Vaccines and the risk of Guillain-Barré syndrome: A French pharmacovigilance analysis

Marie Gligorov; Bénédicte Lebrun-Vignes; Kamel Masmoudi; Thierry Vial; Helga Junot; Valérie Pourcher; Sophie Demeret; Nicolas Weiss; Kevin Bihan

doi:10.1016/j.therap.2025.02.007

Vaccines and the risk of Guillain-Barré syndrome: A French pharmacovigilance analysis

Therapie. 2025 Mar 3:S0040-5957(25)00035-6. doi: 10.1016/j.therap.2025.02.007. Online ahead of print.

Authors

Marie Gligorov¹, Bénédicte Lebrun-Vignes², Kamel Masmoudi³, Thierry Vial⁴, Helga Junot⁵, Valérie Pourcher⁶, Sophie Demeret⁷, Nicolas Weiss⁸, Kevin Bihan⁹

Affiliations

¹ Département de pharmacologie, AP-HP, GHU Sorbonne université, centre régional de pharmacovigilance Pitié-Saint-Antoine, 75000 Paris, France.
² Département de pharmacologie, AP-HP, GHU Sorbonne université, centre régional de pharmacovigilance Pitié-Saint-Antoine, 75000 Paris, France; EA 7379 EpiDermE, université Paris Est Créteil, 94000 Créteil, France; Department of Pharmacovigilance, hôpital Pitié-Salpêtrière, AP-HP, 75000 Paris, France.
³ Département de pharmacologie, CHU d'Amiens, centre régional de Pharmacovigilance, 80000 Amiens, France.
⁴ Service hospitalo-universitaire de pharmacotoxicologie, Hospices civils de Lyon, centre régional de pharmacovigilance, 69000 Lyon, France.
⁵ Pharmacie à usage intérieure site HU Pitié-Salpêtrière-Charles-Foix, AP-HP, GHU Sorbonne Université, 75000 Paris, France.
⁶ Service de maladies infectieuses et tropicales, AP-HP, Sorbonne université, hôpital de la Pitié-Salpêtrière, Inserm, Institut Pierre-Louis d'épidémiologie et de santé publique, 75000 Paris, France.
⁷ Sorbonne université, AP-HP, hôpital de la Pitié-Salpêtrière, département de neurologie, unité de médecine intensive réanimation à orientation neurologique, Groupe de Recherche Clinique en RÉanimation et Soins intensifs du Patient en Insuffisance Respiratoire aiguË (GRC-RESPIRE) Sorbonne Université, 75000 Paris, France.
⁸ Sorbonne université, AP-HP, hôpital de la Pitié-Salpêtrière, département de neurologie, unité de médecine intensive réanimation à orientation neurologique, Groupe de Recherche Clinique en RÉanimation et Soins intensifs du Patient en Insuffisance Respiratoire aiguË (GRC-RESPIRE) Sorbonne Université, 75000 Paris, France; Brain Liver Pitié-Salpêtrière (BLIPS) Study Group, Inserm UMR_S 938, centre de recherche Saint-Antoine, maladies métaboliques, biliaires et fibro-inflammatoire du foie, Institute of Cardiometabolism and Nutrition (ICAN), 75000 Paris, France.
⁹ Département de pharmacologie, AP-HP, GHU Sorbonne université, centre régional de pharmacovigilance Pitié-Saint-Antoine, 75000 Paris, France. Electronic address: kevin.bihan@aphp.fr.

PMID: 40090811
DOI: 10.1016/j.therap.2025.02.007

Abstract

Aims: Guillain-Barré syndrome (GBS) is a rare autoimmune-mediated disease that can occur in a post-vaccination context. During the vaccination surveillance program of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, reports of GBS as a possible adverse effect (AE) of SARS-CoV-2 vaccines have been reported. Our aim was to describe post-vaccine reports of GBS whatever the vaccine used.

Methods: Data were obtained from the French pharmacovigilance database from inception (1 January 1985) to 1st March 2022. Reports were analyzed according to the French causality assessment method but only reports with a time to onset from the beginning of the treatment and the first symptoms occurrence of less than 4weeks were included in our analysis, in accordance to the chronological criteria of the Brighton criteria.

Results: Three hundred and seventy-five (375) reports of GBS according to these selection criteria were retained for analysis. The data indicate a higher proportion of men (59%), with a median age of 54years and a median time-to-onset after vaccination of 12days. Around 45% of the reports were recorded with SARS-CoV-2 vaccines of which 68% involved post-mRNA vaccines and more precisely 56% post-tozinameran.

Conclusion: This study suggests that Guillain-Barré syndrome may be a rare but potentially severe adverse event that can occur in the first few weeks after vaccination whatever its nature. Even if a vaccine was injected in the weeks preceding the first signs of GBS, it is essential to perform a complete etiological assessment (search for bacterial or viral infection, particularly Campylobacter jejuni, etc.) in order to rule out another cause before considering its role in the onset of GBS. Continued pharmacovigilance survey of marketed vaccines is necessary to update or even harmonize its SmPCs.

Keywords: Adverse drug reaction; Guillain-Barré syndrome; Pharmacovigilance; Vaccination; Vaccine safety; Vaccine-induced.