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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 protection (DoD) all started a software of needed immunization opposed to anthrax for all army team of workers. because the software proceeded, in spite of the fact that, a few army body of workers and their households raised matters concerning the security and efficacy of the anthrax vaccine. Acknowledging either the necessity to shield army group of workers and the worries in regards to the anthrax vaccine, congress directed the facilities for sickness keep watch over and Prevention (CDC) to hold out a examine software on its safeguard and efficacy. to help within the improvement of this software, CDC asked the Institute of medication (IOM) to convene a committee to check the completeness and appropriateness of the examine software. In An overview of the CDC Anthrax Vaccine defense and Efficacy examine Program, the committee makes an total overview of the CDD study plan and stories the categorical experiences proposed by way of CDC within the 3 parts of efficacy, defense and acceptability. The committee additionally notes extra learn wishes that turned obvious following the bioterrorist occasions of 2001 and makes innovations concerning the management of the learn program.

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

Example text

Several witnesses also reported conditions that they ascribed to receipt of AVA, including hypogonadism; Stevens-Johnson syndrome, which affected their vision as well as their skin; and a case of fatal aplastic anemia (Eberhart, 2001; Nietupski, 2001; Rugo, 2001). 28 ASSESSMENT OF THE CDC ANTHRAX VACCINE RESEARCH PROGRAM As noted in Chapter 1, the IOM’s Committee to Assess the Safety and Efficacy of the Anthrax Vaccine reviewed case reports and epidemiologic studies, both unpublished and published, and concluded from these data that AVA is reasonably safe, even though injection-site reactions such as redness, itching, swelling, and tenderness are fairly common (IOM, 2002).

This report is a review of plans by the Centers for Disease Control and Prevention (CDC) for a congressionally mandated research program on the safety and efficacy of the anthrax vaccine. As described below, the motivation for the CDC anthrax vaccine safety and efficacy research program was concerns about the vaccine among some military personnel and members of the public following the start of mandatory immunizations against anthrax for the military in 1998. However, the bioterrorist events of 2001 radically altered perspectives on the need for anthrax vaccine, making what had been a hypothetical risk—exposure to aerosolized anthrax spores—seem far more concrete.

Such efforts are being undertaken as part of the CDC research program. REGULATORY CONSIDERATIONS The pilot study carried out by Pittman and colleagues (2002) evaluated the immunogenicity and adverse event profile associated with a change from SQ to IM administration of AVA and with the use of fewer doses of AVA. The study indicated that the IM route of administration was associated with fewer injection-site reactions and was as immunogenic as SQ administration, as indicated by anti-PA IgG antibodies and toxin neutralization antibody (TNA) assay.

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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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