Protecting the Frontline in Biodefense Research The Special Immunizations Program (2011) / Chapter Skim
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3 The U.S. Medical Countermeasures Enterprise and Recent Reviews and Current Operation of the Special Immunizations Program
3 The U.S. Medical Countermeasures Enterprise and Recent Reviews and Current Operation of the Special Immunizations Program
Pages 43-76
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enterprise, so its effectiveness must be considered in this broader framework 3.1 THE U.S. MEDICAL COUNTERMEASURES ENTERPRISE Overarching U.S.
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Department of Homeland Security DOD U.S. Department of Defense JPEO-CBD Joint Program Executive Office for Chemical/Biological Defense JRO Joint Research Office JSTO Joint Science and Technology Office NIAID National Institute for Allergy and Infectious Diseases NIH National Institutes of Health OPEO Office of Preparedness and Emergency Operations PHEMCE Public Health Emergency Medical Countermeasures Enterprise TMT Transformational Medical Technologies Program TPP Target Product Profiles FIGURE 3.1 Government agencies involved in the civilian and military MCM pathway.
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The military MCM pipeline is complex, with important research and de velopment roles played by the DOD Chemical and Biological Defense Program (CBDP) , the Defense Advanced Research Projects Agency, the Joint Science and Technology Office for Chemical and Biological Defense (JSTO)
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For instance, the February 2010 report from the National Biodefense Science Board (NBSB) , Optimizing Industrial Involvement with Medical Countermeasure Development, contains "Table 1: Top Priority Medical Countermeasures (MCMs)
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. Junin virus (therapeutic use)
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3.3.1 The Military Medical Countermeasures Enterprise Since the report to the deputy secretary of defense by an independent panel of experts (referred to as the Top Report) in 2001, there have been sev eral external analyses of DOD's biodefense programs and strategies for MCM (Top et al.
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The 2003 implementation plan was intended to streamline operations and resulted in the creation of the JPEO-CBD executed by the Army and JSTO-CBD responsibilities in DTRA. 3.3.2 The Civilian Medical Countermeasures Enterprise Recent reports have also reviewed issues in the civilian MCM pipeline.
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. The recommendations made in those military and civilian countermeasures reports highlight special challenges inherent in the development of vaccines and other countermeasures against biothreat agents and emerging infectious diseases, including limited commercial markets, the difficulty of conducting clinical trials and following a traditional path to FDA licensure, and a need to continue anticipating and addressing new and emerging threats.
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. "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" (IOM 2002)
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. "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" (IOM 2002)
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and the structure and operations of the current program in the context of ef forts to review the overall MCM enterprise. As noted in Chapter 2, immunizations provided through the SIP consist largely of legacy investigational vaccines produced by the Salk Institute Government Services Division (TSI GSD)
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The SIP subgroup held five meetings to develop options, refine program costs, and validate enrollment projections; held executive briefings on its interim report for the commander of USAMRMC, the director of CDC, the director of NIAID, the commander of the U.S. Army Medical Command and the Army surgeon general, the deputy assistant secretary for defense for chemi cal and biological defense, the assistant secretary of defense for health affairs, DHS, the Office of Science and Technology Policy, and the associate administrator of the USDA Agricultural Research Service; held five interim meetings with the U.S.
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, and on December 16, 2004, the chair of the SIP subgroup, Edward Eitzen, briefed the U.S. Homeland Security Council Policy Coordinating Committee (HSC PCC)
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• Variable costs for program expenses related to different vaccines, which reflect the number of doses required for the primary series, the number of protocol-mandated follow-up visits, and the number of booster vaccinations anticipated per year (no charge is assessed for the investigational vaccines themselves)
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. In his 2004 briefing paper, the subgroup chair noted that four additional IND vaccines might be of potential interest to the SIP (for Chikungunya virus, Hantavirus, Junin virus, and tickborne encephalitis virus)
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In summary, both the 2002 and 2004 reviews of the SIP recommended that an expanded SIP be implemented to include workers in government agencies beyond the Army, both federal and state, and academe and industry. 3.5 THE CURRENT SPECIAL IMMUNIZATIONS PROGRAM 3.5.1 Scope and General Structure of the Program The committee noted that the SIP is the only program in the United States that provides investigational vaccines for laboratory workers exposed to haz ardous pathogens and toxins.5 Although the SIP was conceived in support of laboratory personnel working at what is now USAMRIID, program reviews and agreements have expanded the array of participating organizations.
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USAMRIID, should decide on use of IND vaccines at the national level. WMDMC Subcommittee, Recommended SIP expansion with Army managing program on a SIP subgroup (2004)
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3.5.2 Special Immunizations Program Customers At the time of the 2004 agreement on the proposed SIP expansion and agency cost-sharing arrangements, about 600–800 participants were enrolled in the SIP. HHS, however, had substantially increased funding for research related to biodefense, largely through NIAID.
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. It is unclear whether the decline reflects a decrease in laboratory workers who require immunization or is due to the high cost and inconvenience of the SIP program, which discourages participation.
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As noted in Chapter 1, BARDA's other sig nificant mission focuses on the advanced development, and acquisition under Project Bioshield, of vaccines and therapeutics for civilian use against CBRN threats, particularly anthrax, smallpox, and botulinum toxin. 8 Although vaccines against those diseases are included in the current SIP, licensed products for anthrax and smallpox exist, and the IND for at least one product against botulinum toxin is held by CDC.
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maintained under IND status. Tables 3.3 and 3.4 list current investigational and licensed TABLE 3.3 Current SIP Vaccines (IND)
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sanofi pasteur SIP vaccines, respectively, and Table 3.5 provides information on vaccine characteristics. All but one of the IND vaccines in the SIP are lyophilized prepa rations stored at –20°C ± 10°C.
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boosters EEE Days 0, 28 65–70% primary; Mandatory 6 mo, 10–15% 10% 85–90% booster then as needed according to titer (1:40) Rift Valley Days 0, 7, 28, 79% primary As needed 8–10% 3–5% fever 180 series; 96% booster according to titer response (1:40)
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3.5.5 SIP Vaccine Supply and Stockpile Management The bulk of the SIP vaccine supply is made up of legacy vaccines manu factured at the Salk Institute vaccine-production plant in Swiftwater, PA, in the 9 As noted earlier, use of Q fever vaccine is limited by skin test availability.
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Numerous lots are available for most of the SIP investigational vaccines, and conservative estimates of IND vaccine supply range from 10 or 11 years for Rift Valley fever lots to 73 years for some VEE and EEE lots (see Table 3.4)
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. Although some of these considerations might apply to licensed vaccines and to vaccines developed using today's technology, these may be greater con cerns given that the SIP IND vaccines were largely developed decades ago prior to the establishment of modern cGMP standards.
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In addition, the data on safety and immunogenicity accumulated through the SIP IND clinical trials could be used to enable FDA to make a determination for an Emergency Use Authorization if this is required. 3.5.6 Costs of the Special Immunizations Program According to SIP leadership, entry into the SIP program currently costs about $10,000–15,000 per volunteer per year (depending on the number and type of SIP vaccines needed)
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The SIP operates on a pay-as-you-go basis, and funding to support the 12 In generating these cost projections, the 2004 SIP subgroup obtained cost estimates from relevant providers. For example, quotes were provided by SRI, Q-One Biotech, BioReliance, and USAMRIID for product testing; quotes for vaccine storage were provided by JVAP; and quotes for regulatory documentation were obtained from SAIC, USAMRIID, Quintiles, and Parexcel.
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. 3.5.7 Governance of and Priority-Setting in the Special Immunizations Program As discussed in Section 3.2, national priorities for military and civilian MCM are currently set separately from the process of governance that de termines the current and future capabilities of the SIP.
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and Giving Full Measure to Countermeasures: Addressing Problems in the DOD Program to Develop Medical Countermeasures (2004) , which described the DOD vaccine development and acquisition process in place at the time and recommended creation of a single agency in DOD to streamline matters.
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3.6 FINDINGS AND CONCLUSIONS ON THE MEDICAL COUNTERMEASURES ENTERPRISE AND THE CURRENT SPECIAL IMMUNIZATIONS PROGRAM During the last decade, numerous outside reviews of military and civilian biodefense vaccine programs have recommended a substantial increase in the funding of and the priority given to these programs, including the establishment of production facilities and agencies that have oversight functions to direct the efforts. More recently, recommendations have been offered to create incentives for industry and the private sector to establish better collaboration with govern ment and academe and to overcome regulatory obstacles.
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The supply of investigational vaccines in the SIP is sufficient for the immediate term but will be more rapidly depleted if additional participants enter the SIP and require immunizations. The current SIP clinical lots may be unable to accommodate the additional demand from all laboratory workers at risk for exposure.
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A mechanism by which requests to include such vaccines are considered should be implemented. • Finding 7: The SIP lacks consistent funding, including a lack of line items in USAMRIID and other agency budgets to support continued maintenance of the existing stockpiles, vialing additional bulk vaccine from existing stocks, and costs associated with acquiring new vaccines for inclusion in the SIP.
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