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Download e-book for kindle: An Assessment of the CDC Anthrax Vaccine Safety and Efficacy by Institute of Medicine, Medical Follow-Up Agency, Committee

By Institute of Medicine, Medical Follow-Up Agency, Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program

ISBN-10: 0309086264

ISBN-13: 9780309086264

ISBN-10: 0309503744

ISBN-13: 9780309503747

In 1998, the dept of safety (DoD) begun a software of needed immunization opposed to anthrax for all army body of workers. because the application proceeded, even if, a few army group of workers and their households raised issues concerning the defense and efficacy of the anthrax vaccine. Acknowledging either the necessity to guard army body of workers and the troubles concerning the anthrax vaccine, congress directed the facilities for sickness regulate and Prevention (CDC) to hold out a study application on its security and efficacy. to help 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 examine software. In An review of the CDC Anthrax Vaccine defense and Efficacy examine Program, the committee makes an total evaluate of the CDD study plan and experiences the categorical experiences proposed via CDC within the 3 parts of efficacy, safeguard and acceptability. The committee additionally notes extra study wishes that grew to become obvious following the bioterrorist occasions of 2001 and makes innovations concerning the management of the learn program.

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Extra info for An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

Example text

Military to administer AVA to 150,000 or more service members deployed for the Gulf War. S. service members with the licensed anthrax vaccine. , South Korea and Southwest Asia). By 2001, however, a limited supply of AVA had significantly slowed plans to vaccinate all military personnel. The limited supply of AVA was the result of an interruption in vaccine production. In 1998, Michigan Biological Products Institute (MBPI), the manufacturer of the anthrax vaccine, stopped production to renovate the vaccine manufacturing facility after receiving notification from the Food and Drug Admin istration (FDA) that corrective actions were needed to avoid revocation of the facility’s license (Zoon, 1997).

Recommendation: An external scientific advisory group should be constituted to provide guidance to CDC and DoD on all research undertaken through the VHC network. Given the draft study proposals reviewed by the committee, the advisory group should include, among others, experts in biostatistics (propensity analysis), health care outcomes assessment, pharmacoepidemiology (postmarketing surveillance), and clinical epidemiology (medically unexplained symptoms). Finding: The application of data mining and other statistical analysis techniques to screen data from VAERS and from DMSS data sets is still experimental.

Recommendation: CDC should design the focus groups and preliminary survey to take into account different racial and ethnic groups. Finding: As proposed, the survey of civilian and military health care providers has a focus on knowledge, attitudes, and beliefs concerning VAERS and vaccination with AVA. Additional questions oriented toward the development of educational materials concerning AVA and other vaccines, immunization, and adverse events could broaden its usefulness. In addition, further articulation of links between the study and development of educational materials is needed.

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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

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