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Immunization Safety Review: 
Hepatitis B Vaccine and Demyelinating Neurological Disorders
Overview of the Institute of Medicine (IOM) Report
(Released May 30, 2002)
Contents of this page:
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In 2000, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) to establish an independent expert committee to review hypotheses about existing immunization safety concerns.  The first report on measles, mumps, rubella (MMR) vaccine and autism was released in April 2001, the second report on thimerosal- containing vaccines and neurodevelopmental disorders was released in October 2001 and the third report, which addressed multiple immunizations and immune dysfunction, was released in February 2002. 

In the United States, current recommendations call for all infants, adolescents and high-risk adults to receive the hepatitis B vaccine for protection from serious liver disease, including cirrhosis and hepatocellular carcinoma. These recommendations have been viewed skeptically by some because of concerns about the safety of the vaccine and because of a perception that hepatitis B infection is not a serious risk to the general population. The Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that the hepatitis B vaccine causes demylelinating neurological disorders, such as multiple sclerosis and Guillain-Barre syndrome.


The IOM's Immunization Safety Review Committee found that the epidemiological evidence (that is, findings from studies of vaccine-exposed populations and their comparison unvaccinated control groups or of patients with these diseases and their comparison groups) favors rejection of a causal relationship between the hepatitis B vaccine and multiple sclerosis. The evidence was inadequate to accept or reject a causal relationship between the hepatitis B vaccine and other known specific demyelinating conditions.


The Committee does not recommend that national and federal vaccine advisory bodies review the hepatitis B vaccine on the basis of concerns about demyelinating disorders. However, the Committee recommends further public health attention on the issue in the form of additional research and communication to increase understanding of the basis for hepatitis B vaccine recommendations in the United States.


Next steps
The Committee has made helpful recommendations about research and communication issues which are important to help resolve outstanding issues related to the hypothesis that the hepatitis B vaccine causes demyelinating disorders. These recommendations will be considered in depth by Public Health Service agencies over the next several months.

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This page last modified on May 30, 2002


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