smallpox vaccination that occurs should be carried out only within the context of the currently recommended response teams and state and local response plans and should be administered according to currently recommended vaccination procedures and protocols” (ACIP, 2003).⁴ In their statement, the ACIP also reiterated “that it is critical for smallpox preparedness planning, within the context of broader terrorism and emergency response planning, to continue at the federal, state and local levels” (ACIP, 2003).

The committee appreciated receiving the updated “Smallpox Vaccination Program Plans for Phase 1 Evaluation and Research” (CDC, 2003g) and found it very helpful to see all of the ongoing and planned evaluation and research activities in one document.

As CDC has acknowledged, evaluation of the cardiac adverse events reported following smallpox vaccination is very important to safely continue the smallpox vaccination program. CDC has been consulting with multiple experts in the field of cardiology and chronic disease epidemiology to investigate both the ischemic adverse events and the myo/pericarditis cases. To evaluate the cardiac adverse events, CDC’s investigations have included: CDC-assisted epidemiologic field investigations (“epi-aids”) in the states where deaths have occurred to obtain more comprehensive information on the cases; evaluation of case series data; collection of data on expected rates of cardiac events in comparable unvaccinated populations; and potential prospective studies that could provide information on biologic plausibility and rates of these events (CDC, 2003g).

Both CDC and the working group described considering the utility of animal studies that would investigate the basic pathophysiology of cardiac disease in relation to smallpox vaccination. CDC has stated that “studies to evaluate possible biologic mechanisms for cardiac adverse events following