Before the beginning of the smallpox vaccination program, the Centers for Disease Control and Prevention (CDC) asked the Institute of Medicine (IOM) to convene an expert committee to advise it on the implementation of a pre-event smallpox vaccination program. The committee was charged with providing “advice to the CDC and the program investigators on selected aspects of the smallpox program implementation and evaluation,” including the informed consent process for recipients of smallpox vaccine; professional education and training materials; communication plans developed by CDC for public health and medical professionals and the public; state smallpox vaccination implementation plans; CDC guidelines and instruments to identify potential vaccine recipients at high risk of vaccine adverse events and complications; CDC measures to ensure the early recognition, evaluation, and appropriate treatment of adverse events and complications of smallpox vaccination; CDC plans for collecting and analyzing data on vaccine immunogenicity, adverse events, complications, and vaccine coverage; and the achievement of overall goals of the smallpox vaccination program, such as vaccine coverage rate, equity of access, and adverse reaction rates. The IOM agreed to provide advice through a series of reports responding to CDC’s original charge and to new requests that would arise in the course of program implementation.

In a series of six brief timely reports released over 19 months, the committee presented its findings and offered recommendations to help guide the program and, later, its integration into the broader public health preparedness effort. In its first four reports, the committee’s recommendations focused on staff training and education, the informed consent and contraindications screening processes, the collection of data, follow-up and conduct of research related to vaccine adverse events, public communication, and the need for vaccine injury compensation. The committee also recommended evaluating all program components (including issues related to cost), defining smallpox preparedness to help establish a baseline or standard against which preparedness efforts could be measured, and using scenarios, including multithreat scenarios, to sharpen national and local plans to respond to smallpox and other threats. In its fifth and sixth reports, the committee responded to CDC’s request to comment on its draft indicators of smallpox preparedness (in the context of a larger set of public health preparedness indicators), on the value of using scenarios, and on the state of the science (across other disciplines, such as disaster response) on the conduct of exercises as a strategy for evaluating and testing preparedness. The six individual letter reports have been gathered into a larger archival work that also responds more substantively on the last item in the charge, the achievement of overall goals of the smallpox vaccination program.

This final report consists of four newly written chapters and seven

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