events, as well as a sample of those vaccinees that experienced mild, less severe adverse events. This is particularly relevant now that two cases of dilated cardiomyopathy have been identified three months after vaccination (CDC, 2003n). (The DoD is planning on using the Millennium Cohort Study and the Defense Medical Surveillance System to compare and contrast people who have received the smallpox vaccine to people who have not received the vaccine [personal communication, J. Grabenstein, June 15, 2003].) Plans also should be made to assemble enough information so that follow-up can be done easily in the future.

  • Follow-up also would be valuable for the pregnancies inadvertently and intentionally (i.e., in response to contact with a case of monkeypox) exposed to smallpox vaccination. The committee notes that DoD has an ongoing birth defects registry (covering all dependants of military personnel) that could contribute information on any concerns that might arise.

The committee also suggests that CDC and the ACIP consider holding periodic invitational workshops on the science of smallpox vaccine safety and efficacy to update and disseminate new findings in these areas. The results of these workshops could be actively disseminated to CDC’s state and local partners in the smallpox vaccination program to update them on the latest research.

The committee encourages CDC to think long-term about the research agenda for the smallpox vaccination program. CDC has stated that the pre-event smallpox vaccination program will be an ongoing program (CDC, 2003i; CDC, 2003m), specifically in terms of vaccinating new people for maintenance of response teams, and broadly in terms of planning for a smallpox response. There will be many policy and implementation questions that will have to be answered along the way. The committee recommends that CDC begin developing a structured, prioritized research agenda that can aid decision-making as the smallpox preparedness program moves forward. The committee offers its assistance in refining this research agenda as the program evolves. Considering the extent of evaluation and research efforts that CDC could propose for the smallpox vaccination program as it moves forward, and the limited resources available to support all needed evaluation efforts, the committee encourages CDC to consider requesting the use of Public Health Service 1 Percent Evaluation funds for this purpose (if this approach has not been pursued already).5


The Department of Health and Human Services is authorized under the Public Health Service Act to set aside up to one percent of appropriations for Public Health Service (PHS) programs for evaluation (directly, or by grants of contracts) of the implementation and effectiveness of PHS programs (42 USC 238(j)).

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