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Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders

Released:
January 9, 2003
Type:
Consensus Report
Topic(s):
Children and Families, Public Health
Activity:
Immunization Safety Review
Board(s):
Board on Population Health and Public Health Practice

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It is recommended that all infants, adolescents, and high-risk adults receive the hepatitis B vaccine for protection from serious liver disease. However, these recommendations have been viewed skeptically by some - largely because of a perception that hepatitis B infection is not a serious risk to the general population. There is also a theoretical basis for the hypothesis that vaccines, including the hepatitis B vaccine, could cause demyelinating neurological disorders, such as multiple sclerosis and Guillain-Barre Syndrome.

In the report, Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders, the Institute of Medicine Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that the hepatitis B vaccine causes demyelinating disorders.

Evidence of possible biological mechanisms that could produce this effect was weak. Additionally, the committee found that the epidemiological evidence favors rejection of a causal relationship between the hepatitis B vaccine in adults and multiple sclerosis. However, the evidence was inadequate to accept or reject a causal relationship between the hepatitis B vaccine and all other demyelinating conditions.

Because of the lack of epidemiological data on conditions other than MS in adults, the committee recommends further attention in the form of research and communication. However, 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.

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Report at a Glance

Report Brief. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders (PDF)

Other Reports by this Activity

  • Immunization Safety Review: Vaccines and Autism This eighth and final report of the Immunization Safety Review Committee examines the hypothesis that vaccines, specifically the measles-mumps-rubella (MMR) vaccine and thimerosal-containing vaccines, are causally associated with autism. The committee reviewed the extant published and unpublished epidemiological studies regarding causality and studies of potential biologic mechanisms by which these immunizations might cause autism. The committee concludes that the body of epidemiological evidence favors rejection of a causal relationship between the MMR vaccine and autism.
    Released: May 14, 2004
  • Immunization Safety Review: Influenza Vaccines and Neurological Complications Infection with the influenza virus can have a serious effect on the health of people of all ages, although it is particularly worrisome for infants, the elderly, and people with underlying heart or lung problems. At least 35,000 people die in the United States every year from influenza infection. A vaccine exists (the “flu” shot) that can greatly decrease the impact of influenza.
    Released: October 6, 2003
  • Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy With current recommendations calling for infants to receive multiple doses of vaccines during their first year of life and with sudden infant death syndrome (SIDS) the most frequent cause of death during the postneonatal period, it is important to respond to concerns that vaccination might play a role in sudden unexpected infant death.
    Released: March 31, 2003

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