Adverse Effects of Pertussis and Rubella Vaccines (1991) / Chapter Skim
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6 Evidence Concerning Pertussis Vaccines and Other Illnesses and Conditions
6 Evidence Concerning Pertussis Vaccines and Other Illnesses and Conditions
Pages 144-186
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From page 144... ...
Release of mediators depends typically upon the interaction of antigen with specific antibodies of the immunoglobulin E (IgE) class that are bound to the mast cells and basophils.
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From page 145... ...
Endotoxin shock has a clinical presentation different from that of anaphylaxis, however; it develops more slowly and is almost always associated with disseminated intravascular coagulation, with consumption of clotting factors and hemorrhage (Colman, 1989; Suffredini et al., 1989a,b)
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From page 146... ...
. History of Suspected Association with Pertussis Vaccines Identical twins died 16 and 20 hours after their second DPT shot given at age 10 months (Werne and Garrow, 1946~.
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From page 147... ...
occurring within 28 days of DPT immunization were reported through the CDC's MSAEFI system from 1978 to 1990, a period in which approximately 80.1 million doses of DPT vaccine were administered through public mechanisms in the United States (J. Mullen, Centers for Disease Control, personal communication, 1990~.
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From page 148... ...
pertussis vaccine has been shown to facilitate the induction of anaphylactic shock in the rat and mouse but not in the hamster, guinea pig, rabbit, or dog (Arora et al., 1970; Chang and Gottshall, 1974; Csaba and Muszbek, 1972; Munoz et al., 19879. Injection of pertussis vaccine (0.1 ml/mouse, roughly 200 times the human dose)
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From page 149... ...
In short, data do not exist at present to indicate that the endotoxin present in DPT vaccines plays a role in the anaphylaxis associated with injection of DPT. Nor do data exist to support a role for endotoxin in the other immunologic reactions or in the encephalopathies that have been suspected sequelae of DPT immunization.
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From page 150... ...
Furthermore, the animal models described to date employ antigen loads, dosage schedules, pathologic endpoints, add-on antigens, or other experimental conditions that deviate from the human situation that is the subject of concern. Consequently, although the data from animal experiments may be useful in formulating or modifying hypotheses, they do not implicate an immunologic or endotoxin-initiated basis for possible adverse events following DPT immunization.
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From page 151... ...
occurring within 28 days of DPT immunization from 1978 to 1990, a period in which approximately 80.1 million doses of DPT vaccine were administered through public mechanisms in the United States (J. Mullen, Centers
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From page 152... ...
Conclusion There is no evidence to indicate a causal relation between DPT vaccine or the pertussis component of DPT vaccine and autism. ERYTHEMA MULTIFORME OR OTHER RASH Clinical Description Erythema multiforme is an acute, self-limited eruption characterized by symmetric erythematous, edematous, or bullous lesions of the skin or mucous membranes (or both)
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From page 153... ...
Rash as an adverse reaction to DPT vaccine appears to be rare; several reports of large series do not mention rashes (Cody et al., 1981~. Isolated case reports describe a variety of self-limited rashes following DPT immunization, ranging from eczematous reactions (Hopper, 1961; Illingworth, 1987)
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From page 154... ...
The relation is biologically plausible, since erythema multiforme is thought to be a dermal hypersensitivity reaction to a drug or other foreign antigen and pertussis vaccine could provide such a sensitizing antigen. The temporal relation between DPT injection and the onset of rash suggests a possible causal relation.
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From page 155... ...
Mullen, Centers for Disease Control, personal communication, 1990~. All 11 cases received at least one other vaccine at the time of DPT immunization: 6 cases received OPV, 1 case received OPV plus mumps monovalent vaccine, 1 case received OPV plus hepatitis B conjugate vaccine, and 3 cases received OPV plus MMR.
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From page 156... ...
There are no experimental data bearing on a possible biologic mechanism Conclusion There is insufficient evidence to indicate a causal relation between DPT vaccine or the pertussis component of DPT vaccine and GBS. PERIPHERAL MONONEUROPATHY Clinical Description Peripheral mononeuropathy is a syndrome of sensory, motor, reflex, and vasomotor symptoms, singly or in any combination, produced by disease of a single peripheral nerve.
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From page 157... ...
There are no data bearing on a possible biologic mechanism. Conclusion There is insufficient evidence to indicate a causal relation between DPT vaccine or the pertussis component of DPr vaccine and peripheral mononeuropathy.
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From page 158... ...
reviewed a case series of 44 children, ages 3 months to 14 years, with autoimmune hemolytic anemia. The authors identified one case of acute disease following DPT immunization.
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Summary Although the body of evidence concerning the possible relation between vaccination with DPT or its pertussis component and hemolytic anemia is limited to rare case reports, the case described by Coulter and Fisher (1985) is suggestive of a causal relation because hemolytic anemia was detected 6 days after a DPT immunization on two separate occasions.
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From page 160... ...
and six children who cried persistently for more than 3 hours following DPT immunization. A physical examination and medical history were conducted on and blood samples were collected from each child.
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From page 161... ...
Summary Information concerning the possible relation between vaccination with DPT or its pertussis component and IDDM consists of one controlled study of plasma insulin and serum glucose levels in 11 children with HlIE or persistent crying following DPT immunization, one case report in which the authors suggested that a concomitant viral infection rather than the immunization was the causative factor, and animal studies of the effects of wholecell pertussis vaccines or pertussis toxin on insulin and glucose metabolism. No biologic mechanism supporting a causal association has been proposed.
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From page 162... ...
Descriptive Epidemiology Given the definition of learning disability, prevalence rates are especially sensitive to the cutoff score used to define the difference between ability and achievement. These cutoff scores are generally represented as standard deviations from the mean.
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Mullen, Centers for Disease Control, personal communication, 1990~. Of the six cases of hyperactivity, four cases received OPV at the time of DPT immunization and two cases received OPV plus MMR.
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From page 164... ...
There are no data bearing on a possible biologic mechanism. Conclusion There is insufficient evidence to indicate a causal relation between DPT vaccine or the pertussis component of DPT vaccine and the development of learning disabilities or ADD.
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From page 165... ...
Crying occurred after DPT immunization in 432 (35 percent) of the children; prolonged (duration not specified)
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Controlled Epidemiologic Studies A number of studies have examined rates of protracted crying and screaming in children following DPT immunization. In one of the larger controlled studies conducted to date, Cody and colleagues (1981)
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. Los Angeles County in 1986, identified six children who cried persistently for more than 3 hours following DPT immunization.
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The latter study reported no association between high-pitched or unusual crying following DPT immunization and a subsequent necrologic abnormality at age 3 years. However, it is not surprising that an event as infrequent as chronic necrologic damage was not detected given the study's small sample.
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From page 169... ...
Incidence rates are estimated to range from 0.1 to 6 percent of recipients of a DPT injection and vary with the type and dose of vaccine and with the immunization site. Evidence is insufficient to indicate whether pertussis vaccine-associated protracted, inconsolable, or high-pitched crying or screaming does, or does not, lead to chronic necrologic damage.
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From page 170... ...
. Only one of these cases occurred within 7 days of DPT immunization (Bellman et al., 1982~.
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From page 171... ...
Conclusion The evidence does not indicate a causal relation between DPT vaccine or the pertussis component of DPT vaccine and Reye syndrome. SHOCK AND "UNUSUAL SHOCK-LIKE STATE" WITH HYPOTONICITY, HYPORESPONSIVENESS, AND SHORT-LIVED CONVULSIONS, USUALLY FEBRILE Clinical Description Shock or shock-like state, collapse, and hypotonic, hyporesponsive epi sodes (HHE)
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From page 172... ...
Feery and colleagues (1985) compared the incidence and type of adverse events following administration of plain or adsorbed DPT vaccines in a masked prospective study of 2,041 vaccinations in 1,075 infants receiving routine childhood immunization.
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examined physician and nurse reports from the Los Angeles area to identify severe adverse events following DPT vaccination. Cases were considered eligible for study if the onset of the adverse event was within 48 hours of immunization and if the study staff was able to evaluate the child within 24 hours of symptom onset.
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From page 175... ...
The authors concluded that there was no evidence that any of the nine cases of HHE suffered chronic necrologic damage as a result of their HHE. Eight cases of anaphylaxis or collapse after DPT immunization were reported in the North West Thames study (Pollock and Morris, 1983; see section on Anaphylaxis for study description)
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From page 176... ...
Blumberg and colleagues (1988) , in a surveillance study conducted in Los Angeles County in 1986, identified five children who had HHE following DPT immunization.
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From page 177... ...
The available evidence does not implicate the pertussis component specifically. Evidence is insufficient to indicate a causal relation between HHE following DPT immunization and the subsequent development of permanent necrologic damage.
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From page 178... ...
following DPT vaccination were reported through the CDC's MSAEFI system from 1978 to 1990, a period in which approximately 80.1 million doses of DPT vaccine were administered through public mechanisms in the United States (J. Mullen, Centers for Disease Control, personal communication, 1990~.
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1989. Analyses of adverse reactions to diphtheria and tetanus toxoids and pertussis vaccine by vaccine lot, endotoxin content, pertussis vaccine potency and percentage of mouse weight gain.
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In press. Pathophysiology of reactions associated with pertussis vaccine.
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1972. The effect of Bordetella pertussis vaccine on protease sensitivity and on the anaphylactic protease production in rats.
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1989. Immunoglobulin E response to pertussis toxin in whooping cough and after immunization with a whole-cell and an acellular pertussis vaccine.
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1984. Erythema multiforme following DPT vaccination (letter)
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1974. Studies of adrenergic mechanisms in relation to histamine sensitivity in children immunized with Bordetella pertussis vaccine.
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1985. Pertussis toxin is required for pertussis vaccine encephalopathy.
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1970. Autoimmune hemolytic anemia: natural history and viral-immunologic interactions in childhood.
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