Susan s Ellenberg ^1*, Mary A Foulkes ¹, Karen Midthun ¹, Karen l Goldenthal ¹

¹ fda

^* To whom correspondence should be addressed. E-mail: sellenbe{at}cceb.upenn.edu.

	Abstract

Public concerns about the safety of vaccines regularly arise. In November 2000, a workshop was convened by the U.S. Public Health Service agencies, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Health Resources and Services Administration (HRSA), to discuss appropriate methods for evaluating the safety of new vaccines. Workshop presentations addressed the current standards and approaches for new vaccine evaluation and post-licensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered. The advantages and disadvantages of conducting larger controlled trials prior to licensure and/or widespread use of a new vaccine were presented and discussed. This paper summarizes these presentations and discussion.

Key Words: Health Policy, Immunization/Vaccines, Statistics/Evaluation/Research

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