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).

Evaluation and Safety Studies

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

4  

Less than a week after the ACIP released its statement on the national smallpox vaccination program, the National Vaccine Advisory Committee (NVAC) issued a letter to the acting assistant secretary for health and director of the National Vaccine Program containing a resolution that was unanimously passed by the NVAC: “The National Vaccine Advisory Committee reaffirms the necessity for the nation’s health system to be prepared for biological threats, man-made or natural, and encourages continued efforts in this regard. With respect to the smallpox vaccination, the Committee recommends that the Assistant Secretary for Health in consultation with the Department’s Office of Public Health Emergency Preparedness consider the recommendations of ASTHO regarding the routine smallpox vaccination program and that further smallpox vaccinations, beyond those of public health response and vaccination teams, should be delayed until a national consensus is developed on appropriate next steps” (NVAC, 2003).



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