News
Immunization Safety
Review:
Hepatitis B Vaccine and Demyelinating Neurological Disorders
Overview
of the Institute of Medicine (IOM) Report
(Released May 30,
2002)
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Background
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.
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Conclusions
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.
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Recommendations
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.
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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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