Adverse Events Associated with Childhood Vaccines Evidence Bearing on Causality (1994) / Chapter Skim
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8 Hepatitis B Vaccines
8 Hepatitis B Vaccines
Pages 211-235
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From page 211... ...
Of those who recover from acute hepatitis, up to 15 percent become chronic carriers, that is, have chronic hepatitis B virus infection. There are major differences between children and adults regarding the development of the chronic carrier state.
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From page 212... ...
The other was labeled MS-2 and was later confirmed to be hepatitis B virus. Those investigators found that a 1:10 dilution of serum infected with hepatitis B virus boiled for 1 minute lost its infectivity but retained its antigenicity and prevented or modified hepatitis B virus infection in approximately 70 percent of vaccinated subjects later challenged with infective MS-2 serum (Krugman and Giles, 1973; Krugman et al., 1970, 1971~.
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From page 213... ...
BIOLOGIC EVENTS FOLLOWING IMMUNIZATION The antibodies produced after infection with hepatitis B virus or after administration of plasma-derived vaccine or recombinant vaccine are alike in terms of their ability to elicit protective determinants that are active against all subtypes of the virus (Heuser et al., 19871. In the United States,
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From page 214... ...
The anterolateral thigh is the preferred site of vaccine injection in infants. Recombinant vaccine has decreased immunogenicity compared with that of plasma-derived vaccine when the vaccine is administered by the intradermal route, so this route of administration is not recommended by the Centers for Disease Control and Prevention.
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From page 215... ...
The current recommendations incorporate administration of a combination of vaccine and immune globulin with the initial dose shortly after birth; this is followed by administration of vaccine alone at 1- and 6-month intervals. Trials of more than 12 separate recombinant vaccines have been conducted in more than 25 countries and have involved more than 100,000 recipients.
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From page 216... ...
Evidence for Association Biologic Plausibility Chapter 3 presents background information on the biologic plausibility of a causal relation between vaccines and demyelinating disease. The association with GBS has been reported from various countries and with various versions of both plasma-derived and recombinant hepatitis B vaccines.
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From page 217... ...
Relative risks for GBS following hepatitis B vaccination were calculated under a variety of assumptions, specifically, a 6- or 8-week atrisk interval and risk evenly distributed among three doses versus all risk associated with the first dose. Statistically significant increases in risk were found under all assumptions when the CDC data were used for comparison purposes, but only with a 6-week at-risk interval after the first vaccine dose when the Olmsted County data were used.
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From page 218... ...
Controlled Clinical Trials None of the clinical trials reviewed by the committee contained information regarding hepatitis B vaccine and GBS.
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From page 219... ...
OTHER DEMYELINATING DISEASES Clinical Description Three central nervous system demyelinating diseases have been reported to occur following hepatitis B vaccination: a chronic demyelinating disease, multiple sclerosis, and two focal demyelinating lesions, optic neuritis and transverse myelitis. In patients with multiple sclerosis, demyelinating lesions occur in multiple locations and at different times.
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From page 220... ...
Evidence for Association Biologic Plausibility Chapter 3 contains a discussion of the biologic plausibility of a causal relation between hepatitis B vaccine and demyelinating disease. The reports suggesting a relation between vaccination and multiple sclerosis have largely been associated with hepatitis B vaccine.
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From page 221... ...
Controlled Observational Studies None. Controlled Clinical Trials None of the clinical trials reviewed by the committee contained information regarding hepatitis B vaccine and transverse myelitis, optic neuritis, multiple sclerosis, or other central demyelinating diseases.
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From page 222... ...
The possible relation between hepatitis B vaccine and central demyelinating diseases has not been investigated in controlled studies, however. The background incidence rate of these disorders is not particularly well established, nor is the true number of instances of these adverse events following hepatitis B immunization with the recombinant vaccines in use today.
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From page 223... ...
In the serum sickness-like illness associated with acute hepatitis B virus infection, the arthritis, fever, and rash are generally of short duration (3-7 days)
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From page 224... ...
Presumably, the immune complex formation during the period of antigen excess is responsible for the transient arthritis observed in patients in the course of acute hepatitis B virus infection. In addition to the serum sickness-like syndrome associated with hepatitis B infection, arthropathies are among the most common manifestations during the prodromal period of acute hepatitis B virus infection.
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From page 225... ...
Although the rashes in the nine individuals in whom they occurred were not defined, there are reports in the literature of erythema multiforme following hepatitis B vaccination (Feldshon and Sampliner, 1984; Milstien and Kuritsky, 1986; Wakeel and White, 19921. Although both erythema multiforme and erythema nodosum may represent hypersensitivity reactions, neither has been observed sufficiently frequently to support a causal relation with the hepatitis B vaccine.
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From page 226... ...
Causality Argument On the basis of the two largest available observational studies, arthropathy appears to be unusual following vaccination against hepatitis B virus. On the basis of VAERS reports, the possibility exists that a hypersensitivity arthritis occurred in the 17 individuals who developed acute arthritis associated with fever with or without an associated rash.
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From page 227... ...
Since the arthritis that occurs in patients with acute hepatitis B virus infection appears to occur only during the period of antigen excess, it is almost invariably self-limited and appears to subside as the level of antibody increases. It is therefore difficult to relate arthropathy following receipt of the hepatitis B vaccine to the same sort of serum sickness-like antigen-antibody reaction.
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From page 228... ...
This does not, however, justify a conclusion that women are more susceptible than men to anaphylaxis caused by hepatitis B vaccine, because women represent the majority of health care professionals for whom hepatitis B vaccine has been recommended. Evidence for Association Biologic Plausibility The possibility of a causal relation between hepatitis B vaccination and anaphylaxis is supported by biologic plausibility, by the temporal sequence of observed events following vaccination, and by the observation of a spectrum of host responses to the hepatitis B vaccine that follow a logical biologic gradient from true anaphylaxis to milder hypersensitivity reactions.
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From page 229... ...
A possible explanation for the occurrence of anaphylaxis after the first vaccine injection is that the patients were sensitized to thimerosal or yeast protein, both of which are components of recombinant vaccines (Kirkland, 1990~. An equally tenable hypothesis is that the three patients had previously been exposed to antigens similar to those present in the recombinant hepatitis B vaccine.
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From page 230... ...
Causality Argument The possibility of a causal relation between hepatitis B vaccination and anaphylaxis is supported by biologic plausibility, by the temporal sequence of observed events following vaccination, and by the observation of a spectrum of host responses to the hepatitis B vaccine that follow a logical biologic gradient from true anaphylaxis to milder hypersensitivity reactions. Biologic plausibility derives from the knowledge that injection of foreign protein into humans can be expected to elicit, in some percentage of recipients, IgE-mediated responses that present as anaphylaxis.
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From page 231... ...
There are reports in VAERS of SIDS following immunization with hepatitis B vaccine given in conjunction with other vaccines. Conclusion The evidence establishes a causal relation between hepatitis B vaccine and fatal anaphylaxis.
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From page 232... ...
Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine. Lancet 1983;2:10991102.
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From page 233... ...
Erythema nodosum after recombinant hepatitis B vaccine. New England Journal of Medicine 1989;321:1198- 1199.
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From page 234... ...
Wands JR, Mann E, Alpert E The pathogenesis of arthritis associated with acute hepatitis B surface antigen-positive hepatitis: complement activation and characterization of circulating immune complexes.
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From page 235... ...
HEPATITIS B VACCINES 235 Wong VCW, Ip HMP, Reesink HW. Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis B vaccine and hepatitis B immunoglobulin.
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