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Executive Summary
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From page 1... ... The Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that the hepatitis B vaccine causes demyelinating neurological disorders, such as multiple sclerosis and Guillain-Barre syndrome. There is a theoretical basis for the hypothesis that vaccines, including the hepatitis B vaccine, could cause demyelinating disorders. Read the entire page →
From page 2... ... While all of the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. In this report, which is the fourth in the series, the committee examines the hypothesis that the hepatitis B vaccine increases the risk for demyelinating disorders of the central or peripheral nervous systems, including multiple sclerosis (MS) Read the entire page →
From page 3... ... does or does not cause the adverse event in question. The weight of the available clinical and epidemiological evidence determines whether it is possible to shift from that neutral position to a finding for causality ("the evidence favors acceptance of a causal relationship") Read the entire page →
From page 4... ... , and transverse myelitis; and the peripheral nervous system (PNS) demyelinating diseases of GBS and brachial neuritis. Read the entire page →
From page 5... ... Optic neuritis can occur as an isolated monophasic disease, or it may be a symptom of other demyelinating diseases such as ADEM or MS. ADEM, an inflammatory demyelinating disease of the CNS that can result in permanent and severe neurological disability, occurs most commonly in children and adolescents. Read the entire page →
From page 6... ... Most patients will improve and return to normal functioning within 6 to 9 months, but some patients experience relapses or a prolonged disease course with residual neurological deficits. Brachial neuritis is characterized by a deep, severe pain in the shoulder and upper arm. Read the entire page →
From page 7... ... Immunization is also recommended for all unimmunized adolescents and for adults at high risk of exposure to HBV, such as health care workers. EVIDENCE REVIEWED BY THE COMMITTEE For its evaluation of the hypothesis on hepatitis B vaccine and demyelinating neurological disorders, the committee commissioned a background paper. Read the entire page →
From page 8... ... BIOLOGICAL MECHANISMS ASSESSMENT Three mechanisms- molecular mimicry, bystander activation, and superantigen stimulation�can be posited as the theoretical ways in which immunization of any kind (either through infection or vaccination) could cause the development of demyelinating diseases of the central and peripheral nervous systems. Read the entire page →
From page 9... ... Several vaccines other than hepatitis B vaccine are associated with demyelinating diseases of either the central or peripheral nervous system. Both rabies and measles vaccines are rarely associated with ADEM, and the swine influenza vaccine used in 197~1977 in the United States was associated with an increased risk of developing GBS (CDC, 2001b) Read the entire page →
From page 10... ... Because none of the evidence is specific to the hepatitis B vaccine, the committee concludes that there is weak evidence for biological mechanisms by which hepatitis B vaccination could possibly influence an individual's risk of the central or peripheral nervous system disorders of MS, first episode of COD, ADEM, optic neuritis, transverse myelitis, GBS, or brachial neuritis. SIGNIFICANCE ASSESSMENT In formulating the breadth and direction of the recommended public health response, the committee considers not only its conclusions regarding causality and biological mechanisms but also the significance of the immunization safety issues for society the context in which policy decisions must be made. Read the entire page →
From page 11... ... Although concern about neurological disorders following immunization is justified on He basis of Heir total burden to individuals and to society and the lmown relationship of some vaccines to some neurological conditions, the hepatitis B vaccine prevents serious and usually fatal liver disease. However, the benefits of hepatitis B vaccine are realized long after immunization, and because He population at highest risk of hepatitis B infection is in adolescents, young adults, and members of high-nsk occupations, the recommendation to universally immunize newborns and infants is difficult for some parents and clinicians to understand. Read the entire page →
From page 12... ... However, the committee does not recommend a policy review of the hepatitis B vaccine by any of the national and federal vaccine advisory bodies on the basis of concerns about demyelinating neurological disorders. Research Although the committee concluded that the epidemiological evidence is inadequate to accept or reject a causal relationship between the hepatitis B vaccine and most of the demyelinating disorders it reviewed, the committee found a theoretical basis for the hypothesis when it considered biological mechanisms. Read the entire page →
From page 13... ... The lack of standardized case definition for adverse events following vaccination is a recurring concern for the committee and for all who study immunization safety. Specifically, the committee recommends the development of case definitions and guidance for diagnostic evaluation of the demyelinating disorders it has reviewed for purposes of improved vaccine adverse event surveillance and, when appropriate, causality assessment. Read the entire page →
From page 14... ... BOX ES-1 Committee Conclusions and Reconn~endations SCIENTIFIC ASSESSMENT Causality Conclusions The committee concludes that the evidence favors rejection of a causal relationship between hepatitis B vaccine administered to adults and incident multiple sclerosis. The committee also concludes that the evidence favors rejection of a causal relationship between hepatitis B vaccine administered to adults and multiple sclerosis relapse. Read the entire page →
From page 15... ... The committee recommends continued surveillance of hepatitis B disease and increased surveillance of secondary diseases such as cirrhosis and hepatocellular carcinoma. Basic arid Clinical Science The committee recommends continued research In animal and in vitro models, as well as In humans, on the mechanisms of immune-mediated neurological disease possibly associated with exposure to vaccines. Read the entire page →
From page 16... ... Suspected mechanisms involved in multiple sclerosis and putative role of hepatitis B vaccine in multiple sclerosis. Commissioned Background PaperforIOMImmunization Safety Review Committee. Read the entire page →

From page 1...

... The Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that the hepatitis B vaccine causes demyelinating neurological disorders, such as multiple sclerosis and Guillain-Barre syndrome. There is a theoretical basis for the hypothesis that vaccines, including the hepatitis B vaccine, could cause demyelinating disorders.

Executive Summary Pages 1-16

Executive Summary
Pages 1-16