likely to remove one of the barriers to vaccination identified by the committee and others (APHA, ASTHO, and NACCHO, 2003).2 As this is a complex matter, the committee notes the need for additional clarification by CDC to the states on the provisions of the law and for fact sheets or other explanatory materials for potential vaccinees. These fact sheets should clearly explain the provisions of the legislation and protections enacted and refer potential vaccinees to additional information sources, such as their own state health department.

CONSIDERATIONS FOR NEXT STEPS IN THE VACCINATION PROGRAM

It is imperative that before continuing to expose individuals to a vaccine that is effective, but not without some risks, the national and state programs determine what level of pre-event vaccination is needed for preparedness. In its first report (IOM, 2003a), the committee recommended that “sufficient time should be allowed between the two phases to ensure adequate assessment and plan revision by CDC and its partners” and in its second report (IOM, 2003b), it recommended that the evaluation of “the effectiveness of implementation and the safe use of the vaccine” be carried out as extensively as allowed by “the mandates and realities of the vaccination program.” At the program’s beginning, it appeared that a wide variety of data about the process and the outcomes of the first phase of vaccination would be available and that comprehensive evaluation could be conducted between phases. Although the initially expected civilian numbers have not been reached, pausing to evaluate remains an important component of the overall program of safely building smallpox preparedness. Also, by combining the safety data from both civilian and military vaccinations (totaling over 460,000 vaccinees) a great deal can be learned, shared, and disseminated (CDC, 2003a; DoD, 2003). CDC acknowledges that there is “a natural pause that occurs between stage one and stage two” (Henderson, 2003).

The committee recognizes that pausing also involves potential risks. A pause implies slower vaccination of the number of responders a jurisdiction may require for preparedness, a loss of momentum, and perhaps vulnerability in the event of a potential smallpox event. However, given that the smallpox threat level, as it is publicly described, has not changed, the committee continues to believe that the benefits of the pause likely out-

2  

At the time of the writing of this report, the compensation language in CDC’s Vaccine Information Statement had not yet been updated to reflect the newly enacted legislation.



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