In its first report (IOM, 2003:5), the committee observed that generally, “public health interventions are undertaken with recognition of some benefit to some individuals, no effect on others, and the possibility of some risk to a small percentage of the population …, with expectation of overall benefit to the population receiving the intervention.” The committee believes it is important to reiterate the risk-benefit context of the smallpox vaccination program.

“Based on the administration’s statement¹ that the risk of a smallpox attack is indeterminate (not zero but currently assumed to be very low) (White House, 2002), the benefit of the vaccination program to the public also is not zero but is assumed to be very low. The benefit to any individual might indeed be zero if the individual never encounters the smallpox virus. However, in the event of exposure to smallpox virus, the benefit to individuals may be very high. Given this profile of high vaccination risk and likely very low to zero benefit, the administration’s policy to offer vaccination to public health, medical, and emergency workers must be implemented in a most prudent and cautious manner.”

Understanding this complex reality highlights the importance of both preparedness to ensure optimal benefit to the public (i.e., rapid vaccination in the event of smallpox attack) and evaluation to ensure the lowest risk from the vaccine (i.e., overall program safety, including safe use of the vaccine).

The expressed intent of the expansion, as the committee understands it, is to make the vaccine available to greater numbers of relevant personnel. However, it is important to retain a focus on smallpox preparedness as the goal of the program. Increasing the number of vaccinated persons might contribute to meeting that goal, but it does not mean preparedness to respond to a smallpox attack has been achieved. Having more vaccinated individuals is only as effective as the plans for deploying these individuals in a potential smallpox bioterrorist event and the collaboration and communication among the various agencies responsible for aspects of smallpox preparedness. This means that a jurisdiction needs not only sufficient workers to vaccinate the public, diagnose and treat cases, and conduct other needed activities (e.g., identify and protect immediate contacts), but also well-