Appendix F
Institute of Medicine: CDC Anthrax Vaccine Safety & Efficacy Research Program. Interim Report Findings and Recommendations1

FINDINGS

  • The CDC either has not developed, or has not communicated, a comprehensive plan for the CDC’s role in anthrax vaccine safety and efficacy research.

  • Despite the absence of a comprehensive plan, the CDC’s research program includes appropriate and well-conceived scientific projects that are generally responsive to the Congressional mandate.

  • The CDC’s research program also includes many particular projects that presently are quite underdeveloped or include unspecified elements.

  • Areas of potential collaboration between the CDC, DoD and NIH exist and should be more fully exploited, notably, for example the use of DoD databases such as the Defense Medical Surveillance System (DMSS).

  • The areas of potential deficit or concern can be remedied.

GENERAL RECOMMENDATIONS

  • The CDC should produce a comprehensive description of its research program, including statements of the goals of the program and how the plans now undertaken will meet those goals. In addition, the CDC should continue and complete development of the individual projects in the research program.

  • The CDC should consider engaging protocol design consultants representing broad scientific expertise who would provide immediate and direct consultation on specific technical matters of study design and execution.

  • The CDC should continue and strengthen collaboration with DoD and NIH wherever possible, including for example much more extensive use of DoD databases such as the Defense Medical Surveillance System (DMSS).

1  

These findings and recommendations appear in CDC Anthrax Vaccine Safety and Efficacy Research Program. Interim Report (Institute of Medicine, 2001; Washington, D.C.: National Academy Press). The complete report is available on the Internet at http://www.nap.edu/catalog/10157.html.



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Appendix F Institute of Medicine: CDC Anthrax Vaccine Safety & Efficacy Research Program. Interim Report Findings and Recommendations1 FINDINGS The CDC either has not developed, or has not communicated, a comprehensive plan for the CDC’s role in anthrax vaccine safety and efficacy research. Despite the absence of a comprehensive plan, the CDC’s research program includes appropriate and well-conceived scientific projects that are generally responsive to the Congressional mandate. The CDC’s research program also includes many particular projects that presently are quite underdeveloped or include unspecified elements. Areas of potential collaboration between the CDC, DoD and NIH exist and should be more fully exploited, notably, for example the use of DoD databases such as the Defense Medical Surveillance System (DMSS). The areas of potential deficit or concern can be remedied. GENERAL RECOMMENDATIONS The CDC should produce a comprehensive description of its research program, including statements of the goals of the program and how the plans now undertaken will meet those goals. In addition, the CDC should continue and complete development of the individual projects in the research program. The CDC should consider engaging protocol design consultants representing broad scientific expertise who would provide immediate and direct consultation on specific technical matters of study design and execution. The CDC should continue and strengthen collaboration with DoD and NIH wherever possible, including for example much more extensive use of DoD databases such as the Defense Medical Surveillance System (DMSS). 1   These findings and recommendations appear in CDC Anthrax Vaccine Safety and Efficacy Research Program. Interim Report (Institute of Medicine, 2001; Washington, D.C.: National Academy Press). The complete report is available on the Internet at http://www.nap.edu/catalog/10157.html.

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PROJECT-SPECIFIC RECOMMENDATIONS The committee recommends that, in the human clinical trial, the CDC should consider including a study group immunized at the start of the series (time zero), and one and six months later, followed by placebo, in order to assess adequacy of a simplified three-dose regimen in the development of immediate and long-term immunity to anthrax. The committee recommends careful selection of statistical methodologies, as certain techniques including intent-to-treat analysis may be less appropriate in developing conclusions for what will eventually be a military application than they would be for general civilian vaccine development. The committee recommends that the CDC consider, in addition to the proposed clinical trial, prospectively designed pharmacoepidemiologic study of military vaccine recipients with both active surveillance and historical data from DMSS for moderate and severe adverse events in order to assess sex or gender and perhaps other risk factors for adverse events among military personnel receiving the anthrax vaccine. The committee recommends that the CDC consider both the addition of a passive antibody transfer study, and that the animal trial dose ranging study design include a more gradual dilution series. The committee recommends that the use of microarrays receive further critical attention and precise evaluation of what information will be gleaned and how it will be interpreted and applied to anthrax vaccine recipients. The committee recommends that the CDC consider expanding the design phase of the KAB study of military personnel regarding the anthrax vaccine to include cognitive and psychometric tests and a pilot survey in order to design both the educational interventions and the survey that will relate to them, in order to refine the sampling plan. The committee recommends that the CDC consider expanding the design phase of the KAB study of military vaccine providers regarding VAERS reporting to include cognitive and psychometric tests and a pilot survey, in order to design both the educational interventions and the survey that will relate to them and possibly reduce the number of subjects. The committee recommends that the CDC consider including a study of the KAB of health care providers regarding the anthrax vaccine in the study now designed to assess only KAB on VAERS reporting. The committee recommends that the CDC make use of independent sources of information concerning vaccine adverse reactions in the military, such as the DMSS, when assessing any monitoring of, or modification to, VAERS reporting practices and VAERS analysis. The committee recommends that the CDC consider including additional items with the SF-36 specific to adverse events possibly associated with immunization, and clearly indicate how the use of the SF-36 will be included in the protocol.