Department of Neurology, Seoul Hospital, Ewha Womans University College of Medicine, Seoul, South Korea.
Department of Neurology, Seoul National University Hospital, Seoul, South Korea.
J Peripher Nerv Syst. 2022 Sep;27(3):206-214. doi: 10.1111/jns.12507. Epub 2022 Jul 6.
Vaccinations against the severe acute respiratory syndrome coronavirus 2 which causes COVID-19 have been administered worldwide. We aimed to investigate associations of COVID-19 vaccination with the occurrence of Guillain-Barré syndrome (GBS). We explored potential safety signals regarding the development of GBS using disproportionality analyses to compare COVID-19 vaccination with all adverse drug reaction (ADR) reports and influenza vaccines reported to VigiBase. As of October 15, 2021, a total of 2163 cases (0.13%) of GBS and its variants (including 46 cases of Miller-Fisher syndrome and 13 cases of Bickerstaff's encephalitis) were identified in entire ADR database after vaccination with the ChAdOx1 nCoV-19 (AstraZeneca, Cambridge, UK) or the two messenger RNA-based COVID-19 (BNT162b2; Pfizer and BioNTech) or mRNA-1273; Moderna) vaccines. The median time to onset of GBS after vaccination was around 2 weeks. The ChAdOx1 nCoV-19 and two messenger RNA-based COVID-19 vaccines demonstrated a higher risk for GBS against entire database (information component [IC] = 1.73 reporting odds ratio [ROR] = 3.51; IC = 1.07, ROR = 2.22, respectively). When compared with influenza vaccines, neither the ChAdOx1 nCoV-19 nor mRNA-based vaccines were found to be associated with greater risks of GBS (IC = -1.84, ROR = 0.11; IC = -1.86, ROR = 0.06, respectively). Although potential safety signals associated with GBS COVID-19 vaccines have been identified, the risk of GBS from COVID-19 vaccines were low and did not surpass those of influenza vaccines; however, because of the heterogeneity of the sources of information in the WHO pharmacovigilance database, further epidemiological studies are warranted to confirm these observations.
针对导致 COVID-19 的严重急性呼吸系统综合征冠状病毒 2 的疫苗已在全球范围内接种。我们旨在研究 COVID-19 疫苗接种与吉兰-巴雷综合征(GBS)发生之间的关联。我们通过不比例分析来探索 GBS 发展的潜在安全信号,以比较 COVID-19 疫苗接种与向 VigiBase 报告的所有药物不良反应(ADR)报告和流感疫苗。截至 2021 年 10 月 15 日,在接种 ChAdOx1 nCoV-19(阿斯利康,英国剑桥)或两种基于信使 RNA 的 COVID-19(BNT162b2;辉瑞和 BioNTech)或 mRNA-1273 后,整个 ADR 数据库中总共发现了 2163 例(0.13%)GBS 及其变体(包括 46 例 Miller-Fisher 综合征和 13 例 Bickerstaff 脑炎)疫苗。接种疫苗后 GBS 的中位发病时间约为 2 周。ChAdOx1 nCoV-19 和两种基于信使 RNA 的 COVID-19 疫苗对整个数据库的 GBS 风险更高(信息成分 [IC] = 1.73 报告比值比 [ROR] = 3.51;IC = 1.07,ROR = 2.22,分别)。与流感疫苗相比,ChAdOx1 nCoV-19 和基于 mRNA 的疫苗均未发现与 GBS 风险增加相关(IC = -1.84,ROR = 0.11;IC = -1.86,ROR = 0.06,分别)。尽管已经确定了与 COVID-19 疫苗相关的 GBS 潜在安全信号,但 COVID-19 疫苗的 GBS 风险较低,并未超过流感疫苗;然而,由于世界卫生组织药物警戒数据库中信息来源的异质性,需要进一步的流行病学研究来证实这些观察结果。