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APPENDIX Committee on Smallpox Vaccination Program Implementation SUMMARY OF RECOMMENDATIONS . _ . REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION'S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION Letter Report #2 OVERARCHING ISSUES: PREPAREDNESS AND EVALUATION A Focus on Preparedness The committee recommends that CDC work with states to decide what more is needec} to achieve smallpox preparedness, if anything. Further, given the routine turnover in personnel, each state should evaluate what it needs to maintain this preparedness. A Need for Evaluation The committee recommencis that CDC comprehensively evaluate the program and its outcomes in order to improve its implementation and to protect the vaccinees and the public. ~ . .. : - PROGRAMMATIC ISSUES Communication The committee recommencis CDC revisit and communicate to the public the program's objectives in view of state-level realities, and provide a preliminary perspective on the national ant! state success in reaching those objectives. The CDC should continue to support, as well as build on the experience of state ant! local health departments who are developing their communication strategies about state and local program implementation. The committee recommends that CDC and its state and local partners develop communications strategies that: I. Provide adequate quality ant! quantity of information. 2. Are timely. 3. Reassure the public that efforts are in progress to protect them in the event of a smallpox attack. 6 30
The committee recommencis CDC develop and offer journalists training materials and opportunities specifically (lesigne(1 for the media, explaining the program's clinical components, providing the best available scientific evidence, and dedicating staff experts to provide technical support to media representatives. Training and Education The committee recommends that all print materials addressed to a diverse audience (e.g., the public) should be easily read ant! understood by all members of that audience. Also, all communication materials in other languages should be culturally appropriate. The committee recommencis that eclucational 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 acIded to PVS to indicate which version of the Pre-Vaccination Information Packet was provident to the vaccines, 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). i The committee recommends that CDC work to ensure that a qualified health professional monitors, conducts a "take" reading, ant! provides a regular vaccination site inspection for each vaccinee in the program, ant! enters the relevant data into the appropriate smallpox vaccination program (lata system. .. . - The committee recommends that whenever the ACIP working group issues finclings/recommenciations to the ACTP 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 ant} maintaining the public's trust in the program. The committee recommencis 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. 6 31
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. The committee recommends that CDC work with DoD to decide how adverse events that involve both the civilian and military populations will be reported. Compensation The committee recommencis that CDC gather data on the reasons why potential vaccinees are clecTining vaccination, and document the extent to which lack of compensation is identified as a barrier, among other possible barriers (e.g., uncertainty surrounding risk of smallpox, fear of transmitting virus to contacts, extent to which local programs are encouraging vaccination). The committee recommends that the compensation language be easy to read and understandable to a wicle range of audiences. The committee recommencis that potential vaccinees be reminded of the current compensation situation before they formally give their consent to be vaccinated. Funding The committee recommends that this inquiry be broad in scope, and include not only cost to local and state health departments, but also the financial impact on the provision of other essential public health services, the costs incurred by participating hospitals, and estimates of costs of expanding the vaccination program to additional health care and public health workers, and emergency first responders. ~- 32
