Fears that terrorists may have the capabilities and intent to disseminate a variety of biologic agents has once again brought smallpox into the American consciousness. On December 13, 2002, recognizing that the global discontinuation of routine smallpox vaccination over two decades ago had left most Americans unprotected and vulnerable to the ravaging affects of the virus, the President announced a precautionary measure to begin vaccinating teams of emergency responders. The program commenced January 24, 2003. In the ensuing months, public health departments scrambled to meet the goal of vaccinating approximately 500,000 first responders, a protected phalanx that could quickly and effectively contain a smallpox outbreak by tracking and vaccinating exposed individuals and their close contacts. However, a formidable obstacle to achieving this goal arose, because the smallpox vaccine had a known range of mild to serious (sometimes life-threatening) side effects. By January 31, 2004, only 39,353 civilian first responders, fewer than 10 percent of the targeted individuals, had received smallpox vaccinations. In this Article, which is based on formal survey results, the authors review the fiscal, logistical, and legal obstacles that prevented the program from gaining momentum and achieving its initial goals. Public health agencies, already strapped for resources, had to re-direct their efforts from routine responsibilities while also working to fulfill the general bioterrorism preparedness benchmarks set forth in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Smallpox vaccination programs proved to be no small diversion. Sufficient federal funds were not made available to support what was clearly a federal interest, which often forced public health agencies to "borrow against" state public health budgets. Uncertainty over legal liability on the part of those administering the smallpox vaccine and the ability of those potentially injured by the vaccine to obtain financial recovery were by far the principal reasons articulated by study participants for their reluctance to participate in the vaccination effort. Shortly before the commencement of the smallpox vaccination program, Congress enacted legislation to provide liability coverage for, among other parties, those administering or manufacturing the vaccine, but it was ambiguous, and it left important players in the public health and health care communities exposed to liability from participation in the vaccination program. Moreover, the scheme designed to reimburse vaccinees for injuries resulting from the vaccine made recovery of damages exceedingly difficult. HHS Secretary Thompson on January 28, 2003 attempted to provide an administrative remedy, but his legal authority to do so was widely questioned. It was not until three months after the first smallpox inoculation under the program was administered that Congress passed further remedial liability and compensation legislation. While an improvement over its initial effort, this belated legislative effort wholly failed to reinvigorate what was, by that time, the faltering vaccination program. While the failings of the civilian smallpox vaccination program are important to acknowledge in and of themselves, the more pervasive issue in this climate of terrorist threats and capabilities must be, however, whether or not the "lessons learned" from the Phase I Smallpox Vaccination Program will facilitate more proficient and effective bioterrorism preparedness efforts moving forward.
2004 Journal of Homeland Security (2004).