sation program’s position on coverage for smallpox vaccine–related injuries and illnesses for workers covered under their programs.

The committee recommends that CDC and the Department of Health and Human Services support all efforts, some of which might be administratively or legislatively bold and creative, to bring this issue of compensation for smallpox vaccine adverse reactions—including those reactions that occur despite non-negligent manufacture and administration of the vaccine—to speedy resolution.

Workforce Issues Resulting from Vaccination

The committee recommends that during phase I, CDC assess the effects of the current situation regarding administrative leave, disseminate the analysis widely, and before phase II begins, decide whether the ACIP recommendation needs to be reassessed. Any evidence of transmission of vaccinia virus to a patient from an immunized health care worker should lead to an active case investigation or to an immediate reassessment of policy.

Opportunity Costs

The committee recommends that CDC work with their public health partners to document as well as possible the true costs of the smallpox program.

Informed Consent Process

The committee recommends that all consent documents include a statement that the risks of the smallpox vaccine, while very low, are predictably higher than the risks associated with most other vaccines, but that the benefit is presently unknown—possibly very low (absent exposure to smallpox) or very high (in the event of exposure).

The committee further recommends that informed consent forms include explicit notification of the availability, or lack thereof, of compensation for adverse reactions.

Comprehension of Screening Materials

Understanding that different populations may interpret the educational and screening materials somewhat differently, the committee recommends that CDC pretest the educational and screening materials in populations with different educational, socioeconomic, and cultural backgrounds before these materials are used for the first phase of the pre-event smallpox



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