Reassessment of the Association between Guillain-Barré Syndrome and Receipt of Swine Influenza Vaccine in 1976–1977: Results of a Two-State Study

Abstract

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 patients 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 risk of developing Guillain-Barré syndrome in the vaccinated population of these two states during the 6 weeks following vaccination was 7.10, comparable to the relative risk of 7.60 found in the original study. These findings suggest that there was an increased risk of developing Guillain-Barré syndrome during the 6 weeks following vaccination in adults. The excess cases of Guillain-Barré syndrome during the first 6 weeks attributed to the vaccine was 8.6 per million vaccinees in Michigan and 9.7 per million vaccinees in Minnesota. No increase in relative risk for Guillain-Barré syndrome was noted beyond 6 weeks after vaccination.

Guillain Barré syndrome in a population less than 15 years old in Brazil

“…Others vaccine were linked to GBS but this had being merely on temporal association, only the link with rabies vaccines are not controversial. For the epidemics followed the swine flue influenza vaccine, there is a consensus of expert concluding that a small risk of developing GBS exist for up to 6 weeks after immunization 26 .…”

Characterization of Immunological Cross-Reactivity between Enterotoxigenic Escherichia coli Heat-Stable Toxin and Human Guanylin and Uroguanylin

“…After washing, the plate was incubated with 100 l anti-rabbit secondary antibody (dilution, 1:400) for 1 h at room temperature. The plate was then developed for approximately 30 min by using 100 l freshly prepared developing buffer (1 mg/ml para-nitrophenylphosphate (pNPP) in 9.7% [vol/vol] 30. The plates were then washed with PBS-T and incubated at room temperature for 1 h with 100 l anti-mouse secondary antibody diluted in PBS-T (ST:G8, 1:400; clones 29 and 30, 1:2,000).…”

“…Autoimmune adverse effects of vaccination have been identified for both influenza and measles-mumps-rubella (MMR) vaccines. The 1976-1977 vaccination campaign against influenza (with the A/New Jersey/8/76 swine flu vaccine) resulted in an increased risk of Guillain-Barré syndrome (29,30), and the currently used MMR vaccine has been reported to increase the risk of acquiring idiopathic-thrombocytopenic purpura (31,32). Molecular mimicry that causes cross-reactivity and potential autoimmune reactions is also a well-known challenge to the development of vaccines against group A streptococci (33, 34), and the U.S. Food and Drug Administration (FDA) now requires extensive in vitro and animal data showing an absence of cross-reactivity before sanctioning human trials (35).…”

Guillain–Barré syndrome and Fisher syndrome: Case definitions and guidelines for collection, analysis, and presentation of immunization safety data

“…Thus, biological significance of this finding remains unclear. Subsequent studies assessing risk of GBS following other formulations of influenza vaccine have failed to consistently demonstrate a more than marginal increased risk of GBS [46][47][48][49][50][51][52][53].…”