Real-World Data on the Incidence and Risk of Guillain-Barre Syndrome Following SARS-CoV-2 Vaccination; A Prospective Surveillance Study
Jongmok Ha1, Hyunwook Kang1, Taeeun Kyung1, Namoh Kim1, Dong Kyu Kim1, Hyeonjoon Kim1, Kihoon Bae1, Min Cheol Song1, Kwang June Lee1, Euiho Lee1, Suyeon Park2, Beom Seuk Hwang3, Kunhee Park1, Jin Myoung Seok4, Jinyoung Youn5
1Infectious Disease Control Center, Gyeonggi Provincial Government, 2Department of Biostatistics, Soonchunhyang University Seoul Hospital, 3Department of Applied Statistics, Chung-Ang University, 4Department of Neurology, Soonchunhyang University Cheonan Hospital, 5Department of Neurology, Samsung Medical Center
Objective:
To report the crude incidence rate of GBS following SARS-CoV-2 vaccination; evaluate how vaccine dose, mechanism, age, and sex may affect the risk of GBS following SARS-CoV-2 vaccination; and clinically compare head-to-head GBS cases following two major mechanisms of vaccines.
Background:
Increasing evidence suggests an association between SARS-CoV-2 vaccines and Guillain-Barré syndrome (GBS). Nevertheless, little is understood about the contributing risk factors and clinical characteristics of GBS post SARS-CoV-2 vaccination.
Design/Methods:
In this prospective surveillance study of 38,828,692 SARS-CoV-2 vaccine doses administered from February 2021 to March 2022 in the Gyeonggi Province, South Korea, 55 cases of GBS were reported post vaccination. We estimated the incidence rate of GBS per million doses and the incidence rate ratio for the vaccine dose, mechanism, age, and sex. Additionally, we compared the clinical characteristics of GBS following mRNA-based and viral vector-based vaccinations.
Results:
The overall incidence of GBS following SARS-CoV-2 vaccination was 1.42 per million doses. Viral vector-based vaccines were associated with a higher risk of GBS. Men were more likely to develop GBS than women. The third dose of vaccine was associated with a lower risk of developing GBS. Classic sensorimotor and pure motor subtypes were the predominant clinical subtypes, and demyelinating type was the predominant electrodiagnostic subtype. The initial dose of viral-vector based vaccine and later doses of mRNA-based vaccine were associated with GBS, respectively.
Conclusions:
GBS following SARS-CoV-2 vaccination may not be clinically distinct. However, physicians should pay close attention to the classic presentation of GBS in men receiving an initial dose of viral vector-based SARS-CoV-2 vaccines.