to describe both the common (i.e., local and systemic reactions) and serious adverse reactions (e.g., generalized vaccinia, serious cases of accidental inoculation, eczema vaccinatum, progressive vaccinia, vaccinia keratitis, and encephalitis). There may be some suspected adverse reactions that are not yet recognized as being causally associated with the vaccine. If these suspected adverse reactions are determined to be causally associated with the smallpox vaccine, then compensation should address these reactions as well.] It does so because it believes that the currently stated plans for compensation for adverse reactions could seriously affect achievement of the stated goal of the program—to increase the nation’s bioterrorism preparedness. A number of hospitals have said that they will not participate in the pre-event vaccination program until these issues are resolved (McKenna, 2002; Price, 2002). The committee believes that resolution of the adverse reaction compensation issues is important for the informed consent process, clearly a part of the committee’s charge. Concerns about lifelong disability resulting from the vaccine (particularly neurological disability from postvaccinal encephalitis) also may arise, and the committee encourages consideration of how to address disability issues. Implications of the pre-event vaccination program for issues related to health insurance, disability insurance, and life insurance also should be considered.

The committee notes that the Homeland Security Act of 2002 (Public Law No. 107-296) provides a federal mechanism to compensate vaccinees who are injured due to negligent manufacture or administration of the smallpox vaccine (but does not cover adverse reactions that occur despite non-negligent manufacture and administration). This has encouraged manufacturers and vaccine administration sites to participate in the pre-event vaccination program, as it reduces their liability exposure for adverse reactions. The Homeland Security Act does not, however, provide reimbursement to vaccinees for costs associated with participating in the program when there are no instances of negligence. These costs may include administrative leave (with possible loss of salary) in order to avoid accidental infection of vulnerable patients in their workplace; lost income due to time away from work while recuperating from adverse reactions that occur despite non-negligent manufacture and administration of the vaccine, particularly for nonsalaried workers; and unreimbursed medical expenses associated with treating adverse reactions that occur despite non-negligent manufacture and administration of the vaccine. In addition, the committee notes with concern that there may be some people, such as patients and family members, who are infected accidentally by contact with a vaccinee, despite efforts to care for the vaccination site appropriately. Recognizing this, contacts should be considered part of the population that is vulnerable to adverse reactions and, thus, losses from the vaccine. This is not unlike the policy of vaccine-associated paralytic polio



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