receive the vaccine and never returned to the clinic for the second time), but it would at least provide detailed information on the reasons why some vaccinees decided against receiving the smallpox vaccine. Though not representative, these data could be used to inform revisions to educational materials for subsequent phases of the vaccination program. The carbon should only be included in the area of the page that collects data on the reasons for not receiving the vaccine and not in the area of the page that would include personally identifiable information. Potential vaccinees should be informed that completing the form is entirely voluntary, and should be told that this information will be used for contrast group purposes.

Should either of these methods be employed, the committee encourages CDC to pretest the survey and response materials in populations with different educational, socioeconomic, and cultural backgrounds.

Assessment of Safety Profile

CDC has obviously spent much time and effort in designing and planning for the comprehensive Smallpox Immunization Safety System (SISS). Ensuring that adverse reactions are identified, treated, quantified, and evaluated will be critical to the success of the pre-event smallpox vaccination program. The committee offers a few recommendations to help ensure that the SISS is as comprehensive, efficient, and effective as possible.

Early recognition, evaluation, and appropriate treatment of adverse reactions to the smallpox vaccine will be critical to limiting the adverse consequences of the smallpox vaccination program and to ensuring the public’s continued acceptance of the program. Detecting adverse reactions and evaluating them early will be the first step in this process.

The committee has had limited time to explore the interaction between CDC and the Food and Drug Administration (FDA), but hopes to turn to this important matter subsequently. CDC has capably assembled the necessary expertise to design the SSIS and the other components of the vaccination program. However, the committee believes that it is necessary to have the FDA fully engaged (to the extent which it is not already), and as quickly as possible, in all aspects of the program, and the SISS in particular. FDA involvement is important for ensuring that the requirements for the Investigational New Drug (IND) protocols for use of VIG and cidofovir are met. FDA’s involvement also is critical to ensuring that FDA’s surveillance systems become fully integrated into the overall surveillance for smallpox vaccine adverse reactions. CDC has been working extensively with FDA in determining how Vaccine Adverse Event Reporting System (VAERS) reports related to the smallpox vaccine will be shared with CDC and their



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