Publication

Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders


Released:

Report at a Glance

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

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.