The Interagency Vaccine Group asked the Immunization Safety Review Committee to address the concern that the hepatitis B vaccine causes demyelinating neurological disorders. A plasma-derived vaccine was first marketed in the United States in the early 1980s, and it was supplanted later in the decade by vaccines produced with the aid of recombinant technology.
Concern about the safety of the hepatitis B vaccine emerged with an analysis of the first three years of post-marketing surveillance reports on various demyelinating neurological disorders following administration of the plasma-derived vaccine. Those reports suggested a possible association with Guillain-Barré syndrome (GBS) (Shaw et al., 1988). In the early 1990s, a previous IOM committee concluded that the evidence was inadequate to accept or reject a causal relationship between hepatitis B vaccine and either GBS or a general category of central nervous system demyelinating diseases (IOM, 1994). Concern about the vaccine and neurological disorders has persisted, focusing most prominently on the possibility of a causal link with MS, a central nervous system demyelinating disease. Concerns were very salient in France recently and led to immunization policy change (as discussed in a subsequent section of the report).
For this review, the committee addressed the relationship between hepatitis B vaccine and the following neurological diseases: the central nervous system (CNS) demyelinating diseases of MS (onset or relapse), acute disseminated encephalomyelitis (ADEM), optic neuritis, and transverse myelitis and the peripheral nervous system (PNS) demyelinating diseases of GBS and brachial neuritis. The committee chose to focus on these specific conditions because they are serious neurological disorders and known clinical entities. Published epidemiological studies and case reports investigating their association with hepatitis B vaccine are available, and a substantial body of literature exists on the pathophysiology of several of these conditions (e.g., MS, ADEM, and GBS). Key features of these diseases, and of hepatitis B infection and the hepatitis B vaccine, are described below.
The committee recognizes that this report addresses only a portion of the full range of concerns about the hepatitis B vaccine. In particular, some members of the public believe that the hepatitis B vaccine, which is first administered to many infants within hours of birth, is associated with infant death. The death of any child—whether following immunization or a vaccine-preventable disease—is tragic, and the committee agrees that such deaths are of intense concern. However, in the context of the current review, it is not clear that the putative association in such infant deaths is with an immune-mediated neurological assault. The committee notes that the Interagency Group on Vaccines has dis-