currently administered only at USAMRIID, and they must be stored, maintained, and tested periodically for potency (Boudreau 2010). Those factors and the regulatory requirements associated with the clinical protocols that guide the SIP make the special immunizations expensive. In the early 2000s, the high costs and limited availability of SIP vaccines led the Department of Defense (DOD) to restrict enrollment in the SIP of personnel working for or funded by non-DOD agencies unless the costs of participation for these personnel were covered by the non-DOD users. The result was that fewer non-DOD government and civilian academic researchers had access to SIP immunizations at the same time that the population of such researchers was undergoing a rapid expansion.

To address the cost and location issues in the program, a U.S. Homeland Security Council (HSC) policy coordinating committee (PCC) approved an expansion of the SIP in 2004. The U.S. Army Medical Research and Materiel Command (USAMRMC) and USAMRIID were directed to continue conducting an expanded program at Fort Detrick and at one or two new satellite locations. The HSC PCC directed that the program expansion be funded by cost sharing with fully burdened contributions from the using departments and agencies according to their percentage use of the program. However, the non-DOD user agencies did not set aside funds to pay for an expanded SIP accessible to all potential users, and at-risk researchers in non-DOD government and academic settings continued to work without immunization while potentially protective vaccines were available from DOD. In addition, some of the SIP vaccines are nearing the end of their lifespan and may need to be replaced.

In late 2008, the Biomedical Advanced Research and Development Authority (BARDA), in the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS), asked the National Research Council to examine technical issues related to the HSC PCC recommendation for the expansion of the SIP in the larger context of immunization of researchers working with potentially hazardous pathogens and toxins. The present report is the result of that examination.

This chapter sets the SIP and the U.S. biological defense (biodefense) program into context and provides a background for later chapters on specific elements of the program and committee findings and conclusions. The U.S. medical countermeasures enterprise, including military and civilian biodefense priorities and the state of potentially relevant vaccine research, development, and manufacturing, are continually changing. To the best of the committee’s knowledge, the information provided in this report is accurate at the time of publication. After briefing the sponsor, the committee made a limited number of factual corrections and clarifications, none of which affected the conclusions or recommendations.

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