Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-05-28 DOI:10.1016/j.vaccine.2025.127291

Sharifa Nasreen , Yannan Jiang , Han Lu , Arier Lee , Clare L. Cutland , Angela Gentile , Norberto Giglio , Kristine Macartney , Lucy Deng , Bette Liu , Nicole Sonneveld , Karen Bellamy , Hazel J. Clothier , Gonzalo Sepulveda Kattan , Monika Naus , Zaeema Naveed , Naveed Z. Janjua , Lena Nguyen , Anders Hviid , Eero Poukka , Jeffrey C. Kwong

{"title":"Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study","authors":"Sharifa Nasreen , Yannan Jiang , Han Lu , Arier Lee , Clare L. Cutland , Angela Gentile , Norberto Giglio , Kristine Macartney , Lucy Deng , Bette Liu , Nicole Sonneveld , Karen Bellamy , Hazel J. Clothier , Gonzalo Sepulveda Kattan , Monika Naus , Zaeema Naveed , Naveed Z. Janjua , Lena Nguyen , Anders Hviid , Eero Poukka , Jeffrey C. Kwong","doi":"10.1016/j.vaccine.2025.127291","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>The association between Guillain-Barré syndrome (GBS) and certain COVID-19 vaccines is inconclusive. We investigated the risk of GBS after COVID-19 vaccination or SARS-CoV-2 infection.</div></div><div><h3>Methods</h3><div>Using a common protocol, we conducted a self-controlled case series study from 1 December 2020 to 9 August 2023 at 20 global sites within the Global Vaccine Data Network™ (GVDN®). Brighton Collaboration case definition criteria were used to determine the level of certainty (LOC) of medical record-reviewed GBS cases at 15 sites. GBS cases following SARS-CoV-2 infection were identified from electronic data sources (EDS) from 11 sites. We estimated the relative incidence (RI) of GBS within 1–42 days following receipt of adenoviral vector, mRNA, or inactivated COVID-19 vaccines or SARS-CoV-2 infection using conditional Poisson regression models, controlling for seasonality. We used random effects meta-analysis to pool the estimates across sites.</div></div><div><h3>Results</h3><div>Of 410 medical record-reviewed post-vaccination GBS cases (out of 2086 EDS-identified cases), 49 were LOC 1 or 2, 187 were LOC 3 or 4, and 174 were LOC 5. These cases received a total of 794 doses of COVID-19 vaccines (160 [20 %] adenoviral vector vaccine doses, 556 [70 %] mRNA vaccine doses, 77 [10 %] inactivated vaccine doses, and 1 [0.1 %] protein-based vaccine dose) during the observation period. We observed an increased risk of confirmed (LOC 1–2) GBS after receiving ChAdOx1-S/nCoV-19 (Vaxzevria/Covishield) (RI = 3.10; 95 % confidence interval [CI], 1.12–8.62). Decreased risks of LOC 1–4 GBS were observed after receiving BNT162b2 (Comirnaty/Tozinameran) (RI = 0.48; 95 %CI, 0.27–0.85) and CoronaVac/Sinovac (RI = 0.04; 95 %CI, 0.00–0.61). For 489 EDS-identified GBS cases after SARS-CoV-2 infection, we found GBS risk to be increased (RI = 3.35; 95 %CI, 1.83–6.11).</div></div><div><h3>Conclusion</h3><div>In this large multinational study, we found increased risks of GBS within 42 days after Vaxzevria/Covishield vaccination or SARS-CoV-2 infection, and decreased risks after receiving Comirnaty/Tozinameran or CoronaVac/Sinovac COVID-19 vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127291"},"PeriodicalIF":4.5000,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vaccine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0264410X25005882","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

The association between Guillain-Barré syndrome (GBS) and certain COVID-19 vaccines is inconclusive. We investigated the risk of GBS after COVID-19 vaccination or SARS-CoV-2 infection.

Methods

Using a common protocol, we conducted a self-controlled case series study from 1 December 2020 to 9 August 2023 at 20 global sites within the Global Vaccine Data Network™ (GVDN®). Brighton Collaboration case definition criteria were used to determine the level of certainty (LOC) of medical record-reviewed GBS cases at 15 sites. GBS cases following SARS-CoV-2 infection were identified from electronic data sources (EDS) from 11 sites. We estimated the relative incidence (RI) of GBS within 1–42 days following receipt of adenoviral vector, mRNA, or inactivated COVID-19 vaccines or SARS-CoV-2 infection using conditional Poisson regression models, controlling for seasonality. We used random effects meta-analysis to pool the estimates across sites.

Results

Of 410 medical record-reviewed post-vaccination GBS cases (out of 2086 EDS-identified cases), 49 were LOC 1 or 2, 187 were LOC 3 or 4, and 174 were LOC 5. These cases received a total of 794 doses of COVID-19 vaccines (160 [20 %] adenoviral vector vaccine doses, 556 [70 %] mRNA vaccine doses, 77 [10 %] inactivated vaccine doses, and 1 [0.1 %] protein-based vaccine dose) during the observation period. We observed an increased risk of confirmed (LOC 1–2) GBS after receiving ChAdOx1-S/nCoV-19 (Vaxzevria/Covishield) (RI = 3.10; 95 % confidence interval [CI], 1.12–8.62). Decreased risks of LOC 1–4 GBS were observed after receiving BNT162b2 (Comirnaty/Tozinameran) (RI = 0.48; 95 %CI, 0.27–0.85) and CoronaVac/Sinovac (RI = 0.04; 95 %CI, 0.00–0.61). For 489 EDS-identified GBS cases after SARS-CoV-2 infection, we found GBS risk to be increased (RI = 3.35; 95 %CI, 1.83–6.11).

Conclusion

In this large multinational study, we found increased risks of GBS within 42 days after Vaxzevria/Covishield vaccination or SARS-CoV-2 infection, and decreased risks after receiving Comirnaty/Tozinameran or CoronaVac/Sinovac COVID-19 vaccines.

查看原文本刊更多论文

COVID-19疫苗接种或SARS-CoV-2感染后发生格林-巴勒综合征的风险：一项多国自我对照病例系列研究

背景：格林-巴- 综合征（GBS）与某些COVID-19疫苗之间的关系尚无定论。我们调查了COVID-19疫苗接种或SARS-CoV-2感染后发生GBS的风险。方法采用通用方案，于2020年12月1日至2023年8月9日在全球疫苗数据网络™（GVDN®）内的20个全球站点进行了一项自控病例系列研究。使用Brighton协作病例定义标准来确定15个地点医疗记录审查的GBS病例的确定性水平（LOC）。从11个站点的电子数据源（EDS）中确定了SARS-CoV-2感染后的GBS病例。我们使用条件泊松回归模型估计了在接受腺病毒载体、mRNA或灭活COVID-19疫苗或SARS-CoV-2感染后1-42天内GBS的相对发病率（RI），并控制了季节性因素。我们使用随机效应荟萃分析来汇总各站点的估计。结果410例疫苗接种后GBS病例（2086例eds确诊病例）中，LOC 1、2型49例，LOC 3、4型187例，LOC 5型174例。这些病例在观察期内共接种了794剂新冠病毒疫苗（腺病毒载体疫苗160剂[20%]，mRNA疫苗556剂[70%]，灭活疫苗77剂[10%]，蛋白疫苗1剂[0.1%]）。我们观察到接受ChAdOx1-S/nCoV-19 （Vaxzevria/Covishield）后确诊（LOC 1-2） GBS的风险增加(RI = 3.10；95%置信区间[CI]， 1.12-8.62)。接受BNT162b2 （Comirnaty/Tozinameran）治疗后，LOC 1-4 GBS的风险降低(RI = 0.48；95% CI, 0.27-0.85)和CoronaVac/Sinovac (RI = 0.04；95% ci, 0.00-0.61)。在489例经eds鉴定的SARS-CoV-2感染后的GBS病例中，我们发现GBS风险增加(RI = 3.35；95% ci, 1.83-6.11)。结论在这项大型跨国研究中，我们发现接种Vaxzevria/Covishield疫苗或感染SARS-CoV-2后42天内GBS的风险增加，而接种Comirnaty/Tozinameran或CoronaVac/Sinovac COVID-19疫苗后风险降低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.