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American Journal of Epidemiology Vol. 133, No. 9: 940-951
Copyright © 1991 by The Johns Hopkins University School of Hygiene and Public Health
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Reassessment of the Association between Guillain-Barré Syndrome and Receipt of Swine Influenza Vaccine in 1976–1977: Results of a Two-State Study
1 Hospital Infections Program, Center for Infectious Diseases, Centers for Disease Control Atlanta, GA
2 Division of Immunologic, Oncologic, and Hematologic Diseases, Center for Infectious Diseases, Centers for Disease Control Atlanta, GA
3 Department of Health Sciences Research, Mayo Clinic and Foundation Rochester, MN
4 Department of Neurosciences, School of Medicine, University of California San Diego, CA
5 Bureau of Laboratory and Epidenruologic Services, Michigan Department of Public Health Lansing, MI
6 Acute Disease Epidemalogy Section, Minnesota Department of Health Minneapolis, MN
Reprint requests to Dr James M Hughes, Center for Infectious Diseases, Centers for Disease Control, C12, 1600 Clifton Road. N E. Atlanta. GA 30333
Although the original Centers for Disease Control study of the relation between A/ New Jersey/8/76 (swine flu) vaccine and Guillain-Barré syndrome (polyradiculoneuritis) demonstrated a statistical association and suggested a causal relation between the two events, controversy has persisted. To reassess this association, the authors obtained medical records of all previously reported adult patients with Guillain-Barré syndrome in Michigan and Minnesota from October 1, 1976 through January 31, 1977. To identify previously unreported hospitalized cases with onset of symptoms during this period, the authors surveyed medical care facilities. A group of expert neurologists formulated diagnostic criteria for Guillain-Barré syndrome and then reviewed the clinical records in a blinded fashion. Of the 98 adult patents from the original Centers for Disease Control study eligible for consideration, three were found to have been misclassified by date of onset and were excluded. Of the remaining 95, the 28 (29%) who did not meet the diagnostic criteria were equally distributed between the vaccinated group (18 of 60, 30%) and the unvaccinated group (10 of 35, 29%). In addition to the 67 remaining cases who met the diagnostic criteria, six previously unreported cases (three of whom had been vaccinated) were found and included in this analysis. The relative nsk of developing Guillain-Barre syndrome in the vaccinated population of these two states dunng the 6 weeks following vaccination was 7.10, comparable to the relative nsk of 7.60 found in the onginal study. These findings suggest that there was an increased risk of developing Guillain-Barré syndrome dunng the 6 weeks following vaccination in adults. The excess cases of Guillain-Barré syndrome dunng the first 6 weeks attributed to the vaccine was 8.6 per million vaccinees in Michigan and 9.7 per million vaccines in Minnesota No increase in relative nsk for Guillain-Barrié syndrome was noted beyond 6 weeks after vaccination. Am J Epidemiol 1991; 133: 940–51
immunization; influenza; polyradiculoneuritis; vaccination; vaccines
7 The Expert Neurology Group responsible for casedefinitions and case-classification consisted of- Dr Wigbert C Wiederholt (chair), Dr Maunceo Victor, Veterans Administration Hospital, White River Junction, VT, Dr Donald W Mulder, Mayo Clinic, Rochester, MN, Dr Herbert R Karp, Emory University School of Median, Atlanta, GA, Dr James W Albers, University of Michigan Medical Center, Ann Arbor, MI, and Dr Arthur K Asbury, Hospital of the University of Pennsylvania, Phfladelphia, PA
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