Vaccine Supply and Innovation (1985) / Chapter Skim
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5 Vaccine Injury
5 Vaccine Injury
Pages 65-84
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From page 65... ...
The second section consists of a review of scientific data on major adverse reactions to commonly used domestic vaccines for children and adults. Chapter 6 examines the legal ramifications of vaccine injury and compensation issues, and the effect of the current state of the law on vaccine production and innovation.
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From page 66... ...
Use of licensed vaccines is guided by the recommendations of several groups, including the Immunization Practices Advisory Committee of the CDC, the Committee on Infectious Diseases of the American Academy of Pediatrics, and the American College of Physicians. Their recommendations generally attempt to identify two groups: those who would benefit from immunization with a specific vaccine and those for whom vaccination Is contraindicated because of increased risk of possible adverse reactions.
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From page 67... ...
For example, if a study involved 300,000 individuals receiving a given immunization and if it were found that eight developed serious reactions (of a type that did not occur in the unvaccinated control population) , the reaction rate would be estimated to be approximately 27 per million doses.
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From page 68... ...
The appearance of one of these conditions shortly after vaccination may be misinterpreted as a cause-and-effect situation, difficult to prove or disprove in an individual case. Many of the alleged severe injuries from pertussis vaccine, such as infantile spasms, have not been found to be caused by the vaccine, temporal associations notwithstanding.4'5 This distinction between temporal association and causation may not be grasped readily by lay jurors and others who are unaccustomed to dealing with the concept, and most explanations are based on complex epidemiology that is even more difficult to comprehend.
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From page 69... ...
More severe local reactions occur occasionally, with considerable swelling and redness at the site of injection, sometimes followed by a ~knot" in the subcutaneous tissue that may persist for weeks. Rarely, a sterile abscess occurs.
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From page 70... ...
should be employed.l°,ll Recently, the Surgeon General's Immunization Practices Advisory Committee (ACIP) has recommended delaying the initiation or continuation of DTP immunization in children with symptoms of underlying neurological disease until those symptoms have been clarified.12 Severe neurological disease, the third type of alleged untoward event following DTP, has been the subject of many reports, mostly anecdotal and uncontrolled.13 These reports describe an acute encephalopathy with convulsions and coma, often resulting in severe, permanent intellectual and neurological impairment.
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From page 71... ...
Occasional temporal associations between the administration of DTP and the appearance of infantile spasms led to the concern that the two might be related. The NCES data clearly indicate that DTP does not cause infantile spasms; instead, overt manifestations of infantile spasms may be recognized 1 to 3 weeks earlier than usual because irritability and other minor symptoms secondary to the DTP attract attention to the child's preexisting neurological condition.4 Another problem of major importance is whether DTP might, in some
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From page 72... ...
Causative relationships have not been established, however, and it is likely that any apparent temporal associations are coincidental and can be explained by background rates of these conditions at the age when vaccinations are initiated. Diphtheria Toxoid Active immunization against diphtheria is accomplished with diphtheria toxoid, an inactivated toxin that retains immunizing potential.
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From page 73... ...
No doubt, both diphtheria and tetanus toxoids contribute to these types of reactions to DTP. In the past, however, less refined diphtheria toxoid preparations were responsible for more severe local and systemic reactions, presumably hypersensitive in nature.
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From page 74... ...
of major importance is the fact that surveillance of untoward events following immunization with the newer IPV has been insufficient to determine the potential incidence of rare but disabling sequelae following its administration. Measles Vaccine The measles vaccine contains live, attenuated measles virus and is usually administered in combination with rubella and mumps vaccines (MMR)
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From page 75... ...
The measles vaccine virus is grown in chick embryo culture, and traces of egg protein may be present in the vaccine. In the past, these minute amounts of egg protein were considered insufficient to cause allergic reactions, but recent reports have indicated that extremely rare anaphylactic-type reactions do occur, almost always in individuals with a strong history of similar reactions following the ingestion of eggs.31 A history of such reactions is now considered a contraindication to the administration of measles vaccine.
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From page 76... ...
All of these pregnancies resulted in normal infants, including two pairs of twins, without signs of the congenital rubella syndrome.35 This study indicates that the syndrome, if it ever occurs from the vaccine, does so at a far lower rate than that observed following natural disease. (Estimation of confidence limits indicates 95 percent probability that the rate of the syndrome following immunization is no more than 1.7 percent, if it occurs at all.)
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From page 77... ...
Recently, however, it has been recognized that rare instances of persistent or recurrent arthropathy occur following rubella vaccine or the natural disease. Although some of these may represent temporal association of other joint conditions with rubella disease or receipt of rubella vaccine, it appears that at least some may be attributable to the infection or vaccine.37 The vast majority of cases apparently caused by the vaccine or illness have been reported in young adult women, which may be due in part to the fact that adult males may be less likely to receive the vaccine.
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From page 78... ...
No prior association between influenza vaccines and this syndrome had been recognized, and careful monitoring of recipients of influenza vaccine subsequently has demonstrated no excess of this disease in association with other influenza vaccines.41 Why this sequela was unique to the swine flu vaccine is unknown. The incidence of Guillain-Barre syndrome peaked 2 to 3 weeks following administration of the swine flu vaccine.42 The precise incidence rate of the disease following the vaccine has been difficult to determine, however, because the syndrome occurs at low rates for other and unknown reasons throughout the year and, particularly for cases that occurred 6 or more weeks following vaccine administration, attribution of the disease to the vaccine has been difficult.
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From page 79... ...
From the mid-1950s until 1980, killed rabies vaccine was prepared in embryonated duck eggs; this vaccine, though far safer than the former preparation, resulted in undesirable rates of severe allergic reactions.47 Since 1980, the vaccine of choice in the United States has been an inactivated vaccine prepared in human cell tissue culture; approximately 100,000 persons have received a total of about 400,000 doses.48 Reactivity is low in most persons. However, approximately 1 per 1,000 vaccinees has exhibited a systemic allergic reaction, usually of the serum sickness type and most often occurring with the fifth (booster)
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From page 80... ...
Adverse events following immunization are reported to the FDA by manufacturers, pharmacists, physicians, and the military, and to the CDC by the parents or guardians of children who receive federally funded vaccines. Although these reporting systems are useful, neither of them provides an adequate basis for estimation of the total number of events that occur, in part because reporting is voluntary.
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From page 81... ...
1985. Adverse events following immunization.
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From page 82... ...
1983. Possible temporal association between diphtheria-tetanus toxoid-pertussis vaccination and sudden infant death syndrome.
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From page 83... ...
1984. Systemic allergic reactions following i~rununization with human diploid cell rabies vaccine.
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From page 84... ...
1984. Unpublished data presented to the Surgeon General's Immunization Practices Advisory Committee (ACIP)
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