Institute of Medicine, Medical Follow-Up Agency, Committee's An Assessment of the CDC Anthrax Vaccine Safety and Efficacy PDF
By Institute of Medicine, Medical Follow-Up Agency, Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program
In 1998, the dept of protection (DoD) begun a application of vital immunization opposed to anthrax for all army group of workers. because the application proceeded, although, a few army team of workers and their households raised matters in regards to the protection and efficacy of the anthrax vaccine. Acknowledging either the necessity to shield army team of workers and the worries concerning the anthrax vaccine, congress directed the facilities for disorder regulate and Prevention (CDC) to hold out a examine software on its defense and efficacy. to aid within the improvement of this application, CDC asked the Institute of drugs (IOM) to convene a committee to check the completeness and appropriateness of the learn software. In An evaluation of the CDC Anthrax Vaccine defense and Efficacy learn Program, the committee makes an total overview of the CDD study plan and experiences the explicit reports proposed via CDC within the 3 parts of efficacy, defense and acceptability. The committee additionally notes extra examine wishes that turned glaring following the bioterrorist occasions of 2001 and makes thoughts concerning the management of the examine program.
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Extra info for An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program
Joellenbeck LM, Zwanziger LL, Durch JS, Strom BL, eds. The Anthrax Vaccine: Is It Safe? Does It Work? : National Academy Press. Pittman PR, Kim-Ahn G, Pifat DY, Coonan K, Gibbs P, Little S, Pace-Templeton JG, Myers R, Parker GW, Friedlander AM. 2002. Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans. Vaccine 20(9–10):1412–1420. 1 Introduction Anthrax is a disease caused by Bacillus anthracis, a spore-forming bacterium whose characteristics of stability and availability make it a feasible choice for biological warfare.
Recommendation: As part of its research plan, CDC should support studies in laboratory animals to establish an appropriate duration for antibiotic prophylaxis when administered with AVA following B. anthracis spore challenge. Finding: The exposure of members of the civilian population to anthrax spores in the bioterrorist incidents in the fall of 2001 demonstrates the importance of determining the immunogenicity and reactogenicity of AVA or any future anthrax vaccine when used by children, the elderly, and persons with chronic illnesses.
The document describing the research plan and the accompanying study protocols that CDC provided in response to the IOM request received significant emphasis in the committee’s evaluation of the research plan, supplemented by information gathered and discussed in the committee meetings. A subset of these documents is provided in Appendix C. The original timeline for the IOM review of the CDC research plan called for an interim report to be delivered by June 30, 2001, and a final report by the end of the original task order period (August 2002).
An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program by Institute of Medicine, Medical Follow-Up Agency, Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program