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

In 1998, the dep. of safety (DoD) started a application of necessary immunization opposed to anthrax for all army group of workers. because the software proceeded, in spite of the fact that, a few army team of workers and their households raised issues in regards to the security 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 ailment regulate and Prevention (CDC) to hold out a learn software on its security and efficacy. to aid within the improvement of this application, CDC asked the Institute of medication (IOM) to convene a committee to check the completeness and appropriateness of the learn software. In An overview of the CDC Anthrax Vaccine safeguard and Efficacy learn Program, the committee makes an total overview of the CDD examine plan and reports the explicit experiences proposed by means of CDC within the 3 components of efficacy, security and acceptability. The committee additionally notes extra learn wishes that grew to become obvious following the bioterrorist occasions of 2001 and makes innovations concerning the management of the study program.

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

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Regarding the anthrax study, the conferees understand that clinical studies will be greatly facilitated by the establishment of the Vaccine Healthcare Center Network, with the first site at Walter Reed Army Medical Center. ” BOX 1-2 Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program Statement of Task This committee will advise the Centers for Disease Control and Prevention (CDC) on the completeness and appropriateness of the CDC plan to respond to the Congressional mandate to study the safety and efficacy of anthrax vaccine, addressing: (1) risk factors for adverse reactions, including gender differences; (2) determining immunologic correlates of protection and documenting vaccine efficacy; (3) optimizing the vaccination schedule and routes of administration to assure efficacy while minimizing the number of doses required and the occurrence of adverse events.

Military, in December 1997 DoD announced a program to vaccinate all service personnel against anthrax using the li- 18 INTRODUCTION 19 censed product AVA. The vaccination plan was to be phased in gradually, starting with service members judged most likely to encounter the threat. The first vaccinations under DoD’s Anthrax Vaccine Immunization Program (AVIP) took place in March 1998. As more members of the military received the mandatory vaccine doses, some raised concerns about the safety and efficacy of the vaccine being administered.

L. No. 99-660 (1986). BACKGROUND 29 and investigation. However, VAERS also has certain critical limitations (Chen, 2000; Ellenberg and Chen, 1997; IOM, 1994a,b). Adverse events that occur soon after a vaccination may be reported to VAERS whether or not they are causally related to the vaccination. 4 Duplicate reports of the same case may be submitted. The medical information provided on the form may be incorrect or incomplete. , multiple exposures and multiple outcomes) also makes analysis difficult.

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