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Abstract
Background and Objectives Guillain-Barré syndrome (GBS) has been inconsistently associated with some coronavirus disease 2019 (COVID-19) vaccines. We aimed to quantify the risk of GBS according to the type of COVID-19 vaccine in a large population.
Methods Using the French National Health Data System linked to the COVID-19 vaccine database, we analyzed all individuals aged 12 years or older admitted for GBS from December 27, 2020, to May 20, 2022. We estimated the relative incidence (RI) of GBS within 1–42 days after vaccination up to the first booster dose compared with baseline periods using a self-controlled case series design. We then derived the number of cases attributable to the vaccination. Analyses were adjusted for the period and stratified by age group, sex, and for the presence of severe acute respiratory syndrome coronavirus 2 or common acute infections.
Results Of 58,530,770 people aged 12 years or older, 88.8% received at least 1 COVID-19 vaccine dose and 2,229 were hospitalized for GBS during the study period. Patients had a median age of 57 years, and 60% were male patients. The RI of GBS between 1–42 days was 2.5 (95% CI 1.8–3.6) for the first dose of ChAdOx1-S and 2.4 (95% CI 1.2–5.0) for the unique dose of Ad26.COV2.S vaccine. We estimated 6.5 attributable GBS cases per million persons having received a first dose of ChAdOx1-S and 5.7 cases per million for the Ad26.COV2.S vaccine. Except for the age group of 12–49 years after the second dose of the messenger RNA (mRNA)-1273 vaccine (RI 2.6, 95% CI 1.2–5.5), none of the RI estimates were found significantly increased for the mRNA vaccines.
Discussion In summary, we found increased risks of GBS after the first administration of ChAdOx1-S and Ad26.COV2.S vaccines. In this comprehensive assessment at the French population level, there was no statistically significant increase in the risk of GBS after the administration of mRNA vaccines. This is reassuring in the context of the ongoing and future use of mRNA-based booster vaccination.
Glossary
- AR=
- attributable risk;
- CNIL=
- Commission Nationale de l'Informatique et des Libertés;
- COVID-19=
- coronavirus disease 2019;
- FDR=
- false discovery rate;
- GBS=
- Guillain-Barré syndrome;
- mRNA=
- messenger RNA;
- RI=
- relative incidence;
- SARS-CoV-2=
- severe acute respiratory syndrome coronavirus 2;
- SCCS=
- self-controlled case series study;
- SNDS=
- French National Health Data System
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Submitted and externally peer reviewed. The handling editor was Associate Editor Anthony Amato, MD, FAAN.
CME Course: NPub.org/cmelist
- Received April 7, 2023.
- Accepted in final form August 3, 2023.
- © 2023 American Academy of Neurology
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