| Autor: |
Lehmann HC; Department of Neurology, Klinikum Leverkusen, Faculty of Medicine, University of Cologne and University Hospital Cologne, Cologne, Germany., Oberle D; Division of Safety of Biomedicines and Diagnostics, Paul-Ehrlich Institute, Federal Institute for Vaccines and Biomedicines, Langen, Germany., Keller-Stanislawski B; Division of Safety of Biomedicines and Diagnostics, Paul-Ehrlich Institute, Federal Institute for Vaccines and Biomedicines, Langen, Germany., Rieck T; Robert Koch Institute, Department of Infectious Disease Epidemiology, Berlin, Germany., Streit R; Division of Safety of Biomedicines and Diagnostics, Paul-Ehrlich Institute, Federal Institute for Vaccines and Biomedicines, Langen, Germany. |
| Abstrakt: |
BackgroundGuillain-Barré syndrome (GBS) has been associated with vaccination against COVID-19.AimWe aimed to compare clinical characteristics and analyse excess GBS cases following administration of different COVID-19 and influenza vaccines in Germany versus the expected numbers estimated from pre-pandemic background incidence rates.MethodsWe analysed safety surveillance data reported to the German national competent authority between 27 December 2020 and 31 August 2021. GBS cases were validated according to Brighton Collaboration (BC) criteria. We conducted observed vs expected (OvE) analyses on cases fulfilling BC criteria levels 1 to 4 for all four European Medicines Agency-approved COVID-19 vaccines and for influenza vaccines.ResultsA total of 214 GBS cases after COVID-19 vaccination had been reported, of whom 156 were eligible for further analysis. Standardised morbidity ratio estimates 3-42 days after vaccination were 0.34 (95% confidence interval (CI): 0.25-0.44) for Comirnaty, 0.38 (95% CI: 0.15-0.79) for Spikevax, 3.10 (95% CI: 2.44-3.88) for Vaxzevria, 4.16 (95% CI: 2.64-6.24) for COVID-19 Vaccine Janssen and 0.60 (95% CI: 0.35-0.94) for influenza vaccines. Bilateral facial paresis was reported in 19.7% and 26.1% of the 156 GBS cases following vaccination with Vaxzevria and COVID-19 Vaccine Janssen, respectively, and only in 6% of cases exposed to Comirnaty.ConclusionThree and four times more GBS cases than expected were reported after vaccination with Vaxzevria and COVID-19 Vaccine Janssen, respectively, therefore GBS might be an adverse event of vector-based vaccines. Bifacial paresis was more common in cases with GBS following vaccination with vector-based than mRNA COVID-19 vaccines. |
