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Public Health Rep. 1997 Jan-Feb;112(1):10-20; discussion 21.

The complicated task of monitoring vaccine safety.

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Division of Biostatistics and Epidemiology, FDA, USA.


Vaccination is an essential component of modern public health programs and is among our most cost-effective medical interventions. Yet despite vaccines' clear effectiveness in reducing risks of diseases that previously attacked large proportions of the population, caused many deaths, and left many people with permanent disabilities, current vaccination policies are not without controversy. Vaccines, like all other pharmaceutical products, are not entirely risk-free; while most known side effects are minor and self-limited, some vaccines have been associated with very rare but serious adverse effects. Because such rare effects are often not evident until vaccines come into widespread use, the Federal government maintains ongoing surveillance programs to monitor vaccine safety. The interpretation of data from such programs is complex and is associated with substantial uncertainty. A continual effort to monitor these data effectively and to develop more precise ways of assessing risks of vaccines is necessary to ensure public confidence in immunization programs.

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