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1 Introduction
Pages 33-39

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From page 33...
... military to administer the licensed anthrax vaccine to an estimated 150,000 service members. After the war, admission by Iraq that it had indeed produced weapons containing anthrax spores confirmed fears of the potential use of anthrax as a biological weapon (Henderson, 1999; Zilinskas, 1997~.
From page 34...
... Congress called for the study to examine the safety and efficacy of the licensed vaccine, including consideration of the types and severities of adverse reactions, differences in reactions by sex, long-term health implications, its efficacy against inhalational exposure to all known anthrax strains, and correlation of the safety and efficacy of the vaccine in animal models to its safety and efficacy in humans. The study was also to address the issue of the validation of the manufacturing process, with consideration of discrepancies identified by the Food and Drug Administration in February 1998, definition of vaccine components, and identification of gaps in existing research.
From page 35...
... At the time of the legislation, the IOM Committee on Health Effects Associated with Exposures During the Gulf War was active in its work to evaluate the published scientific literature concerning the agents to which Gulf War veterans may have been exposed. Since the anthrax vaccine was among these exposures, the committee had already reviewed the available database
From page 36...
... IOM Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program In the 2000 Department of Health and Human Services appropriations legislation, Congress provided funding to the Centers for Disease Control and Prevention (CDC) for an effort to study the safety and efficacy of vaccines used against biological agents.
From page 37...
... anthracis aerosol production (CDC,2000~. ACIP did not recommend preexposure vaccination for emergency first responders, federal responders, medical practitioners, or private citizens for bioterrorism preparedness because "the target population for bioterrorist release of B
From page 38...
... Rather, the report focuses on the efficacy and safety of the current licensed vaccine and provides information for those who must establish vaccination policy. ORGANIZATION OF THE REPORT The varied components of the committee's statement of task (see Appendix A)
From page 39...
... The establishment of efficacy is crucial before one can consider the use of any such intervention, and no safety risk is tolerable in the absence of efficacy. Chapter 4 introduces the types of information available concerning the assessment of vaccine safety, whereas Chapters 5 and 6 review the safety data available on this vaccine from case reports and from epidemiologic studies, respectively.


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