safety assessments made by the DSMB. CDC has a responsibility for regular communication to the public about the findings from the DSMB.

Treatment of Vaccine Complications

CDC asked the committee for advice on whether the proposed safety system provides timely access to VIG. The system that CDC is currently proposing instructs the treating physician to contact the designated state official; the state would inform CDC of a request for VIG and/or cidofovir (Vistide); the CDC clinical team would assess the request with the state and treating physician; CDC Drug Services and the National Pharmaceutical Stockpile would coordinate release of VIG and/or cidofovir; and the treating physician would be designated as a co-investigator on the IND protocol. The committee generally believes that the currently proposed system is adequate in this regard, although the potential variability of cases requires case-by-case consideration and treatment. The committee encourages CDC to assemble a group of national experts that could be consulted on serious vaccinia adverse reactions and could provide individualized treatment regimens where necessary. The committee would like to gain more information about the details of the VIG and cidofovir distribution plans, in particular, the criteria for distribution. CDC should carefully monitor the characteristics of the requests for VIG and cidofovir and use these data as a form of passive surveillance.

CDC Safety System Guidance to States

CDC asked the committee to provide advice on whether the proposed safety system will provide for the development of state capacity, such that states will be able to manage smallpox vaccine adverse events if smallpox vaccination becomes routine. The committee felt that they did not have enough detailed information about the state plans to adequately address this question.

Without more specific information on the state plans, it is unclear to the committee if the states are sufficiently prepared to manage adverse reactions in phase I or phase II. But based on the perspectives of state and local public health organizations (Hardy, 2002; NACCHO, 2002), the committee recommends CDC evaluate each state’s capacity for managing adverse reactions before indicating that a state is ready to begin vaccinations.

Evaluation of states’ experiences with management of adverse reactions during phase I should shed more light on their level of preparedness to implement phase II. Should routine vaccination of the general population commence, states’ preparedness will have to be evaluated again.

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