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October 2009, Vol 99, No. S2 | American Journal of Public Health S345-S350
© 2009 American Public Health Association
DOI: 10.2105/AJPH.2008.143081


FRAMING HEALTH MATTERS

What Should an Ideal Vaccine Postlicensure Safety System Be?

Marie R. Griffin, MD, MPH, M. Miles Braun, MD, MPH and Kenneth J. Bart, MD, MPH

Marie R. Griffin is with the Departments of Preventive Medicine and Medicine, School of Medicine, Vanderbilt University and the Mid-South Geriatric Research Education and Clinical Center and Clinical Research Center of Excellence, VA Tennessee Valley Health Care System, Nashville. At the time this article was written, M. Miles Braun was with the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD. Kenneth J. Bart was with the National Vaccine Program Office, Office of Public Health and Science, Office of the Secretary of Health and Human Services, Washington, DC.

Correspondence: Correspondence should be sent to Kenneth J. Bart, MD, MPH, 9917 Conestoga Way, Potomac, MD 20854 (e-mail: kennethbart{at}yahoo.com). Reprints can be ordered at http://www.ajph.org by clicking on the "Reprints/Eprints" link.

In 2007 the National Vaccine Program, along with the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Health Resources and Services Administration, sponsored a public conference titled "Vaccine Safety Evaluation: Post Marketing Surveillance." The objective was to discuss enhanced approaches to postlicensure evaluation of vaccine safety, including active and passive surveillance systems and special studies. The conference participants reviewed the evolution of the assessment of vaccine safety, detailed current national approaches to postmarketing safety, and offered new approaches to evaluating vaccine safety. A number of the participants recommended that information systems be expanded to include reliable information on vaccination and health outcomes in large populations. We summarize the major meeting presentations and discussions.







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