occurring and potentially weaponized infectious disease threats.
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From page 66... ...
Any of these options a restructured and reenergized AFEB, a new advisory committee within DoD, or a newly created, ongoing, independent advisory group outside of DoD would provide DoD with a group of senior advisers who could evaluate the priorities and operations of a consolidated DoD vaccine authority and who would have the potential to become strong proponents for the work that DoD does regarding vaccines against infectious diseases of military importance. A respected and well-connected champion could help articulate the needs so that the upper echelons of DoD could better understand them and, therefore, within their own fiscal and political constraints and opinions, act to support these important efforts.
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From page 67... ...
The research requirements and budget decisions for the development of components of the technology base follow a pathway very different from that for advanced product development. The budgeting process is further complicated by a split between activities related to naturally occurring infectious diseases and those related to potentially weaponized biological agents that results in research redundancies and fragmented funding, as discussed above.
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From page 68... ...
Army Medical Research Institute of Infectious Diseases (USAMRIID) , let alone offer protection to troops who could be exposed to these threats in the field.
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From page 69... ...
Table 4-1 shows the somewhat erratic nature of the funding that has supported the DoD infectious disease science and technology base since 1993. From FY 1993 to FY 2000 there were no sustained increases and the budget clearly failed to keep pace with inflation.
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From page 71... ...
, representing only a very small fraction of the resources that the U.S. military needs to acquire licensed vaccines against a large number of potential infectious disease threats.
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From page 72... ...
These advances coupled with enhancements in relevant areas of the nation's research infrastructure are likely to provide significant spin-offs for DoD as it attempts to address militarily important naturally occurring infectious diseases. However, in this atmosphere of increased resources fueled by a heightened awareness of the public's vulnerability to bioterrorist actions, the committee cautions that the United States must sustain its investment in vaccine development activities over many years if it is to successfully develop useful vaccines.
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From page 73... ...
However, the committee found that no such list is available to the Medical Infectious Diseases Research Program. The committee acknowledges that it cannot be certain that having a weighted, prioritized list of disease threats would alter research budget allocation decisions in the short term or the health of troops in the long term.
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From page 74... ...
A formal process for scenario planning would be useful in prioritizing threats based on estimated risk exposures and anticipated outcomes in the event of infection and would provide an effective interface between intelligence agencies and the DoD decision makers who manage the vaccine acquisition process. Scenarios are cited by private industry advisors as more than predictive and decision-making tools, providing participants "within the organization .
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From page 75... ...
2~. The end result of scenario planning would be a prioritized list or database of disease threats weighted by potential importance to military operations and subject to periodic review and modification as the geopolitical landscape evolves over time.
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From page 76... ...
Such a mechanism could involve the use of prioritized, weighted lists of infectious disease threats and formal scenario-planning exercises and would require the use and synthesis of infectious diseases surveillance and epidemiologic information. A Declining DoD Technology Base Limits Vaccine Acquisition Budget competition within DoD pits efforts to build and maintain the military's technology base against projects focused on specific products.
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From page 77... ...
Recommendation 6. Include programming goals that ensure greater strength and continuity in the science and technology base for 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.
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From page 78... ...
This observation strongly informs the committee's own recommendations that the proposed single vaccine authority in DoD have controlling authority for vaccine acquisition, including budgetary authority and adequate funding resources. Such authority is needed to carry a vaccine through the process from an idea to a product that is licensed and continually available.
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From page 79... ...
, which NIH is using to guide it in setting research priorities (NIAID, 2002b) as it prepares to receive the $1.8 billion that the President's proposed budget directs for defenses against bioterrorism, overlap extensively with the agents covered by DoD's research programs on biodefense and naturally occurring infectious diseases.
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From page 80... ...
Government-Industry Relationships and the Economics of Vaccines One of the reasons underlying past failures in DoD's vaccine acquisition efforts is that DoD lacks an ongoing and coordinated relationship with the small number of remaining large vaccine manufacturers3 that collectively possess decades of experience in vaccine development, delivery, and other logistics 3There are four major vaccine manufacturers: Aventis Pasteur, GlaxoSmithKline, Merck, and Wyeth.
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From page 81... ...
The fact that some important vaccines that have been developed in the past and for which the science and technology base is well understood such as the adenovirus and anthrax vaccines have not been available to the military because the manufacturers ceased production or FDA halted distribution makes clear that this is not a theoretical problem but a real one. DoD needs to create stable incentives and contractual obligations for manufacturers to remain motivated and capable of producing vaccines over the long term.
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From page 82... ...
Vaccine development is as complicated for special-use vaccines as it is for those with wider commercial potentials, and thus, with the possible exceptions described above, special-use vaccines are potentially as expensive. An acceptable level of safety must be demonstrated to FDA's satisfaction before licensure.
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From page 83... ...
DoD faces an industrywide lack of interest in the vaccines that it so urgently needs to protect its forces against many infectious disease threats. The committee asked current and past vaccine industry executives to describe the factors that lead manufacturers to avoid the development of vaccines with a limited target population.
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From page 84... ...
There is the risk that additional rules now under consideration may substantially enhance the burdens associated with research on these agents and thus drive both industrial and academic research laboratories toward less regulated areas of research and vaccine development.
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From page 85... ...
The perspectives described above make clear why established, large manufacturers have little interest in developing vaccines that would be used only by the military to protect its forces against infectious diseases and for which a profitable commercial market would not be found in the civilian sector. Meanwhile, although small newcomers to the vaccine industry may be willing to bid on projects of limited scope, such untested partners cannot reliably provide the vaccines that the military requires.
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From page 86... ...
A predictable market would involve the generation and maintenance of a vaccine stockpile, the purchase of guaranteed volumes in the future, and reasonable assumptions regarding pricing. The lack of a policy that is acceptable to industry regarding indemnification against nonnegligent, adverse reactions is a major obstacle to DoD's ability to attract industry participation in the vaccine acquisition process.
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From page 87... ...
A Government-Organized Consortium of Major Vaccine Manufacturers The committee considered the possibility that government-industry partnerships might be managed through an industry consortium that would be formed to deal with the military's requests for special-use vaccines. Such a consortium could be a single industrial vaccine authority working in partnership with the single DoD authority envisioned as described above to distribute the real and intangible costs of military vaccine development among multiple corporate entities in the industry.
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From page 88... ...
The committee notes that as part of an accelerated program of medical biodefense measures the Defense Authorization Act for FY 20027 authorizes DoD to design, construct, and operate a vaccine production facility and to contract for the private production of vaccines there. Evidence supporting the need for a dedicated manufacturing resource can be found in Table 3-5.
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From page 89... ...
However, if the federal government makes a decision to invest capital for the construction of vaccine production facilities, an alternative to the GOCO concept would be to work out arrangements with specific companies, in which the federal government would subsidize construction of vaccine production facilities that the manufacturer could use to produce other vaccines when the facility was not in use for the production of vaccines for the U.S. military.
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From page 90... ...
These arrangements should include consideration of the development of vaccine-specific partnerships between the federal government and individual private manufacturers, a consortium of private vaccine manufacturers, and government-owned, contractor-operated (GOCO) vaccine production facilities.
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From page 91... ...
This typically entails the enrollment of 10,000 or more subjects in Phase III clinical trials. These numbers may be justified for prelicensure studies of vaccines that are to be used universally or in large numbers of recipients, but studies of that size are tremendously difficult to conduct for vaccines whose use by DoD is intended to be restricted to small numbers of individuals (such as potentially exposed military personnel)
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From page 92... ...
It also recognizes that some IND products may never be suitable for licensure. What it does seek is a pragmatic solution to an impossible set of circumstances that threaten to limit access to useful preventive measures during military operations that entail demonstrable risks of infectious diseases.
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From page 93... ...
Immunization is often the most effective means of preventing infectious diseases, either in civilian or military populations, and whether caused by naturally encountered infectious agents or purposeful exposures related to bioterrorism or biological warfare. 8National Defense Authorization Act for Fiscal Year 2002, P.L.
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From page 94... ...
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.
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