The committee recommends that educational and training materials be tested for ease of comprehension with samples representing a cross-section of the sex, race, ethnicity, and level of education.

Data to Assess Vaccine and Program Safety

The committee recommends that a data field be added to PVS to indicate which version of the Pre-Vaccination Information Packet was provided to the vaccinee, in order to document what information was given to the vaccinee prior to consent.

The committee recommends that CDC consider adding a data field to HSVMS to indicate whether a serious adverse event occurred or whether a VAERS report was filed (understanding that more complete information about circumstances surrounding the adverse event will be entered into VAERS and the Active Surveillance System).

The committee recommends that CDC work to ensure that a qualified health professional monitors, conducts a “take” reading, and provides a regular vaccination site inspection for each vaccinee in the program and enters the relevant data into the appropriate smallpox vaccination program data system.

The committee recommends that whenever the ACIP working group issues findings/recommendations to the ACIP and through it to the director of CDC, it carefully consider concurrent release to the public and do so if it would be in the interest of transparency and maintaining the public’s trust in the program.

The committee recommends that CDC be very clear about what types of adverse events will be reported to the public and when.

The committee recommends that the vaccination report webpage use categories that correspond to the categories presented in the MMWR adverse event reports.

The committee recommends that CDC report on a regular basis how effective screening practices have been at identifying contraindications (e.g., pregnancy, HIV status, eczema or atopic dermatitis) prior to vaccination.

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