Get 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

ISBN-10: 0309086264

ISBN-13: 9780309086264

ISBN-10: 0309503744

ISBN-13: 9780309503747

In 1998, the dept of safeguard (DoD) started a application of essential immunization opposed to anthrax for all army team of workers. because the application proceeded, notwithstanding, a few army group 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 body of workers and the worries concerning the anthrax vaccine, congress directed the facilities for affliction keep watch over and Prevention (CDC) to hold out a study software on its protection and efficacy. to aid within the improvement of this application, CDC asked the Institute of medication (IOM) to convene a committee to study the completeness and appropriateness of the study application. In An evaluate of the CDC Anthrax Vaccine safeguard and Efficacy study Program, the committee makes an total review of the CDD learn plan and stories the categorical reviews proposed via CDC within the 3 parts of efficacy, protection and acceptability. The committee additionally notes extra examine wishes that turned obvious following the bioterrorist occasions of 2001 and makes techniques in regards to the management of the examine program.

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

Sample text

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.

Thereafter booster doses were given at yearly intervals. This schedule was then used for the studies leading to licensure of AVA. , 2002). As described in detail elsewhere in this report, the Centers for Disease Control and Pre- 1 An adjuvant is a component that augments the immune response. Many vaccines require adjuvants for efficient elicitation of an immune response. 26 ASSESSMENT OF THE CDC ANTHRAX VACCINE RESEARCH PROGRAM vention (CDC) research plan includes a clinical trial to further evaluate the effect of these modifications on the safety and efficacy of the vaccine.

In Cha pter 4, the CDC research regarding the efficacy of AVA is described and the committee’s findings and recommendations regarding this aspect of the research plan are presented. Chapter 5 describes the CDC research that is to address the safety of the anthrax vaccine, followed by the committee’s discussion and evaluation. Chapter 6 reviews the research planned by CDC to address the acceptability of AVA and the committee’s findings and recommendations about this research. In Chapter 7, the committee discusses and evaluates the completeness and appropriateness of the research plan as a whole.

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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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