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immunization Safety Review: Thimero s al - C ontaining Vaccines and Neurodevelopmental Disorders Immunization to protect infants and children from vaccine-preventable dis- eases is one of the greatest achievements in public health. The use of vaccines is not without risks, however. It is well established, for example, that the oral polio vaccine can on rare occasion cause paralytic polio, that some influenza vaccines have been associated with a risk of Guillain-Barre syndrome, and that vaccines sometimes cause anaphylactic shock. In recent years, the number of concerns regarding the safety of immunizations seems to have increased. Given the wide- spread use of vaccines, state mandates requiring vaccination of children for en- try into school or daycare, and the importance of ensuring that trust in immuni- zation programs is justified, it is essential that these safety concerns receive assiduous attention. The Immunization Safety Review Committee was established by the Insti- tute of Medicine (IOM) to evaluate the available evidence on a series of immu- nization safety concerns in order to present conclusions and recommendations regarding possible causal associations between vaccines and certain adverse outcomes. The committee's task also includes assessing the broader significance for society of these immunization safety issues. In this report, the committee examines the hypothesis of whether or not the use of vaccines containing the preservative thimerosal can cause neurodevelop- mental disorders (NDDs), specifically autism, attention deficit/hyperactivity dis- order (ADHD), and speech or language delay. Thimerosal, an organic mercury compound that is metabolized to ethylmercury and thiosalicylate, has been used since the 1930s as a preservative in some vaccines. Food and Drug Administra- 19