sustained by an individual the direct result of administration to the individual of a covered countermeasure during the effective period of the Declaration” (U.S. Congress, 2003). (The term ‘Declaration’ refers to the Declaration Regarding Administration of Smallpox Countermeasures issued by the Secretary on January 24, 2003, and published in the Federal Register on January 28, 2003.) The committee believes that it will be important to clarify and explain in the interim final rule the interpretation of “a direct result of … a covered countermeasure” (i.e., smallpox vaccine), since this will affect the level of evidence required for an injury to be covered. The committee encourages CDC to work with those who are developing the interim final rule for the smallpox vaccine injury table to clarify the conditions under which longer-term sequelae from the smallpox vaccine will be considered to be a direct result of smallpox vaccination.

The last two key messages of the report are:

The safety system appears to be working well to date, but CDC and its partners should remain vigilant to ensure the continuing safe implementation of the program.

The development of a research agenda for the smallpox vaccination program is important to ensuring the long-term success of smallpox preparedness efforts, as well as providing useful information for overall public health preparedness.


The committee offers its assistance in the future in any areas that would prove useful to CDC. Two possible areas include developing a research agenda to support and evaluate the implementation of the smallpox preparedness program and exploring how to better integrate smallpox preparedness into overall public health preparedness.

In closing, the committee summarizes several of the key messages set forth in this report:

  • First, smallpox is not the only threat to the public’s health, and vaccination is not the only tool for smallpox preparedness.

  • Second, to improve smallpox preparedness, it is essential to “plan, train to the plan, exercise to the plan, and revise the plan” (Selecky, 2003).

  • Third, vaccinating members of the general public beyond the key personnel states deem necessary for preparedness should proceed only un-

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