The evidence remains insufficient to indicate the presence or absence of a causal relation between DPT and chronic nervous system dysfunction under any other circumstances. That is, because the NCES is the only systematic study of chronic nervous system dysfunctions after DPT, the committee can only comment on the causal relation between DPT and those chronic nervous system dysfunctions under the conditions studied by the NCES. In particular, it should be noted that the chronic nervous system dysfunctions associated with DPT followed a serious acute neurologic illness that occurred in children within 7 days after receiving DPT.

REFERENCES

Alderslade R, Bellman MH, Rawson NSB, Ross EM, Miller DL. The National Childhood Encephalopathy Study: A report on 1000 cases of serious neurological disorders in infants and young children from the NCES research team. In: Department of Health and Social Security. Whooping Cough: Reports from the Committee on the Safety of Medicines and the Joint Committee on Vaccination and Immunisation. London: Her Majesty's Stationery Office; 1981.

Fine PEM, Chen RT. Confounding in studies of adverse reactions to vaccines. American Journal of Epidemiology 1992;136:121–135.

Gale JL, Thapa PB, Bobo JK, Wassilak SGF, Mendelman PM, Foy HM. Acute Oregon. In: Manclark CR, ed. Sixth International Symposium on Pertussis, Abstracts. DHHS Publication No. (FDA) 90-1162. Bethesda, MD: U.S. Public Health Service, U.S. Department of Health and Human Services; 1990.

Gale JL, Thapa PB, Wassilak SGF., Bobo JK, Mendelman PM, Foy HM. Risk of serious acute neurological illness after immunization with diphtheria-tetanus-pertussis vaccine. Journal of the American Medical Association 1994; 271:37-41.

Griffin MR, Ray WA, Mortimer EA, Fenichel GM, Schaffner W. Risk of seizures and encephalopathy after immunization with the diphtheria-tetanus-pertussis vaccine. Journal of the American Medical Association 1990;263:1641–1645.

Institute of Medicine. Howson CP, Howe CJ, Fineberg HV, eds. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press; 1991.

Institute of Medicine. Stratton KR, Howe CJ, Johnston RB, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: National Academy Press; 1994.

Madge N, Miller D, Ross E, Wadsworth J. The National Childhood Encephalopathy Study: A 10-year Followup. In: Manclark, CR. (ed.). Sixth International Symposium on Pertussis, Abstracts. DHHS Publication No. (FDA) 90-1162. Bethesda, MD: U.S. Public Health Service, U.S. Department of Health and Human Services; 1990.

Madge N, Diamond J, Miller D, Ross E, McManus C, Wadsworth J, Yule W. The National Childhood Encephalopathy Study: A 10-year follow-up. A report of the medical, social, behavioural and educational outcomes after serious, acute, neurological illness in early childhood. Developmental Medicine and Child



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DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis The evidence remains insufficient to indicate the presence or absence of a causal relation between DPT and chronic nervous system dysfunction under any other circumstances. That is, because the NCES is the only systematic study of chronic nervous system dysfunctions after DPT, the committee can only comment on the causal relation between DPT and those chronic nervous system dysfunctions under the conditions studied by the NCES. In particular, it should be noted that the chronic nervous system dysfunctions associated with DPT followed a serious acute neurologic illness that occurred in children within 7 days after receiving DPT. REFERENCES Alderslade R, Bellman MH, Rawson NSB, Ross EM, Miller DL. The National Childhood Encephalopathy Study: A report on 1000 cases of serious neurological disorders in infants and young children from the NCES research team. In: Department of Health and Social Security. Whooping Cough: Reports from the Committee on the Safety of Medicines and the Joint Committee on Vaccination and Immunisation. London: Her Majesty's Stationery Office; 1981. Fine PEM, Chen RT. Confounding in studies of adverse reactions to vaccines. American Journal of Epidemiology 1992;136:121–135. Gale JL, Thapa PB, Bobo JK, Wassilak SGF, Mendelman PM, Foy HM. Acute Oregon. In: Manclark CR, ed. Sixth International Symposium on Pertussis, Abstracts. DHHS Publication No. (FDA) 90-1162. Bethesda, MD: U.S. Public Health Service, U.S. Department of Health and Human Services; 1990. Gale JL, Thapa PB, Wassilak SGF., Bobo JK, Mendelman PM, Foy HM. Risk of serious acute neurological illness after immunization with diphtheria-tetanus-pertussis vaccine. Journal of the American Medical Association 1994; 271:37-41. Griffin MR, Ray WA, Mortimer EA, Fenichel GM, Schaffner W. Risk of seizures and encephalopathy after immunization with the diphtheria-tetanus-pertussis vaccine. Journal of the American Medical Association 1990;263:1641–1645. Institute of Medicine. Howson CP, Howe CJ, Fineberg HV, eds. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press; 1991. Institute of Medicine. Stratton KR, Howe CJ, Johnston RB, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, DC: National Academy Press; 1994. Madge N, Miller D, Ross E, Wadsworth J. The National Childhood Encephalopathy Study: A 10-year Followup. In: Manclark, CR. (ed.). Sixth International Symposium on Pertussis, Abstracts. DHHS Publication No. (FDA) 90-1162. Bethesda, MD: U.S. Public Health Service, U.S. Department of Health and Human Services; 1990. Madge N, Diamond J, Miller D, Ross E, McManus C, Wadsworth J, Yule W. The National Childhood Encephalopathy Study: A 10-year follow-up. A report of the medical, social, behavioural and educational outcomes after serious, acute, neurological illness in early childhood. Developmental Medicine and Child

OCR for page 16
DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis Neurology 1993;Supplement No. 68;35(7):1–118. Marcuse EK, Wentz KR. The NCES reconsidered: Summary of a 1989 workshop. Vaccine 1990; 8:531–535. Miller D, Wadsworth J, Diamond J, Ross E. Pertussis vaccine and whooping cough as risk factors in acute neurological illness and death in young children. In: Proceedings of the Fourth International Symposium on Pertussis, Geneva, 1984. Developments in Biological Standardization 1985;16:389–394. Miller DL, Ross EM, Alderslade R, Bellman MH, Rawson NSB. Pertussis immunisation and serious acute neurological illness in children. British Medical Journal 1981;282:1595–1599. Miller DL, Madge N, Diamond J, Wadsworth J, Ross E. Pertussis immunisation and serious acute neurological illnesses in children. British Medical Journal 1993; 307:1171–1176. Walker AM, Jick H, Perera DR, Knauss RA, Thompson RS. Neurologic events following diphtheria-tetanus-pertussis immunization . Pediatrics 1988;81:345–349.