CDC has asked for the committee’s assistance in prioritizing research and evaluation efforts specific to the smallpox vaccination program, given the limited resources available for these activities (personal communication, B. Gellin, CDC, March 26, 2003). The committee recommends that in the short term, studies of the serious adverse events should receive the highest priority. For safety-related questions, in the longer term, studies examining long-term outcomes for those who experienced both serious and mild adverse events and studies of how mild adverse events contributed to lost work or social function should be a high priority. For system-related questions, in the longer term, studies of cost and opportunity costs should be a high priority. The committee believes that, although still important, studies on the reasons why people declined vaccination, tracking rarer adverse events, improving adverse event classification, and tracking persons with missing data should be considered next-tier priorities.
As stated in the committee’s third letter report, “the committee notes the need for additional clarification by CDC to the states on the provisions of the [Smallpox Emergency Personnel Protection Act of 2003 (P.L. 108-20)], and for fact sheets or other explanatory materials for potential vaccinees” (IOM, 2003d). CDC has since developed a summary of the Smallpox Emergency Personnel Protection Act of 2003 (SEPPA) benefits and compensation for smallpox vaccine injuries that is posted to its website (CDC, 2003e). However, at the time of the writing of this report, the compensation language in the Smallpox Vaccine Information Statement (VIS) (CDC, 2003f) had not yet been updated to reflect the newly enacted legislation. To ensure that potential vaccinees are aware of the compensation available to them for any adverse events that are determined to be connected to the smallpox vaccine, the committee encourages CDC to update the VIS as soon as possible and publicize the existence of the fact sheet. When the interim final rule implementing SEPPA is published, this fact sheet should be expanded with further information on what types of compensation are available, how to apply for compensation, the statute of limitations and statute of repose, and any other relevant information. The issue of compensation for live born children who were exposed to the vaccine in utero should be clarified as well.
To help publicize the existence of these materials, the committee suggests that CDC notify states when these updated materials are available. The committee also encourages CDC to send a postvaccination fact sheet or letter explaining the compensation available under SEPPA to every person who has been identified as experiencing an adverse event. CDC could also