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Preface Anthrax in its inhalational form is a deadly but very rare manifestation of infection with a common organism, Bacillus anthracis. Anthrax spores are very stable, a characteristic that makes possible their delivery as a weapon of biological warfare, and examples of weapons clevelopment efforts using anthrax are well known. It is important to protect the men and women in our armed services to the greatest extent possible. The Department of Defense (DoD) established the Anthrax Vaccine Immunization Program (AMP) in order to do so; however, some parties have raised questions about the safety and even the efficacy of the vaccine. As a result, the DoD is sponsoring an Institute of Medicine (IOM) stucly of the safety and efficacy of the vaccine, and Congress has instructed the Centers for Disease Control and Prevention (CDC) to conduct further safety and efficacy research. The CDC contracted! with the lOM to review their research program for completeness and appropriateness. This document is an interim report of the Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program, and reflects only a preliminary review of a program still in development. The CDC's anthrax vaccine safety and efficacy research program includes projects aimed at supporting an application to change the labeling of the licensecl anthrax vaccine, specifically to chance the route of administration from subcutaneous to intramuscular injection and to recluce the total number of doses. Based upon use of other vaccines and previous research, it is reasonable to expect that reduction in local and short-term systemic reactions to the presently available vaccine will be achieved by changing the route and schedule for inoculation. In addition, the CDC is also researching the acceptability of the anthrax vaccine, and so part of the research program involves assessing the knowledge, attitudes, and beliefs of vaccine recipients concerning the anthrax vaccine. While restricted by the statement of task to an evaluation of the CDC's anthrax vaccine safety and efficacy research program using the licensed vaccine, the committee cannot help but observe the substantial opportunity for development of a different and improved anthrax vaccine product. The science of vaccinology has ma(le great stricles in methods to enhance the purity, potency and consistency of vaccines. The committee members would welcome additional emphasis, from relevant federal agencies and/or industry, on research and development toward realizing the potential of contemporary vaccinology for a new anthrax vaccine product, free from impurities, that is, essentially a pure protective antigen vaccine. in, 1X