personal and institutional liability (GAO, 2003). Some states chose to wait until these issues were resolved to begin vaccination, and many prospective volunteers expressed confusion about what protections were available to them and reluctance to assume risks without adequate assurance of protection (MacLeod, 2003; Roos, 2003a). In January 2003, the American College of Emergency Physicians (ACEP), the American Hospital Association (AHA), and the American Nurses Association (ANA), and others found that the narrow definition of liability coverage provided under Section 304 of the Homeland Security Act seemed to provide protection to the vaccine manufacturer, the vaccinator, and the institution operating a vaccination clinic but left other institutions and people without coverage (such as hospitals that do not have vaccination clinics although their personnel may receive vaccination elsewhere and vaccinated personnel in a noncovered institution who may be liable for inadvertently infecting a patient). Furthermore, ACEP, AHA, and ANA were concerned about an incomplete and confusing patchwork of compensation solutions (for example, worker compensation not applicable to volunteers and differences among states) and the lack of a no-fault compensation mechanism for volunteers who experience complications and for people inadvertently infected by vaccinees. Although some states and institutions provided coverage under worker compensation or other mechanisms, available coverage was fragmentary at best. The American Public Health Association, the American College of Occupational and Environmental Medicine, the Service Employees International Union (SEIU), the Association of Federal, State, County, and Municipal Employees, and many others called for the development of comprehensive compensation mechanisms to protect people injured by smallpox vaccination (APHA, 2002; SEIU, 2002; August, 2003; Russell, 2003). SEIU and other health professionals’ labor unions also called for a safer bifurcated needle (SEIU, 2002). The present committee urged CDC to clarify the status of compensation mechanisms as part of the informed consent process. As a result, CDC added information about compensation issues in the Vaccine Information Statement (Box 3-1).

On January 23, 2003, members of the Senate asked the White House to provide a plan for vaccine injury compensation (Daschle et al., 2003). Early proposals would provide coverage of vaccine injuries for those who would be vaccinated within 180 days of the program’s initiation; this created concern about inappropriate pressure to receive the vaccine (Meckler, 2003b). The comprehensive compensation plan was proposed by DHHS in early March 2003, 6 weeks after the expected start of the vaccination program. The Senate Committee on Health, Education, Labor, and Pensions passed the smallpox compensation bill on April 2, 2003, and the Smallpox Emergency Personnel Protection Act of 2003 (SEPPA, PL 108-20) was signed into law by President Bush on April 30, 2003. The SEPPA



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