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

被引:0
作者
Nasreen, Sharifa [1 ,2 ]
Jiang, Yannan [3 ,4 ]
Lu, Han [3 ,4 ]
Lee, Arier [3 ,4 ]
Cutland, Clare L. [5 ]
Gentile, Angela
Giglio, Norberto [6 ]
Macartney, Kristine [7 ]
Deng, Lucy [7 ]
Liu, Bette [7 ]
Sonneveld, Nicole [7 ]
Bellamyh, Karen [8 ]
Clothier, Hazel J. [4 ,9 ]
Kattand, Gonzalo Sepulveda [4 ,9 ]
Naus, Monika [10 ]
Naveed, Zaeema [10 ,11 ]
Janjua, Naveed Z. [10 ,11 ]
Nguyen, Lena
Hviid, Anders [12 ]
Poukka, Eero [13 ,14 ]
Perala, Jori [13 ]
Leino, Tuija [13 ]
Chandra, Lukman Ade [15 ]
At Thobari, Jarir [15 ]
Park, Byung-Joo [16 ]
Choi, Nam-Kyong [17 ]
Jeong, Na-Young [18 ]
Madhi, Shabir A. [19 ]
Villalobos, Felipe [20 ,21 ]
Solorzano, Martin [20 ,21 ,22 ]
Bissacco, Carlo Alberto [20 ,21 ]
Carreras-Martinezu, Juan Jose [21 ,23 ]
Correcher-Martinez, Elisa [21 ,23 ]
Urchueguia-Fornes, Arantxa [21 ,24 ]
Royuy, Debabrata [21 ,25 ]
Yeomans, Alison [21 ,25 ]
Aureliusu, Taylor [21 ,25 ]
Mortonu, Kathryn [21 ,25 ]
Di Mauro, Gianmarco [21 ,26 ]
Sturkenboom, Miriam C. J. M. [21 ]
Sejvar, James J. [27 ,28 ]
Top, Karina A. [29 ]
Batty, Karin [3 ,4 ]
Ghebreab, Luam [4 ]
Griffin, Jennifer B. [4 ]
Petousis-Harrisc, Helen [3 ,4 ]
Buttery, Jim [4 ,9 ]
Black, Steven [4 ]
Kwong, Jeffrey C. [1 ,30 ]
机构
[1] ICES, V1 06,2075 Bayview Ave, Toronto, ON M4N 3M5, Canada
[2] SUNY Downstate, Brooklyn, NY USA
[3] Univ Auckland, Auckland, New Zealand
[4] Global Coordinating Ctr, Global Vaccine Data Network, Auckland, New Zealand
[5] Univ Witwatersrand, Fac Hlth Sci, Sch Pathol, Wits African Leadership Vaccinol Expertise Wits Al, Johannesburg, South Africa
[6] Univ Buenos Aires, Inst Literatura Argentina Ricardo Rojas, Buenos Aires, DF, Argentina
[7] Natl Ctr Immunisat Res & Surveillance NCIRS, Westmead, NSW, Australia
[8] Monash Hlth, Dandenong, Vic, Australia
[9] Murdoch Childrens Res Inst, Bioinformat Unit, Parkville, Vic, Australia
[10] Univ British Columbia, Vancouver, BC, Canada
[11] British Columbia Ctr Dis Control, Vancouver, BC, Canada
[12] Statens Serum Inst, Dept Epidemiol Res, Copenhagen, Denmark
[13] Finnish Inst Hlth & Welf, Dept Publ Hlth, Helsinki, Finland
[14] Univ Helsinki, Fac Med, Dept Publ Hlth, Helsinki, Finland
[15] Gadjah Mada Univ, Ctr Epidemiol & Biostat Unit CEBU, Fac Med Publ Hlth & Nursing, Sleman Dist, Indonesia
[16] Natl Acad Med Korea, Seoul, South Korea
[17] Ewha Womans Univ, Coll Sci & Ind Convergence, Dept Hlth Convergence, Seoul, South Korea
[18] Ewha Womans Univ, Hlth Sci Convergence Res Inst, Seoul, South Korea
[19] Univ Witwatersrand, Fac Hlth Sci, South African Med Res Council, Vaccines & Infect Dis Analyt Unit, Johannesburg, South Africa
[20] Univ Barcelona, Observ Alimentacio ODELA, Barcelona, Spain
[21] Vaccine Monitoring Collaborat Europe VAC4EU, Utrecht, Netherlands
[22] Univ Med Ctr Utrecht, Dept Data Sci & Biostat, Utrecht, Netherlands
[23] Fdn Promot Hlth & Biomed Res Valencia Reg FISABIO, Valencia, Spain
[24] Inst Salud Carlos III, CIBER Epidemiol & Salud Publ, Madrid, Spain
[25] Drug Safety Res Unit DSRU, Southampton, Hants, England
[26] Teamit Inst, Barcelona, Spain
[27] Natl Ctr Emerging & Zoonot Infect Dis, CDCP, Div High Consequence Pathogens & Pathol, Atlanta, GA 30333 USA
[28] Univ Pittsburgh, Sch Med, Anesthesiol, Pittsburgh, PA USA
[29] Univ Alberta, Dept Pediat, Edmonton, AB, Canada
[30] ICES, V1 06, 2075 Bayview Ave, Toronto, ON M4N 3M5, Canada
关键词
Vaccine safety surveillance; Pharmacovigilance; Guillain-Barre<acute accent> syndrome; COVID-19; Self-controlled case series; INFLUENZA VACCINES;
D O I
10.1016/j.vaccine.2025.127291
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background: The association between Guillain-Barre<acute accent> 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 NetworkTM (GVDN (R)). 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.
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页数:11
相关论文
共 33 条
[1]   Is Guillain-Barre Syndrome Associated With COVID-19 Infection? A Systemic Review of the Evidence [J].
Abdullahi, Auwal ;
Candan, Sevim Acaroz ;
Soysal Tomruk, Melda ;
Elibol, Nuray ;
Dada, Olumide ;
Truijen, Steven ;
Saeys, Wim .
FRONTIERS IN NEUROLOGY, 2021, 11
[2]  
Aladawi M, 2021, Can J Neurol Sci / Journal Canadien des Sciences Neurologiques, V1, P11
[3]  
[Anonymous], 2021, COVID-19 Vaccine Janssen | European Medicines Agency
[4]   Validity-of hospital discharge diagnoses for public health surveillance of the Guillain-Barre syndrome [J].
Bogliun, G ;
Beghi, E .
NEUROLOGICAL SCIENCES, 2002, 23 (03) :113-117
[5]  
European Medicines Agency (EMA), 2021, COVID-19 Vaccine safety update for COVID19 Vaccine Janssen
[6]   COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals [J].
Faksova, K. ;
Walsh, D. ;
Jiang, Y. ;
Griffin, J. ;
Phillips, A. ;
Gentile, A. ;
Kwong, J. C. ;
Macartney, K. ;
Naus, M. ;
Grange, Z. ;
Escolano, S. ;
Sepulveda, G. ;
Shetty, A. ;
Pillsbury, A. ;
Sullivan, C. ;
Naveed, Z. ;
Janjua, N. Z. ;
Giglio, N. ;
Perala, J. ;
Nasreen, S. ;
Gidding, H. ;
Hovi, P. ;
Vo, T. ;
Cui, F. ;
Deng, L. ;
Cullen, L. ;
Artama, M. ;
Lu, H. ;
Clothier, H. J. ;
Batty, K. ;
Paynter, J. ;
Petousis-Harris, H. ;
Buttery, J. ;
Black, S. ;
Hviid, A. .
VACCINE, 2024, 42 (09) :2200-2211
[7]   RELATIVE INCIDENCE ESTIMATION FROM CASE SERIES FOR VACCINE SAFETY EVALUATION [J].
FARRINGTON, CP .
BIOMETRICS, 1995, 51 (01) :228-235
[8]   Baricitinib for COVID-19: a suitable treatment? [J].
Favalli, Ennio G. ;
Biggioggero, Martina ;
Maioli, Gabriella ;
Caporali, Roberto .
LANCET INFECTIOUS DISEASES, 2020, 20 (09) :1012-1013
[9]   Guillain-Barre syndrome and COVID-19: an observational multicentre study from two Italian hotspot regions [J].
Filosto, Massimiliano ;
Piccinelli, Stefano Cotti ;
Gazzina, Stefano ;
Foresti, Camillo ;
Frigeni, Barbara ;
Servalli, Maria Cristina ;
Sessa, Maria ;
Cosentino, Giuseppe ;
Marchioni, Enrico ;
Ravaglia, Sabrina ;
Briani, Chiara ;
Castellani, Francesca ;
Zara, Gabriella ;
Bianchi, Francesca ;
Del Carro, Ubaldo ;
Fazio, Raffaella ;
Filippi, Massimo ;
Magni, Eugenio ;
Natalini, Giuseppe ;
Palmerini, Francesco ;
Perotti, Anna Maria ;
Bellomo, Andrea ;
Osio, Maurizio ;
Scopelliti, Giuseppe ;
Carpo, Marinella ;
Rasera, Andrea ;
Squintani, Giovanna ;
Doneddu, Pietro Emiliano ;
Bertasi, Valeria ;
Cotelli, Maria Sofia ;
Bertolasi, Laura ;
Fabrizi, Gian Maria ;
Ferrari, Sergio ;
Ranieri, Federico ;
Caprioli, Francesca ;
Grappa, Elena ;
Broglio, Laura ;
De Maria, Giovanni ;
Leggio, Ugo ;
Poli, Loris ;
Rasulo, Frank ;
Latronico, Nicola ;
Nobile-Orazio, Eduardo ;
Padovani, Alessandro ;
Uncini, Antonino .
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY, 2021, 92 (07) :751-756
[10]  
Global Vaccine Data Network, 2023, About us