In particular, the committee would like to reaffirm the need for a pause in the program, before the vaccine is offered more widely, and also make some specific suggestions about the recently issued guidance. In a forthcoming report, the committee intends to focus on issues surrounding definitions and measurements of smallpox preparedness and its integration into broader bioterrorism readiness. The committee also will discuss screening and follow-up issues relevant to the continuation of the vaccination program, and answer specific questions asked by CDC and its partners at the May 1, 2003, committee meeting.

GENERAL COMMENTS

The committee reiterates its high regard for CDC and its partners and the remarkable amount of work completed in the national smallpox vaccination program, especially in the context of additional strain on all resources caused by the emergence and spread of Severe Acute Respiratory Syndrome (SARS). In fact, the committee heard from program administrators that the effective response to SARS both at the national and local level was at least in part facilitated by smallpox preparedness efforts, in particular the improved communication and collaboration among parties.

The committee has noted that the safety system implemented by CDC worked as intended, bringing the cardiac adverse events to the immediate attention of the Advisory Committee on Immunization Practices (ACIP) Smallpox Vaccine Safety Working Group and program administrators at CDC who responded promptly by modifying screening procedures and informed consent materials. The program has progressed with deliberation and caution. Thus far, the screening of potential vaccinees may have played a role in preventing several of the historically expected moderate-to-severe adverse events (e.g., eczema vaccinatum, progressive vaccinia) to the vaccine in 36,217 people vaccinated in the civilian program as of May 9, 2003 (CDC, 2003c). Also, it appears that vaccinee education on the risk of vaccinia transmission to contacts and measures taken to prevent it with appropriate bandaging and site care have worked well and may in part account for the absence of reported cases of vaccinia transmission from civilian vaccinees to either health care or personal contacts.

Although safety data to date have not revealed many of the moderate-to-severe adverse events or transmission that historically have been associated with smallpox vaccination, this does not necessarily mean that more robust trends will not be discovered later in the process, as vaccination numbers increase and more occupationally diverse volunteers consider vaccination.

The enactment of the smallpox vaccination compensation legislation (Smallpox Emergency Personnel Protection Act of 2003; P.L. 108-20) is



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