In the Bush administration, pharmaceutical protection became the centerpiece of biodefense policy. On December 13, 2002, convinced of the Dark Winter-type threat of smallpox, President Bush announced his nationwide smallpox inoculation program. Publicity about Iraq's potential biological arsenal, especially in the lead-up to the 2003 invasion, and the threat of bioterrorism had convinced many in the public to participate. The states and the CDC were ready to handle the logistics. In addition, civilian participation was voluntary, which reduced legal liability for those who administered the vaccine and for the government. As might have been predicted, this smallpox vaccination campaign found it difficult to circumvent the well-known fears of vaccination as a source of bodily pollution and the mistrust engendered when vaccines appear a worse health risk than the forecast epidemic. The swine flu vaccination program during President Gerald Ford's administration was a controversial miscalculation that killed two dozen and sickened hundreds and, because the flu never struck, it caused widespread distrust in government health initiatives (Tanielian, et al. 2005). Reliance on intelligence calculations can be a necessary but problematic basis for predicting epidemics, even for the military.

The Pentagon's universal anthrax vaccine program in the 1990S resulted in dishonorable discharge for more than four hundred soldiers who refused to be vaccinated and it caused dozens of National Guard pilots to resign, out of fear of serious, unpredicted side effects that appeared worse than any biological weapons threat. ' The first phase of the smallpox campaign was the mandatory vaccination of 500,000 military and government employees who might be deployed to the Middle East or other potentially high-risk areas.

Starting January 2003, Phase One also included the voluntary vaccination of 500,000 ?front-line? civilian health workers and first responders on specialized ?Smallpox Response Teams. In the second phase of the smallpox vaccination program, in March- April 2003, ten million additional healthcare workers and first responders could opt to be vaccinated. In the fall of 2003, in Stage Three the vaccine would become available to the American public at large. (Phases Four and Five were emergency strategies for containment in the event of a smallpox outbreak, which meant quarantine and mass vaccination.) Unlike the anthrax vaccine, the most available U.S. smallpox vaccine, called Dryvax, had a well-known history' (Neergaard, 2011). Administered with a bifurcated needle, it took six to eight days to be effective. If given within four days of exposure, the vaccine might significantly reduce the chances of sickness and death.

The typical reactions to the smallpox vaccine ranged from soreness at the vaccination site to headaches, swelling of the lymph nodes, and fatigue. Brain swelling (en- cephalitis) was a known but rare reaction. The death rate estimated for universal smallpox vaccination could theoretically be as high as one percent: if ten million people were vaccinated, some ten thousand might die, unless risk factors were recognized in advance. The vaccine was contraindicated for those with eczema or other skin diseases, for pregnant women, and for those whose immune systems were compromised or who were taking immune-suppressing medication.

Conclusion

As the RAND Report identified: "With the continuation of the funding for public health preparedness, it is anticipated that state and local public health departments will continue to develop new practices and refine existing ones, in an effort to meet the critical benchmarks and capacities...

We recommend that DHHS continue to review and evaluate these efforts as a means of updating this repository over time and maintaining relevance with the evolving needs of public health departments." Identifying these risk factors posed problems. For example, the CDC estimated that around 300,000 Americans were unknowingly HIV-infected. The smallpox vaccination guidelines suggested HIV testing but did not insist on this precaution. In addition, after the shot, the vaccine site could shed virus cells and cause illness (called ?contact vaccinia?) that could be dangerous to others. Throughout 2003, just a few reported adverse reactions to the smallpox vaccine caused a drop in public participation. Unexpected heart symptoms (cardiac adverse events) were particularly alarming.'3 Among the 250,000 soldiers vaccinated for the first time by March 31, fourteen (ranging in ages from twenty-one to thirty-three) suffered heart problems, either myocarditis or pericarditis or both. The 100,000 other soldiers being revaccinated reported no such problems with inflammation. Overall, the military was positive about the smallpox vaccine program. By late March 2003, just under thirty thousand civilians had been vaccinated nationally, a small fraction of those expected to cooperate.
Three of these volunteers had heart attacks, two of them fatal, and seven others suffered other heart-related problems. The CDC characterized the three first responders (ages fifty-five to sixty-four) who suffered heart attacks as already having clearly de- fined risk factors, such as high cholesterol levels, cigarette smoking, and a previous history of heart trouble. The same appeared true for a fifty-five-year-old member of the National Guard who died of a heart attack five days after being vaccinated. The distinction between the vaccine's causing heart failure and its contributing to heart failure was lost on many.

The threat of terrorists attacking with smallpox aerosol seemed more remote than these reported illnesses and deaths, especially as the Iraq war was declared over in May and the threat of bioterrorism faded from the news. Fifteen states immediately halted their vaccination programs. Many hospitals independently withdrew participation. The federal government stayed committed to the program, although the intelligence data supporting this commitment, always vague, remained un- specific. In July 2003, the CDC was given $100 million to dispense to states to improve participation rates. The Johns Hopkins physicians who had organized the Dark Winter scenario remained optimistic about the smallpox campaign as a way to reduce the risks of bioterrorism.

References

Fauci, Anthony S.M.D., Bioterrorism Preparedness: NIH Smallpox Research Efforts, available at http://www.hhs.gov/asl/testify/t011102b.htm Accessed on October 22, 2011.

Frist, William. The Political Perspective of the Bioterrorism Threat, in Biological Threats and Terrorism: Assessing the Science and Response Capabilities, 29 (Stacy L. Knobler & Adel A.F. Mahmoud & Leslie A. Pray eds., National Academy Press 2002).

Neergaard, Lauran. Postmaster: Anthrax Threatens Mail, The Washington Post, Oct. 24, 2001, available at http://www.washingtonpost.com/wp-srv/aponline/20011024 / aponline090115_002.html Accessed on October 21, 2011.

Tanielian, Terri. Ricci, Karen. Stoto, Michael A. David Dausey, J. Lois M. Davis, Myers, Sarah. Olmsted, Stuart. Willis, Henry H. (2005) Exemplary Practices in Public Health Preparedness. RAND Corporation. http://www.rand.org/content/dam/rand/pubs/technical_reports/2005/RAND_TR239.pdf Accessed on October 21, 2011.