Protecting the Frontline in Biodefense Research The Special Immunizations Program (2011) / Chapter Skim
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6 Potential Options for the Special Immunizations Program and for Personnel Immunization
6 Potential Options for the Special Immunizations Program and for Personnel Immunization
Pages 115-128
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From page 115... ...
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)
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From page 116... ...
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?
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From page 117... ...
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)
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From page 118... ...
However, military and civilian pathogen research priorities are likely to evolve over time and are affected by judgments on emerging public health diseases, endemic diseases 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.
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From page 119... ...
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.
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From page 120... ...
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.
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From page 121... ...
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.
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From page 122... ...
A limited expansion in close partnership with a central administration 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.
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From page 123... ...
. 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.
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From page 124... ...
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.
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From page 125... ...
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.
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From page 126... ...
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.
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From page 127... ...
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 offering immunizations to laboratory workers continues to be one component of an overall biosafety program.
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From page 128... ...
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 governance 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.
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