Protecting the Frontline in Biodefense Research The Special Immunizations Program (2011) / Chapter Skim
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Pages 1-6
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Its mission is to provide additional protection through vaccines to at-risk personnel, to ensure the safety and well-being of program participants through continuous medical evaluation, to provide evaluation and treatment of occupational exposures, and to collect safety and immunogenicity data to further medical research on these vaccines. The SIP is designed to augment the protection provided by other components of laboratory biosafety, including best practices, engineering controls, and personal protective equipment for working with hazardous pathogens.
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As a result of its deliberations, the committee arrived at a series of findings and corresponding recommendations about the SIP and the general role of im munization in the context of hazardous pathogen research in the United States. HISTORICAL VALUE OF THE SPECIAL IMMUNIZATIONS PROGRAM The SIP has played a significant historical role in offering additional pro tection to laboratory workers involved in U.S.
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EXPANSION OF THE SPECIAL IMMUNIZATIONS PROGRAM TO MEET CIVILIAN NEEDS AS WELL AS MILITARY NEEDS The SIP is the only formal program in the United States, and probably in the world, that exists to provide vaccines (both licensed and investigational) to at-risk laboratory workers and other occupationally exposed personnel work ing with hazardous pathogens.
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The safety and immunogenicity of all vaccines used in the SIP should be studied carefully, as these data may have substantial value in a potential future national biodefense emergency. SOURCES OF NEW VACCINES FOR THE SPECIAL IMMUNIZATIONS PROGRAM Numerous vaccine candidates of potential value to the SIP either are under development in the United States or abroad or are already licensed for use in other countries.
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vaccine production and procure ment plans should be designed to take full advantage of the SIP program and to consider SIP vaccine needs. GOVERNANCE OF THE SPECIAL IMMUNIZATIONS PROGRAM The SIP appears to lack a governance structure that enables regular strategic review of the investigational and licensed vaccines included in the program and to lack mechanisms to address identified gaps in vaccines.
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Recommendation 8: All biodefense contracting and granting agencies should consider covering the cost of immunizing at-risk research work ers, so that this cost is not borne solely by the institutions working on government-supported programs. The committee supports the idea of central SIP administration but recommends that the SIP explore options for having a small number of satellite clinic locations around the country to reduce travel and inconvenience for other participating institutions (provided that they are able to adhere to the IND protocols)
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