timely fashion. Also, if there were inadvertent inoculation of civilian contacts of military vaccinees, it was not immediately clear which program—the civilian or the military—would include these cases in its adverse events surveillance.

Studies of reported adverse events (such as myocardial infarctions and myo/pericarditis) (CDC, 2003b) benefited from having the larger combined civilian and military vaccinees as potential study populations. For example, the data from the military supported the finding in the civilian population that cases of myo/pericarditis were associated with smallpox vaccination. However, it was also more difficult to identify adverse events specifically caused by the smallpox vaccine in the military population, because members of the military often received multiple concurrent vaccinations.

DoD has also made some important findings in its smallpox vaccination program. For example, in November 2003, two independent panels examined four deaths potentially related to DoD’s vaccination program and found that one (the April 2003 death of a 22-year-old reservist) may have been triggered by several vaccinations she received, including smallpox vaccine (DoD, 2003, 2004a). In February 2004, DoD reported that an infant contracted tertiary vaccinia infection from breastfeeding (the mother was inadvertently inoculated by the father) (CDC, 2004e). In the August 25, 2004, Smallpox Vaccination Program Safety Summary, DoD reported that over 631,000 personnel had been vaccinated and that most adverse events had occurred at a rate lower than historical rates (DoD, 2004c).

Despite some early challenges, the collaboration between CDC and DoD gave the ACIP Working Group on Smallpox Vaccine Safety access to the substantial amount of data gathered by the much larger military program. The committee has previously expressed its hope that the Department of Defense Serum Repository and the Millennium Cohort Study will serve as resources for CDC as it follows up vaccinees and learns about the long-term sequelae of serious adverse events (IOM, 2003d).

PROGRAM CHALLENGES

A Push for Rapid Implementation Without Adequate Preparation

The committee has found that owing to the initial emphasis on rapid implementation of the smallpox vaccination program, CDC had little or no time to finalize or test many of the program components (such as the completeness or consistency of vaccine information and education materials) or to address identified barriers to implementation (IOM, 2003a, or refer to Appendix B in this report). That may explain many of the problems with the execution of the program, such as the financial and opportunity-



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