DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis

EXECUTIVE SUMMARY

An Institute of Medicine (IOM) committee recently concluded that the evidence is consistent with a causal relation between vaccination with DPT and acute encephalopathy (IOM, 1991), and the excess risk was estimated to range from 0 to 10.5 per million DPT immunizations. However, the same IOM committee also concluded that the evidence was insufficient to indicate a causal relation between DPT and permanent neurologic damage (IOM, 1991). In fact, the relation between DPT and chronic nervous system dysfunction had not been studied in a rigorous scientific manner until recently. Because the evidence has been so limited, the appearance of a single new report, a 10-year follow-up to the National Childhood Encephalopathy Study (NCES; Miller et al., 1993), prompted the U.S. Public Health Service to ask IOM to convene the Committee to Study New Research on Vaccines with the charge of studying the new data and, if warranted, reevaluating the causal relation between DPT and chronic nervous system dysfunction.

The NCES reported that the occurrence of hospitalization for serious neurologic disorders among 2- to 35-month-old children is very strongly related to the occurrence of death or nervous system dysfunction (neurologic, behavioral, educational, motor, sensory, or self-care impairment) up to age 10 years (Madge et al., 1993; Miller et al., 1993). Children who experienced the rare but serious acute neurologic disorder within 7 days after receiving DPT were no more or less likely to experience documented chronic nervous system dysfunction or to have died within 10 years of the acute disorder than children who had not received DPT within 7 days prior to the onset of the disorder. There were no special characteristics associated with the acute or chronic nervous system illnesses linked to DPT exposure.



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DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis EXECUTIVE SUMMARY An Institute of Medicine (IOM) committee recently concluded that the evidence is consistent with a causal relation between vaccination with DPT and acute encephalopathy (IOM, 1991), and the excess risk was estimated to range from 0 to 10.5 per million DPT immunizations. However, the same IOM committee also concluded that the evidence was insufficient to indicate a causal relation between DPT and permanent neurologic damage (IOM, 1991). In fact, the relation between DPT and chronic nervous system dysfunction had not been studied in a rigorous scientific manner until recently. Because the evidence has been so limited, the appearance of a single new report, a 10-year follow-up to the National Childhood Encephalopathy Study (NCES; Miller et al., 1993), prompted the U.S. Public Health Service to ask IOM to convene the Committee to Study New Research on Vaccines with the charge of studying the new data and, if warranted, reevaluating the causal relation between DPT and chronic nervous system dysfunction. The NCES reported that the occurrence of hospitalization for serious neurologic disorders among 2- to 35-month-old children is very strongly related to the occurrence of death or nervous system dysfunction (neurologic, behavioral, educational, motor, sensory, or self-care impairment) up to age 10 years (Madge et al., 1993; Miller et al., 1993). Children who experienced the rare but serious acute neurologic disorder within 7 days after receiving DPT were no more or less likely to experience documented chronic nervous system dysfunction or to have died within 10 years of the acute disorder than children who had not received DPT within 7 days prior to the onset of the disorder. There were no special characteristics associated with the acute or chronic nervous system illnesses linked to DPT exposure.

OCR for page 1
DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis The NCES did not investigate the possibility of a direct relation between DPT and chronic nervous system dysfunction, that is, in the absence of a serious acute neurologic illness that occurs within 7 days after receiving DPT. The NCES provides data only on the limited case of a possible relation between DPT and chronic nervous system dysfunction in those children in whom a serious acute neurologic illness followed DPT vaccination within 7 days. The committee posits three plausible scenarios whereby the acute neurologic illnesses that follow DPT might be related to chronic nervous system dysfunction. DPT administration might cause serious acute neurologic illness and subsequent chronic dysfunction in children who otherwise might not have experienced either an acute neurologic illness or chronic dysfunction in the absence of DPT. DPT might trigger (and thereby be an immediate or proximate cause) an acute neurologic illness and subsequent chronic dysfunction in children with underlying brain or metabolic abnormalities. Such children might experience acute neurologic illness and subsequent chronic dysfunction in association with some trigger other than DPT. DPT might cause an acute neurologic illness in children with underlying brain or metabolic abnormalities that would themselves eventually have led to chronic dysfunction even in the absence of an acute neurologic illness. The committee believes its conclusions take into account the fact that the data do not support any one of these scenarios over the others. Because the NCES did not (and probably could not) rule out the possibility that only children with underlying brain or metabolic abnormalities react to stimuli such as DPT with acute neurologic illness, and no other studies establish or rule out such a possibility, the committee concludes that the evidence is insufficient to indicate whether or not DPT increases the overall risk in children of chronic nervous system dysfunction. The NCES data are consistent with the possibility that some children without underlying brain or metabolic abnormalities might experience serious acute neurologic illness within 7 days after receiving DPT and that acute neurologic illness will have chronic nervous system sequelae. The NCES data also are consistent with the possibility that some children with underlying brain or metabolic abnormalities (which foster a “triggering” by DPT of an acute neurologic illness) might go on to develop chronic nervous system dysfunction due to a DPT-triggered acute illness. Therefore, the committee concludes that the balance of evidence is consistent with a causal relation between DPT and the forms of chronic nervous system dysfunction described in the NCES in those children who experience a serious acute neurologic illness within 7 days after