6
Potential Options for the Special Immunizations Program and for Personnel Immunization

The committee outlined several possible options for the Special Immunizations Program (SIP) during its discussions of the structure of the current program, the role of vaccination for laboratory workers, and potential needs and opportunities. On the basis of its analysis, the committee concluded that a cooperatively governed SIP located at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) would constitute the most effective vaccination program for the community of military and civilian personnel who work with hazardous pathogens while continuing to provide a manageable operational structure (see Option 2, below). The anticipated expansion of facilities as part of the National Interagency Biodefense Campus at Fort Detrick—which will include USAMRIID along with the National Institute of Allergy and Infectious Diseases (NIAID) Integrated Research Facility, the Department of Homeland Security National Biodefense Analysis and Countermeasures Center, and the U.S. Department of Agriculture Agricultural Research Service and Foreign Disease-Weed Science Research Unit—also strengthen the appeal of this option.

The committee recognizes that decisions on the structure of a program like the SIP must take into account multiple factors, some of which are beyond the scope of the committee’s charge. A discussion and comparison of the options considered by the committee are presented below to help inform further conversations.



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6 Potential Options for the Special Immunizations Program and for Personnel Immunization The committee outlined several possible options for the Special Immu - nizations Program (SIP) during its discussions of the structure of the current program, the role of vaccination for laboratory workers, and potential needs and opportunities. On the basis of its analysis, the committee concluded that a cooperatively governed SIP located at the U.S. Army Medical Research Insti - tute of Infectious Diseases (USAMRIID) would constitute the most effective vaccination program for the community of military and civilian personnel who work with hazardous pathogens while continuing to provide a manageable operational structure (see Option 2, below). The anticipated expansion of facili- ties as part of the National Interagency Biodefense Campus at Fort Detrick— which will include USAMRIID along with the National Institute of Allergy and Infectious Diseases (NIAID) Integrated Research Facility, the Department of Homeland Security National Biodefense Analysis and Countermeasures Center, and the U.S. Department of Agriculture Agricultural Research Service and Foreign Disease-Weed Science Research Unit—also strengthen the appeal of this option. The committee recognizes that decisions on the structure of a program like the SIP must take into account multiple factors, some of which are beyond the scope of the committee’s charge. A discussion and comparison of the op - tions considered by the committee are presented below to help inform further conversations. 115

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116 PROTECTING THE FRONTLINE IN BIODEFENSE RESEARCH TABLE 6.1 Summary Comparison of Options Greatest Potential Meet Meet Lowest Worker Most DOD Civilian Relative Greatest Option Protection Flexibility Needs Needs Cost Feasibility 1. Status quo ••• ••• ••• 1a. Status quo with ••• ••• ••• ••• additional funding 1b. Status quo with ••• ••• ••• ••• separate civilian program 2. Cooperative governance, •••• ••• •••• •••• based at Ft. Detrick 3. SIP as a central MCM •••• ••• •••• •••• enterprise component 4. Cancel the SIP •••• •••• Evaluation scale: least to most effective in meeting the objective— - - ••• - ••• 6.1 OPTIONS FOR THE FUTURE OF THE SIP In formulating responses to its statement of task, the committee discussed the implications of several possible options for the SIP program. Criteria on which these options were evaluated include • Worker protection. Does the option provide potential protection to researchers and others who work with hazardous pathogens? • Flexibility. Does the option allow the program to adapt to meet new needs and priorities? • Department of Defense (DOD) needs. Does the option meet the needs of military researchers and other DOD users? • Civilian needs. Does the option meet the needs of civilian users? • Cost. How expensive is the option likely to be in comparison with other options? • Feasibility. How feasible does implementation of the option appear to be in comparison with other options? Four options and two suboptions are discussed in more detail below, and a comparison of them is summarized in Table 6.1 6.1.1 Option 1: Maintain the Special Immunizations Program in Its Present Form (Status Quo) The current SIP provides a benchmark against which to compare the im - plications of possible program changes. In its current form, the SIP is operated

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117 POTENTIAL OPTIONS FOR THE SIP AND FOR PERSONNEL IMMUNIZATION by the U.S. Army Medical Research and Materiel Command (USAMRMC) through USAMRIID and USAMMDA, and located at Fort Detrick, MD. The program provides access to licensed vaccines against six diseases and to eight investigational vaccines. The cost for each user to participate in the program is about $10,000–15,000 per year. Approximately 600 participants per year are enrolled: 395, or about 60%, at USAMRIID and an additional 228, about 40%, from other DOD units, other government agencies, and external organizations (Boudreau 2010). The operation of the current SIP is discussed in detail in Chapter 3. Worker protection: The SIP as currently conceived provides an additional layer of biosafety protection for a subset of military and civilian personnel who work with certain highly hazardous pathogens. Those who are most effectively covered under the current SIP are those who are working directly with the pathogens and toxins that are currently included in the SIP and working in an agency or organization that is able to support the costs of their program enrollment. The committee noted that participating agencies at the time of the 2004 Homeland Security Council Policy Coordination Committee decision establishing a cost-sharing arrangement for the SIP estimated that 1,000–5,000 workers in BSL-3 and BSL-4 laboratories might be candidates for occupational vaccination and that NIAID’s estimated use alone would grow to 1,800 workers by 2010. In contrast, the committee noted that SIP use has remained relatively constant since 2004 at about 600 users per year; thus, a number of potential users are not accessing the current program and there may be insufficient worker vac - cination coverage of the larger medical countermeasures (MCM) enterprise . That stasis may reflect such factors as the cost to participate in the SIP program and a misalignment of the current SIP vaccines with the pathogens and toxins of most interest to civilian biodefense researchers. Flexibility: The investigational vaccines currently included in the SIP were manufactured at the Salk GSD facility in Swiftwater, PA, which closed in 1998. The current SIP vaccines largely reflect the needs and priorities of historical DOD biodefense research programs and no new vaccine stocks for the program are being generated. The committee noted that new vaccines have periodically been incorporated into the SIP, particularly as licensed products have become available. The replacement of the previous investigational calf lymph smallpox vaccine with ACAM 2000 in 2007 is a successful example. A vaccine against Junin virus, which causes Argentine hemorrhagic fever, also underwent initial development and human clinical trials at USAMRIID and was produced in pilot lots by the Salk GSD (Maiztegui et al. 1998). However, the Junin vaccine was later removed from the SIP because Junin was not considered a threat of interest to DOD despite its inclusion in the Select Agents and Toxins list, the NIAID Category A pathogens, and its consideration as an HHS priority pathogen for countermeasure development. The development and removal of the Junin vaccine from the SIP appears to reflect a limitation in the current

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118 PROTECTING THE FRONTLINE IN BIODEFENSE RESEARCH mandate of the DOD-operated program to meet the vaccination needs of both military and civilian laboratory workers. The committee noted the recent substantial investments made by the United States in developing MCM to meet military and civilian needs. However, military and civilian pathogen research priorities are likely to evolve over time and are affected by judgments on emerging public health diseases, endemic dis- eases in regions of potential military deployments, and assessments of probable bioterrorist or bioweapons threats. The committee is not aware of systematic governance mechanisms to evaluate the current portfolio of vaccines in the SIP or of clear processes to add new vaccines in response to shifting military and civilian hazardous pathogen research priorities. As a result, fundamental strategic aspects of the SIP program appear to have remained fairly static over time, despite reviews that have addressed operational needs such as site location and cost (for example, the 2004 review and HSC PCC decision that did not explicitly consider future vaccine or manufacturing issues in the SIP beyond the potential need for production of new clinical lots from existing stocks). The lack of an established process to allow for program evolution, particularly a governance mechanism to include both civilian (HHS and USDA) and military (DOD) stakeholder perspectives, appears to be an important limitation of the current SIP. DOD needs: The SIP has historically operated under DOD and its original mandate was to offer occupational vaccine protection to military biodefense personnel. The vaccines currently included in the SIP largely reflect that history. The SIP clinic and operational home for the program remain at USAMRIID and about 60% of current SIP users are USAMRIID personnel. As a result, those able to benefit most directly from enrollment in the SIP are USAMRIID researchers. Although the current SIP appears to function sufficiently in meet - ing the current needs of USAMRIID and other DOD programs, the committee noted that this may not remain the case without the ability of the SIP to adapt and evolve. The DOD mandate is primarily to support the development of products that will meet the needs of warfighters. The subset of pathogens of most interest to DOD will continue to include those in the current SIP (such as Bacillus anthracis, which causes anthrax), but also others, such as Ebola virus, that are not included in the current SIP. As DOD priorities change and are subject to the natural emergence of new infectious diseases on a global basis, and as DOD researchers focus their efforts on the most current high-priority pathogens and toxins, the ability of the SIP to meet DOD needs as effectively as it has in the past may decrease. Civilian needs: The current SIP framework allows civilian personnel to participate through a cost-sharing arrangement. Civilian researchers thus have access to the benefits provided by the SIP as long as their agency or organiza - tion is willing to support the costs of their enrollment. The committee noted that investments in civilian biodefense research have grown substantially during

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119 POTENTIAL OPTIONS FOR THE SIP AND FOR PERSONNEL IMMUNIZATION this period. However, there has not been an equivalent growth in civilian SIP participation, and total SIP enrollment has remained static at about 600 a year. That stasis may reflect multiple factors, including the cost to participate in the SIP program and a misalignment of the current SIP vaccines with the patho - gens and toxins of most interest to civilian biodefense researchers. Anecdotally, SIP enrollment costs have discouraged some potential users from considering participation in the program (Pouch Downes 2010). Cost: The most important costs associated with the current SIP include personnel expenses related to clinical trial execution, ongoing medical monitor- ing and regulatory compliance, vaccine stockpile maintenance and testing, and facilities expenses. The costs total approximately $9 million a year and each SIP enrollee is required to pay about $10,000–15,000. The SIP program is not inexpensive. On the other hand, the investments to maintain the program are small compared with the substantial amounts of money invested in the overall biodefense and MCM efforts. Feasibility: The current SIP is administered from a central location at USAMRIID. Participants must travel to Fort Detrick for vaccine administra - tion, although not all vaccines require multiday stays. In addition to on-site immunization, medical monitoring to document immunologic responses or to report adverse events is also accomplished by a physician associated with the enrollee’s home organization. Until 1999, the SIP also included 117 satel - lite sites. During that period, administration of investigational vaccines to SIP enrollees was considered to be exempt from Investigational New Drug (IND) protocol regulations. However, the requirement in 1997 to meet Food and Drug Administration (FDA) IND regulations would have required recruitment of co-investigators, training, site audits, medical monitoring, and other measures that were beyond the capability of the program without major revisions and increased costs. Because of problems with regulatory documentation and com - pliance under the former system of multiple sites, the SIP is now operated at a single site. The current SIP builds on the history and program expertise housed at USAMRIID and USAMMDA, which have demonstrated that they have the operational expertise to manage the program, including administering the vaccines and maintaining compliance with the IND protocols for the investi - gational products in use. The requirement to travel to a central location is less convenient for non-USAMRIID users and contributes to the cost for these users to participate—a situation that appears to ensure IND compliance but presents barriers for use by the non-USAMRIID institutions that wish to avail themselves of the SIP program Conclusions: The current SIP provides a baseline against which to compare other possible options. It operates as a small, self-contained program that is currently not well integrated into other MCM and biodefense investments. It appears to work most effectively for DOD and USAMRIID workers and for

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120 PROTECTING THE FRONTLINE IN BIODEFENSE RESEARCH a relatively small group of researchers unaffiliated with DOD. However, the committee was not convinced that the current program has sufficient adapt - ability to meet new needs and priorities. It is also not sufficiently integrated into ongoing, strategic discussions of the development and manufacturing of next-generation MCM, and the mandate and user base of the current program do not reach many civilian personnel in both the medical and veterinary fields who work with highly hazardous pathogens and theoretically could make use of this type of occupational immunization program. Option 1a: Maintain the Special Immunizations Program in Its Current Form but with Additional Resources The committee also considered the potential outcomes if the SIP were maintained in its current form but were provided with additional financial resources to help supplement the funds raised by the current cost-sharing arrangement. Such resources could be used to meet ongoing expenses for maintenance of the current SIP vaccine stocks, to expand the range of vac- cine offerings, or to help support SIP enrollment for additional public health or other civilian researchers who are not enrolled currently due to budgetary constraints (although this would present additional complicating factors in prioritizing which potential users would receive subsidized participation). However, the committee considered that simply adding money to the cur- rent program fails to address more fundamental needs and opportunities for the SIP. For example, such a choice fails to provide a path to better integrate SIP into other biodefense and medical countermeasures development programs and does not address the need for a SIP governance mechanism of regular strategic review and program evolution. Option 1b: Maintain the Special Immunizations Program in Its Current Form and Encourage the Development of a Separate Civilian-Focused Personnel Vaccination Program The current SIP appears to best address the needs of USAMRIID users, but does not include robust participation from other civilian and public health workers. The committee also discussed the possibility of two independent worker immunization programs, an option that was also considered by the 2004 SIP subgroup. Most of the expansion in research and development of medical coun- termeasures for civilian use, along with increased capacity for public health diagnosis and surveillance against highly hazardous infectious diseases, has been supported by the HHS. As discussed in Chapter 2, the ethical principle of beneficence supports offering workers the option of immunization, if available, as an additional layer of biosafety protection to further reduce the risk to which

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121 POTENTIAL OPTIONS FOR THE SIP AND FOR PERSONNEL IMMUNIZATION they are exposed when working with hazardous pathogens and toxins. HHS thus has an obligation to consider the immunization needs of the researcher community supported by its significant financial investment in these areas. It is also necessary to consider the needs of the veterinary community (lab workers, public health personnel, and veterinary vaccine manufacturers), and to ensure integration of the SIP program with the USDA. The SIP could continue to exist in its current form to meet the needs of the limited, largely USAMRIID-based, population who now benefit from it. A fully independent program could be developed under HHS (and to include USDA) with a mandate to meet the needs of civilian researchers, some of whom may be working on pathogens and toxins that are not covered under the current SIP. Although this option would expand access to personnel vaccination, the committee was concerned that such an option would lead to an inefficient duplication of resources since USAMRIID already possesses the knowledge base to successfully operate a worker immunization program. 6.1.2 Option 2: Institute a Cooperatively Governed Special Immunizations Program Based at the U.S. Army Medical Research Institute of Infectious Diseases The committee considered whether there were alternative ways to envi - sion the SIP, and discussed whether these options might address the perceived limitations in the current program. A reimagined SIP could continue to draw on the operational expertise and history of SIP management by continuing to house the program in USAMRIID. To meet the needs of both military and civilian research communities effectively, however, a more explicit partnership of shared governance could be developed among DOD, HHS, and USDA. The governance mechanism would need to incorporate regular review of the vaccines included in the SIP, periodic assessment of U.S. and international vac - cines and medical countermeasures reaching such developmental milestones as IND or licensed status, and recommendations on specific vaccines that should be added to or removed from the program. For example, an external assess - ment of the SIP in 2002 suggested that the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) play a role in determining worker immunization policy (Boudreau 2010). ACIP currently makes recommendations on the use of licensed vaccines, includ- ing some vaccines of relevance to health-care or laboratory workers, such as anthrax, smallpox, and Japanese encephalitis, but does not address the use of vaccination with IND products. The committee judged that a system of broader stakeholder input into the SIP and shared governance would help to incorpo- rate perspectives from relevant HHS agencies including NIH and CDC. This option would focus on the same fundamental mandate as the current SIP but

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122 PROTECTING THE FRONTLINE IN BIODEFENSE RESEARCH seek to recognize and serve the growth in civilian pathogen and MCM research and engage this community more effectively. Worker protection: In the near term, this option would provide potential worker protection equivalent to the current SIP by offering the same suite of vaccines and operating from the existing offices at USAMRIID. Over the longer term, the committee concluded, worker protection would be enhanced by this option. By providing a governance mechanism that engaged DOD, HHS and USDA and a system of strategic program reviews, the option enables the SIP to evolve to ensure that it remains aligned with national research priorities and developments. Flexibility: The option provides greater flexibility than the current SIP because of the proposed system of shared governance, review, and oversight. The committee noted that the current investigational vaccines administered in the SIP are no longer being manufactured. Although the remaining stocks are sufficient to meet current demand for the foreseeable future, they may eventu - ally run low or lose their potency. The current investigational vaccines were produced with older techniques and more limited knowledge of potential im- munization targets. As a result, some of the vaccines in the program are more reactogenic and less effective than other vaccine products available outside of the United States or vaccine products that may be developed in the future. As such products are developed, a system needs to be in place to consider whether they should be incorporated into the SIP; if so, a clear pathway needs to be established by which to accomplish and fund these acquisitions. The committee also considered the utility of a limited expansion of SIP lo - cations to include regional immunization sites (an option that was also proposed by the 2004 SIP subgroup). The committee suggested that a small number of satellite clinic locations could reduce travel and costs for other participating institutions. A limited expansion in close partnership with a central administra- tion at USAMRIID might avoid the compliance issues previously experienced with immunizing at 117 locations and increase the flexibility and use of the program. In the spirit of presenting several possible examples, potential loca - tions for such satellite sites might draw on the network of Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases and Regional Biocontainment Laboratories, or on the eight NIAID Vaccine and Treatment Evaluation Units, although the committee noted that it would be valuable for satellite locations to be sufficiently geographically diverse. Another option might be for SIP personnel to periodically travel to a few regional locations, a model similar to that used occasionally in outbreak responses. DOD needs: This option would allow the SIP to continue to meet DOD needs, and drawing on the current SIP expertise, staff, and facilities through USAMRIID should minimize disruptions. Ensuring that DOD maintains a strong voice in SIP planning should also ensure that the SIP vaccinations

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123 POTENTIAL OPTIONS FOR THE SIP AND FOR PERSONNEL IMMUNIZATION continue to be aligned with the needs and priorities of military researchers and others supported through DOD contracts. Civilian needs: By creating a mechanism for stronger and more direct HHS and USDA engagement in SIP governance, this option should also ensure that the needs of civilian researchers are better addressed by the program. Cost: The program could continue to be operated as the current SIP is with a central administrative base at USAMRIID and a cost-sharing arrange - ment among the participating agencies. By providing such agencies as HHS and USDA with a mechanism for direct participation in program planning, the option might encourage agencies to be more willing to cover enrollment costs for researchers supported by them. If expansion to a small number of regional sites is implemented, costs would probably increase beyond those of the current program. However, as noted in Chapter 4, there may be additional regulatory options that could be pursued to enable immunizations off-site from USAMRIID (for example, with investigator-initiated IND’s cross-referencing a USAMRIID primary IND). The committee recognizes that implementing a shared DOD-HHS-USDA SIP governance system will probably entail costs and challenges and that this option may be more expensive than the current SIP. For example, there will probably have to be periodic meetings of a review and oversight board to make decisions about new SIP vaccine acquisitions or vaccines to eliminate from the program. If additional vaccines are brought into the program (perhaps pur- chased from DOD or HHS-contracted vaccine manufacturing facilities), there will be additional costs associated with administering the vaccines, maintaining necessary regulatory documentation, and ensuring vaccine supplies. In contrast, if the program is able to transition to greater use of licensed products (as these are developed through the MCM research pipeline), there may be lower costs associated with administration of licensed vaccines and a decreased need to maintain more burdensome IND protocols. Feasibility: This option will be more complicated than the current SIP because of the need for shared oversight by DOD, HHS, and USDA. How - ever, the committee considered that the current program location at Fort De - trick provides special advantages that make achieving synergy within the SIP more valuable and more feasible. DOD and HHS have already increased their communication and collaboration through the Integrated Portfolio for CBRN Medical Countermeasures (Newmark 2009). Several agencies are also develop - ing new facilities as part of the National Interagency Biodefense Campus at Fort Detrick, which will include USAMRIID and the NIAID Integrated Research Facility, the DHS National Biodefense Analysis and Countermeasures Center, and the USDA Agricultural Research Service and Foreign Disease-Weed Sci - ence Research Unit. The committee also noted that certain investigational vaccines of potential interest to the SIP may be available under IND protocols maintained by federal agencies outside of USAMRMC. It may be possible to

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124 PROTECTING THE FRONTLINE IN BIODEFENSE RESEARCH consider cooperative options under which laboratory workers needing an im - munization for which another agency holds an IND are directed to that agency, a situation that may be made more feasible if agencies such as DOD, HHS, and USDA are collaboratively involved in setting the strategic priorities of the SIP. Conclusions: Although this option suggests the need for substantial changes in the SIP, the committee concluded that the addition of a more structured governance system reflecting the needs of both civilian and military research communities, mechanisms to enable the SIP to evolve as needed and continued operation at USAMRIID and USAMMDA to take advantage of the administra- tive history and program expertise offer advantages that could counterbalance additional cost and logistical concerns. Such an option may offer a feasible response to many of the current SIP limitations while minimizing program disruptions and building on momentum generated by ongoing, multiagency collaborative projects as part of the overall U.S. MCM enterprise. The com - mittee concluded that USAMRMC may be uniquely positioned to continue to implement the SIP under these circumstances and that this option could best meet the ethical obligation to continue offering immunizations to personnel working with highly hazardous pathogens, to implement a system serving both the military and civilian user communities, and to establish a system that can adapt and evolve over time. 6.1.3 Option 3: Position the Special Immunizations Program as a Central Component of the National Preparedness Enterprise As discussed above, because the SIP is the vehicle that provides occu - pational vaccines to personnel who work with hazardous pathogens it sits at a clear intersection between military and civilian biodefense enterprises. In addition to the direct potential occupational health benefit that the SIP pro - vides to researchers who handle certain pathogens and toxins, the existence of the SIP contributes to the advancement of science in several broader ways. It is possible to conceive of a SIP that develops those broader missions more explicitly so that it serves a more central role as a test bed in the overall MCM enterprise. For example, the ongoing medical monitoring of those who receive SIP vaccines and the collection of safety and immunogenicity data can be an invaluable resource for • Identifying safe products. • Expanding knowledge about human immune responses to immunization. • Furthering the development of safe and effective vaccines beyond IND status (as part of the documentation needed for FDA approval). • Providing a benchmark of performance for comparison in the develop- ment of the next generation of vaccine products. • Gathering data in the event of a need for Emergency Use Authorization.

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125 POTENTIAL OPTIONS FOR THE SIP AND FOR PERSONNEL IMMUNIZATION Having a ready supply of vaccines against a variety of Select Agents and other highly hazardous pathogens also means that immunoglobulin can be produced by immunizing healthy plasma donors to produce a treatment for nonimmunized people in the event of an exposure. Key components of a comprehensive national preparedness strategy include the infrastructure and human capital to rapidly respond to needs for vaccine and the deployment of immunized individuals in the event of a bioterror incident. A SIP can provide a clinical test bed that can help to enable rapid and coordinated responses to natural and human-made biological threats to national security. Worker protection: While expanding the mandate of the SIP, this option would continue to meet its core mission of providing immunizations to at-risk researchers. As a result, it would continue to provide an equivalent level of additional potential protection for workers through immunizations as the cur- rent SIP. Flexibility: A SIP reconceived as a central component of biodefense and MCM investments, and adequately supported, would be responsive to the fu - ture needs of the military and civilian biodefense efforts. DOD needs: As in other options, the SIP would continue to meet DOD needs. Ensuring that DOD maintains a strong voice in SIP planning should also mean that the SIP vaccinations would continue to align with the needs and priorities of military researchers and others supported through DOD contracts Civilian needs: As in option 2, a SIP that included stronger and more di- rect HHS and USDA engagement should ensure that the program meets the needs of civilian researchers. Such a program would also assure the general public that the nation is better prepared to address natural and human-made biological threats. Cost: Conceiving of the SIP as a central base in the MCM enterprise would require additional resources for management and administration, implementa - tion, and coordination. It seems probable that an occupational immunization program conceived with this type of expanded mission would cost much more than the current SIP. Feasibility: The committee concluded that feasibility would be an impor- tant obstacle to implementation of this option. The existing SIP is designed to meet a limited set of needs for a defined user community and is not organized to meet a greatly expanded mission as a central component of the national MCM enterprise. The mandate of developing, testing, and manufacturing new vaccines and medical countermeasures also falls to multiple existing and pro - posed programs. The committee observed that the SIP has never played the type of central role implied by this option, even within the portfolio of DOD biodefense programs, and that the SIP has struggled to find sufficient financial support to maintain even fundamental components such as current vaccine stockpile management. Over the recent course of its history, the SIP has failed to generate the enthusiasm that would be needed for it to assume a central role

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126 PROTECTING THE FRONTLINE IN BIODEFENSE RESEARCH in national preparedness, and the committee judged it extremely unlikely that the SIP would be positioned to become this type of keystone program now. Conclusions: The primary mandate of the SIP has historically been and remains provision of vaccines against a subset of hazardous pathogens to those personnel who are occupationally at risk for infection. The SIP remains a small but well-defined component of the overall U.S. MCM enterprise. Over the previous decade or more of its existence, enrollment in the SIP has remained at roughly 600 users a year and financial and strategic investments in the SIP have been limited. Although the additional vaccine safety and immunogenicity data generated by the SIP, particularly the longer-term follow-up data, consti - tute a benefit that should be used by vaccine developers and manufacturers to the greatest extent possible, the SIP is unlikely to be in a position to serve as an ambitious central test bed for the larger MCM enterprise. The committee concluded that it is not feasible for the SIP to assume this additional role. 6.1.4 Option 4: Cancel the Special Immunizations Program The committee considered the question of whether a SIP was still needed and what the implications of canceling the program might be. It concluded that cancelling the SIP would lead to avoidable harms. Worker protection: The SIP maintains, provides, and administers a program to support the availability of occupational vaccines, which are a key component of a comprehensive strategy to promote the highest standards in biosafety and disease prevention safeguards for protecting laboratory workers from the risk of disease in handling high-risk pathogens. High-risk pathogens can cause serious, potentially fatal disease through aerosol and percutaneous exposures. Immunization remains a proven part of an overall protection strategy that includes engineering control measures, safety training and the use of personal protective equipment. Despite training in safe laboratory practices, the risk of needlesticks and exposure to other sharp instruments and injury by laboratory animals cannot be entirely eliminated and immunization offers a final level of potential protection for such exposure. As discussed in Chapter 2, offering personnel who work with hazardous pathogens and toxins the option of im - munization as a part of a program of biosafety measures remains a standard of best practice and an ethical obligation. Canceling the SIP would leave a gap in worker occupational health protection and would probably shift the medical monitoring currently conducted through the SIP to community physicians or to occupational health programs at the worker’s institution who are unfamiliar with the hazardous agents and the vaccine products. Having a program such as the SIP that provides licensed and investiga - tional vaccines to individual laboratory workers also provides potential social and population-level benefits that would be lost were the program to be can - celed. For example, the committee noted that potential laboratory exposures

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127 POTENTIAL OPTIONS FOR THE SIP AND FOR PERSONNEL IMMUNIZATION might lead to infections in a worker that could be spread to family members or to the community. Although uncommon, such a situation is not impossible and transmission of laboratory-acquired Brucella infection to a spouse has previously been reported (Ruben et al. 1991). The medical monitoring and collection of blood samples through the SIP may help to identify asymptomatic infections, and the safety and immunogenicity data collected through the SIP might be of use to regulatory authorities both for comparison with newly de - veloped vaccines and in helping to support emergency use of a vaccine should such a situation arise. In addition, a number of publications have resulted from the data collected by administering investigational vaccines through the SIP. These include stud - ies to investigate details of the human immune response and mechanisms of action of particular vaccines (McClain et al. 1998; Pittman et al. 2005b; Fuller et al. 2007; Rusnak et al. 2011), to examine long-term health trends among recipients of investigational vaccines (Pittman et al. 2004, 2005a), to analyze information on laboratory exposures to pathogens (Rusnak et al. 2004a,b), and others. These studies have provided a wealth of valuable information to the research community. Flexibility: Canceling the program represents an inflexible solution to the limitations perceived in the current SIP. Canceling the program would also result in a loss of the program operational and administrative expertise housed within USAMRIID and USAMMDA while failing to provide a pathway for at-risk personnel working in a biohazardous environment to receive relevant investigational vaccines. DOD needs: As discussed in Chapter 2, the committee judged that offer- ing immunizations to laboratory workers continues to be one component of an overall biosafety program. Canceling the program would not meet the respon - sibilities of DOD to offer this additional measure of potential protection to its researchers working with hazardous pathogens. Civilian needs: Canceling the program would mean that the needs of civil- ian researchers who work with hazardous pathogens would not be met. Cost: The committee was unable to conduct a detailed financial assess- ment of the benefits provided to workers by SIP immunizations, beyond the levels of protection provided by other forms of biosafety, compared with the costs of operating the program. Canceling the SIP is the most cost-favorable option with respect to direct program costs. Eliminating the program and the associated IND maintenance and medical monitoring that are required would save about $9 million per year (see Chapter 3 for discussion of the current cost structure of the SIP). In contrast, if a hazardous pathogen researcher contracted a laboratory-associated infection that might have been prevented through SIP immunization, agencies might face additional costs in treating this infection, in lost worker productivity, and in reassuring the public, costs that could have been saved if the SIP were available (the cost of not having a program). It is

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128 PROTECTING THE FRONTLINE IN BIODEFENSE RESEARCH possible that the loss of this resource would result in a reduction in the coun - termeasure research enterprise, given concerns about liability among employ - ers and personal safety among laboratory workers. In addition, the committee noted that the SIP has value beyond individual worker immunization. The SIP serves as a resource on safety and immunogenicity information of all vaccines used in the program. Such data may have substantial value in a future national biodefense emergency. Publications arising from the SIP have also contributed to biosafety practices. Feasibility: Challenging issues that need to be addressed within the current SIP, such as maintenance of vaccine stocks and compliance with IND regulatory requirements, could be avoided if the SIP were canceled. Although it may be feasible or even tempting to cancel the program, the committee concluded that the issue of the best way to protect the population of personnel working with hazardous pathogens as part of biodefense, MCM, and public health invest - ments will remain and must be addressed in some fashion. Conclusions: As discussed in Chapter 4, the committee noted that access to the licensed vaccines currently included in the SIP would be possible through other mechanisms were the SIP to be canceled. However, canceling the SIP would prevent access to the investigational vaccines it contains, which may offer an additional level of protection to researchers and remain an important component of an overall biosafety program. Despite potential cost savings and the possibility of avoiding challenging strategic questions about SIP gover- nance and evolution, the committee strongly concluded that this option fails to meet an ethical duty to provide the option of immunization to personnel who work with hazardous pathogens where licensed or investigational vaccines are available. In addition, the SIP remains an essential component of our national countermeasure efforts. 6.2 CONCLUSION ON POTENTIAL OPTIONS FOR THE SIP The committee concluded that a cooperatively governed SIP located at USAMRIID would constitute the most effective vaccination program for the community of military and civilian personnel working with hazardous patho - gens while continuing to provide a manageable operational structure.