The Homeland Security Act provides general protections for persons and institutions assisting the government during a bioterrorism incident and specific protections for smallpox vaccination programs. Section 304 of the Act went into effect on January 24, 2003, but the Secretary of HHS must make a "declaration" that smallpox poses a potential public health emergency risk requiring vaccination as a countermeasure. Until such a declaration is made, the Act provides for no protection for persons involved in providing countermeasures. There are significant concerns regarding liability issues involved with a smallpox vaccination program due to the incidence of vaccine-related complications, including several issues that require additional legal clarification concerning who and under what circumstances the immunity attaches.
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