mune suppression, contact transmission). The committee endorses the general approach that the working group is taking for all of these actions. The working group has developed detailed plans for assessing different disease endpoints. However, understanding that the committee has not been privy to all of the working group’s discussions, the committee would like to obtain more information about the working group’s deliberations about death as an endpoint (as compared to the disease endpoints that are being considered).

The working group noted in the summary of the March 20-21, 2003, meeting that they still needed to define a trigger point for further action with regard to inadvertent vaccination of HIV infected persons. The committee looks forward to seeing the working group’s definition of this trigger point when it is finalized.

The committee also endorses the working group’s proposal for animal studies that investigate the basic pathophysiology of cardiac disease in relation to smallpox vaccination and the proposal to systematically observe and record how vaccine sites are managed and what outcomes result (ACIP SVS WG, 2003a).

As the working group has followed the safety data from the civilian and military smallpox vaccination programs, they have paid increased attention to the myo/pericarditis cases reported in both programs. In evaluating both the inflammatory (i.e., myo/pericarditis) and ischemic (e.g., myocardial infarction, angina) cardiac events, the working group was asked to evaluate a number of questions related to these events. Specific to the myo/pericarditis cases, the working group was asked, “Does a causal relationship exist between vaccination and inflammatory heart disease?” (Neff, 2003). The working group concluded, “DoD data support a risk for myocarditis after smallpox vaccination that is significantly higher than background rate, and suggest that a causal association is highly likely” (Neff, 2003).

This conclusion was one of the primary reasons that the majority (10 of 12) of the working group recommended that CDC “[c]ontinue with the current pre-event volunteer program, to vaccinate and maintain vaccination status of selected public health and first response health care workers with careful screening for known risk factors with a goal of meeting and maintaining state and local health department readiness needs,” in addition to the entire working group recommending, “No member favors beginning phase 2 of the vaccination program” (Neff, 2003). After being presented with these recommendations of the working group, the full ACIP unanimously approved a draft resolution and later released a final statement recommending to CDC that it would be “unwise to expand beyond its current, pre-event smallpox vaccination recommendations because of the new and unanticipated safety concerns, i.e., myo/pericarditis, whose extent and severity, particularly of long term sequelae, are not yet known. Any

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