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ABSTRACT
Objectives. This study examined whether there is a risk that tetanustoxoid-containing vaccines could cause Gui(lain-Barre syndrome and, if so, how large the risk is.
Methods. This study was based on previous active surveillance epidemiological studies of GuillainBarre syndrome and vaccination history.
Results. A background rate of 0.3 cases of Guillain-Barre syndrome per million person-weeks has been estimated. By chance, 2.2 people with the syndrome would have received tetanus-toxoidcontaining vaccine within the 6 weeks before onset, yet only 1 person had done so. Data on children show similar results.
Conclusions. If an association exists, it must be extremely rare and not of public health significance. (Am J Public Health. 1997;87: 2045-2048)
Introduction
The National Childhood Vaccine Injury Act of 1986 mandated that the US government conduct a scientific review of the possible adverse consequences of all childhood vaccines.1 The Vaccine Safety Committee of the Institute of Medicine published its conclusions about adverse reactions of pertussis and rubella vaccines in 19912 and about the other childhood vaccines in 1993.3 In the 1993 report, the Institute of Medicine concluded that "the evidence favored acceptance of a causal relation between tetanus toxoid (and therefore tetanus-toxoid-containing vaccines (TTCV)) and Guillain-Barre syndrome (GBS)."3 This conclusion was based on biological plausibility and a striking case report, from 1978, of a 42-year-old man who received tetanus toxoid on three occasions during a 13-year period and developed a self-limited episode of Guillain-Barre syndrome after each vaccination. This man also experienced multiple subsequent episodes of Guillain-Barre syndrome following acute viral illnesses. Several other case reports of Guillain-Barre syndrome following tetanus-toxoid-containing vaccines among adult patients exist, as does a single report of Guillain-Barre syndrome following diptheria, tetanus, and pertussis (DTP) vaccination in a child with exacerbation following tetanus-diptheria (Td) vaccination as an adolescent (National Vaccine Injury Compensation Program, Geoffrey Evans, MD, oral communication), but these reports do not establish causality. Because no controlled studies were done, however, the Institute of Medicine was unable to quantify the magnitude of this potential risk.
Over 36 million doses of tetanustoxoid-containing vaccines are administered to children and adults annually as DTP, diptheria-tetanus (DT) and Td, and tetanus vaccine.4 It is therefore important to estimate the risk of Guillain-Barre syndrome after administration of tetanustoxoid-containing vaccines.
In this study,...