Comprehensive Review of Federal Vaccine Safety Programs and Public Health Activities, December 2008   [open pdf - 352KB]

"The evaluation of safety for vaccines is conducted through a network of diverse, yet integrated activities that cuts across Federal agency responsibilities and includes the private sector and academic investigators. This document describes the United States vaccine safety system and articulates the roles and responsibilities of various agencies and their activities in evaluating vaccine safety. The development, licensure and widespread use of a vaccine involves activities and programs from a broad range of groups, including State health departments, academia, industry, healthcare providers, professional organizations, third party payers, managed care organizations, philanthropic and service organizations, and agencies within the Department of Health and Human Services (HHS), including the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the National Vaccine Injury Compensation Program (VICP) in the Health Resources and Services Administration (HRSA). The Department of Veterans Affairs (VA), the Department of Defense (DoD), and international organizations such as the World Health Organization (WHO) also contribute to knowledge about vaccines and their widespread use. Ensuring vaccines are as safe as possible is the goal of these collective endeavors. Safety assessment is a continuous process. As new information becomes available about vaccine safety and efficacy, changes are made in manufacturing and/or recommendations for use."

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U.S. Department of Health and Human Services: http://www.hhs.gov/
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