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Susan S. Ellenberg, PhD, Mary A. Foulkes, PhD, Karen Midthun, MD and Karen L. Goldenthal, MD

At the time this article was written, Susan S. Ellenberg was with the Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Md. Mary A. Foulkes, Karen Midthun, and Karen L. Goldenthal are with the Center for Biologics Evaluation and Research, US Food and Drug Administration.

Correspondence: Requests for reprints should be sent to Susan S. Ellenberg, PhD, University of Pennsylvania School of Medicine, Center for Clinical Epidemiology and Biostatistics, Division of Biostatistics, Blockley Hall, Room 611, 423 Guardian Dr, Philadelphia, PA 19104-6021 (email: sellenbe{at}cceb.upenn.edu).

Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled "Evaluation of New Vaccines: How Much Safety Data?" was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines.

Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered.

The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions.

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