Adverse Effects of Pertussis and Rubella Vaccines (1991) / Chapter Skim
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5 Evidence Concerning Pertussis Vaccinces and Deaths Classified as Sudden Infant Death Syndrome (SIDS)
5 Evidence Concerning Pertussis Vaccinces and Deaths Classified as Sudden Infant Death Syndrome (SIDS)
Pages 125-143
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From page 125... ...
18~. The postmortem examination to be performed was specified to include gross examination of the thorax, abdomen, brain, and larynx; histologic examination of the brain, heart, lungs, liver, kidney, and any other organs suspected to be involved by either history or macroscopic findings; and any additional studies (e.g., cultures and toxicology)
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From page 126... ...
A number of investigators have reported seasonal variations in SIDS mortality rates, with a relative increase in frequency in winter months (Golding et al., 1985~. Predictors of SIDS include individual characteristics (male sex, low birth weight, multiple births, and black race)
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From page 127... ...
~ffec.t of rlelavin~ immunization dur AA~1 TV ~^ ~_~^ r~ _ ~ ~ -I ~ ing such illnesses would be to produce a spuriously low rate of SIDS in the immediate postimmunization period. Thus, in addition to age and possible delaying factors, the potential role of minor illnesses in the timing of immunization is important to address in evaluating the studies of SIDS and DPT vaccine administration.
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From page 128... ...
EVIDENCE FROM STUDIES IN HUMANS Case Reports and Case Series In addition to those just cited, case reports of SIDS include the deaths of 5- and 10-month-old twins within 3 and 24 hours, respectively, of DPT immunization (Roberts, 1987; Werne and Garrow, 19461. Episodes of death following administration of DPT vaccine were reported for six additional children, five of whom died within 48 hours of immunization (Courter and Fisher, 19851.
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From page 129... ...
The authors assumed that cases should have occurred with uniform frequency throughout the 28 days following immunization, but noted instead a significant increase in the frequencies of reported cases in both the first day and the first week following DPT vaccination. These investigators also noted a similar clustering of cases of SIDS following physician visits that did not include DPT immunization, a finding that suggests that the prior assumption of uniform frequency was incorrect.
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From page 130... ...
For the reasons discussed above, reports of single or multiple cases of death within hours, days, or weeks of DPT administration offer limited insight into the possibility of a causal connection between this immunization and the occurrence of SIDS. Therefore, it is important to consider the reports of controlled studies of SIDS, in which the questions of an increased risk in the early postimmunization period can be addressed more adequately.
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From page 131... ...
in the DT group, at 2, 5, 37, and 40 days. Treating the children who received DT as a control group, the relative risk of SIDS is 0.6, with a 95 percent confidence interval of 0.1 to 2.3.i Although this finding indicates an inverse association between DPT vaccine and SIDS, the relative risk is not significantly below 1.0.
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From page 132... ...
et al., 1989 case-control registered deaths in France over 3 months in children ages 85 to 365 days in which physician responded to a questionnaire aRR (95% CI) , Estimated relative risk (95 percent confidence interval)
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From page 133... ...
1.2 1.2 low -birth-weight matched 29 healthy 262 healthy at 79 95 0.2 (0.05-0.4) 2.9 4.7 at birth with birth with birth birth weight weight of 22,500 g, 22,500 g random sample age and period-matched (to generate expected number of cases)
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From page 134... ...
Same Walker et Matched 1972-1983 26,500 Members of Group 23 healthy at al., 1987 case-cohort Health Cooperative, birth with birth Puget Sound weight 22,500 g Griffin et Cohort 1974-1984 129,834 Children born in 109 al., 1988 Tennessee and immunized at four county public health clinics aRR (95% CI) , Estimated relative risk (95 percent confidence interval)
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From page 135... ...
3.0 4.8 2. 403 age-, race-, low-birth-weight matched 262 healthy at birth with birth weight of 22,500 g, random sample ageand period-matched (to generate expected number of cases)
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From page 136... ...
The odds ratio for the risk of SIDS is 0.5 with a 95 percent confidence interval from 0.4 to 0.7 with the first control group and 0.6 with a confidence interval from 0.5 to 0.7 with the second control group. This study also has high power; an increased odds ratio of only 1.6 with the first control group and 1.25 with the second control group would have an 80 percent chance of being detected with a sample of this size; the comparable figures for 50 percent power are 1.4 and 1.2.2 After adjustment for 11 other potential risk factors for SIDS, including maternal age, education, cigarette smoking, and infant low birth weight, the odds ratios were 0.7 for vaccinees versus each of the control groups.
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From page 137... ...
A1though this ratio is based on only four cases of SIDS in the O to 3 days following immunization, the relative risk is significantly increased (the 95 percent confidence interval runs from 1.7 to 31.04. No non-SIDS death occurred in close temporal proximity to an immunization (Walker, 1990~.
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From page 138... ...
The estimated relative risks (and 95 percent confidence intervals) for these comparisons were 1.6 (1.0 to 2.5)
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From page 139... ...
None of the calculations, however, leads to a significantly increased risk of SIDS in the early postimmunization period. Indeed, if only the well-controlled studies are 10 my In ._ - 1 cog i_ in 0.1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 A&B B O Fixed A&B B O A&B B O Random All Studies Fixed Well-controlled Studies A&B B O Random FIGURE 5-1 Meta-analysis results comparing the estimated risk of SIDS in the early period postvaccination with that in the late part of the first month, under various assumptions: (1)
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From page 140... ...
The meta-analysis results give a rough sense of the power of the pooled data to detect elevated relative risk estimates. The ratio of the upper confidence interval to the average estimated relative risk in the meta-analysis results (Figure 5-1)
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From page 141... ...
A meta-analysis of the data on timing of SIDS deaths relative to DPT immunization shows that, although the specific numerical estimates of the relative risk of SIDS depend to some extent on the analytic assumptions that were made (see preceding section and Appendix D) , there is no indication of a statistically significant increased risk of SIDS in the early postimmunization period.
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From page 142... ...
1987. Diphtheria-tetanus-pertussis immunization and sudden infant death: results of the National Institute of Child Health and Human Development Cooperative Epidemiological Study of Sudden Infant Death Syndrome Risk Factors.
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From page 143... ...
1985. DPT vaccination, visit to child health center and sudden infant death syndrome (SIDS)
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