Risk of Guillain-Barré Syndrome Following COVID-19 Vaccines: A Nationwide Self-Controlled Case Series Study.

Autor:	Le Vu S; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France. stephane.le-vu@ansm.sante.fr., Bertrand M; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France., Botton J; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France., Jabagi MJ; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France., Drouin J; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France., Semenzato L; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France., Weill A; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France., Dray-Spira R; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France., Zureik M; From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Jazyk:	angličtina
Zdroj:	Neurology [Neurology] 2023 Nov 21; Vol. 101 (21), pp. e2094-e2102. Date of Electronic Publication: 2023 Oct 03.
DOI:	10.1212/WNL.0000000000207847
Abstrakt:	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. (© 2023 American Academy of Neurology.)
Databáze:	MEDLINE
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