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Seasonal influenza vaccine and Guillain-Barré syndrome: A self-controlled case series study
Clémence Grave1, Pauline Boucheron2, Jérémie Rudant2
1From the Department of Studies in Public Health (C.G., P.B., J.R., J.C., A.W.), French National Health Insurance, Paris; Assistance Publique-Hôpitaux de Paris (Y.M.), Unité de Rééducation Neurologique Infantile, Hôpital Bicêtre; CESP, Faculté de Médecine-Université Paris-Sud (Y.M.), Faculté de Médecine-UVSQ, INSERM, Université Paris-Saclay, Villejuif; Biostatistics and Pharmacoepidemiology (P.T.-B., S.E.), Inserm U1181 (B2PHI), UVSQ, University Paris Saclay, Institut Pasteur; and Laboratoire Modélisation (M.N.H.), Epidémiologie et Surveillance des Risques Sanitaires, Conservatoire National des Arts et Métiers, Paris, France. grave.clemence@gmail.com.
Objective:
To evaluate the risk of Guillain-Barré syndrome (GBS) following seasonal influenza vaccination based on French nationwide data.
Methods:
All cases of GBS occurring in metropolitan France between September 1 and March 31 from 2010 to 2014 were identified from the French national health data system. Data were analyzed according to the self-controlled case series method. The risk period started 1 day after the patient received vaccine (D1) until 42 days after vaccination (D42). The incidence of GBS during this risk period was compared to that of the control period (D43-March 31). The incidence rate ratio (IRR) was estimated after adjusting for seasonality and presence or not of acute infections.
Results:
Between September and March, of the 2010/2011 to 2013/2014 influenza vaccination seasons, 3,523 cases of GBS occurred in metropolitan France and were included in the study. Among them, 15% (527 patients) had received influenza vaccination. A total of 140 patients developed GBS during the 42 days following influenza vaccination. The crude risk of developing GBS was not significantly increased during the 42 days following influenza vaccination (IRR, 1.02; 95% confidence interval [CI], 0.83-1.25; p = 0.85). This result remained nonsignificant after adjustment for calendar months and the incidence of acute gastrointestinal and respiratory tract infections (IRR, 1.10; 95% CI, 0.89-1.37; p = 0.38). In contrast, the risk of GBS was fourfold higher after acute respiratory tract infection (IRR, 3.89; 95% CI, 3.52-4.30; p < 0.0001) or gastrointestinal infection (IRR, 3.64; 95% CI, 3.01-4.40; p < 0.0001).
Conclusions:
No association between seasonal influenza vaccination and GBS was shown during the 42 days following vaccination.
