CDC’s stated objectives for the safety component of its anthrax vaccine research program are displayed in Box 5-1. At the request of the committee, CDC also identified a set of critical research questions, shown in Box 5-2.

BOX 5-1 CDC Objectives for Research on the Safety of the Anthrax Vaccine

  • To investigate potential long-term sequelae of AVA.

  • To gain a better understanding about the type, frequency, and gender differences of vaccine adverse events associated with AVA.

  • To evaluate the completeness and accuracy of reporting of AVA adverse events in the military and to develop and implement interventions to improve AVA adverse events reporting and surveillance.

  • To assess AVA administration practices and the military immunization health care system that may impact AVA adverse events, and to enhance AVA delivery practices (quality assurance of AVA administration services in the military).

  • To evaluate concerns that military personnel may have about AVA and improve their knowledge and understanding about the risk benefit of AVA and other vaccines.

  • To provide AVA information, education, and communication resources to the civilian public and to military personnel in collaboration with the Department of Defense.

SOURCE: CDC, 2002d, p. 11.

BOX 5-2 Critical Research Questions Regarding the Safety of the Anthrax Vaccine, as Identified by CDC

  • How does changing the route of administration affect the safety profile of AVA?

  • What are the important risk factors for the development of adverse events to AVA?

  • Is gender an important risk factor for the development of adverse events to AVA?

  • What is the overall safety profile of AVA immunization?

  • Are there any chronic health or long-term problems associated with AVA immunizations?

  • Are there specific syndromes or disorders associated with AVA?

  • Does hormonal phase affect the occurrence of adverse events [in women]?

  • Is AVA safe for children?

  • Is AVA safe for use in the elderly?

  • Is AVA safe for women, with respect to reproductive health?

  • What is the safety profile of AVA when administered postexposure with antibiotics?

  • What is provider knowledge of VAERS and compliance with reporting to VAERS?

SOURCE: CDC, 2002e.

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