Incidence of Guillain–Barré syndrome following SARS‐CoV‐2 immunization: Analysis of a nationwide registry of recipients of 81 million doses of seven vaccines

• Published in: European journal of neurology Vol. 29; no. 11; pp. 3368 - 3379
• Main Authors: García‐Grimshaw, Miguel, Galnares‐Olalde, Javier Andrés, Bello‐Chavolla, Omar Yaxmehen, Michel‐Chávez, Anaclara, Cadena‐Fernández, Arturo, Briseño‐Godínez, María Eugenia, Antonio‐Villa, Neftali Eduardo, Núñez, Isaac, Gutiérrez‐Romero, Alonso, Hernández‐Vanegas, Laura, Mar Saniger‐Alba, María, Carrillo‐Mezo, Roger, Ceballos‐Liceaga, Santa Elizabeth, Carbajal‐Sandoval, Guillermo, Flores‐Silva, Fernando Daniel, Díaz‐Ortega, José Luis, Cortes‐Alcalá, Ricardo, Pérez‐Padilla, José Rogelio, López‐Gatell, Hugo, Chiquete, Erwin, Reyes‐Terán, Gustavo, Arauz, Antonio, Valdés‐Ferrer, Sergio Iván
• Format: Journal Article
• Language: English
• Published: Oxford John Wiley & Sons, Inc 01.11.2022; John Wiley and Sons Inc
• Subjects: adverse events; COVID-19; COVID-19 vaccines; Demyelination; Diarrhea; Epidemiology; Guillain-Barre syndrome; Guillain–Barré syndrome; Immunization; Intravenous administration; mRNA; Original; SARS‐CoV‐2; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Vaccines; Virions
• ISSN: 1351-5101; 1468-1331
• DOI: 10.1111/ene.15504

Background and purpose Information on Guillain–Barré syndrome (GBS) as an adverse event following immunization (AEFI) against SARS‐CoV‐2 remains scarce. We aimed to report GBS incidence as an AEFI among adult (≥18 years) recipients of 81,842,426 doses of seven anti‐SARS‐CoV‐2 vaccines between December 24, 2020, and October 29, 2021, in Mexico. Methods Cases were retrospectively collected through passive epidemiological surveillance. The overall observed incidence was calculated according to the total number of administered doses. Vaccines were analyzed individually and by vector as mRNA‐based (mRNA‐1273 and BNT162b2), adenovirus‐vectored (ChAdOx1 nCov‐19, rAd26‐rAd5, Ad5‐nCoV, and Ad26.COV2‐S), and inactivated whole‐virion‐vectored (CoronaVac) vaccines. Results We identified 97 patients (52 males [53.6%]; median [interquartile range] age 44 [33–60] years), for an overall observed incidence of 1.19/1,000,000 doses (95% confidence interval [CI] 0.97–1.45), with incidence higher among Ad26.COV2‐S (3.86/1,000,000 doses, 95% CI 1.50–9.93) and BNT162b2 recipients (1.92/1,00,000 doses, 95% CI 1.36–2.71). The interval (interquartile range) from vaccination to GBS symptom onset was 10 (3–17) days. Preceding diarrhea was reported in 21 patients (21.6%) and mild COVID‐19 in four more (4.1%). Only 18 patients were tested for Campylobacter jejuni (positive in 16 [88.9%]). Electrophysiological examinations were performed in 76 patients (78.4%; axonal in 46 [60.5%] and demyelinating in 25 [32.8%]); variants were similar across the platforms. On admission, 91.8% had a GBS disability score ≥3. Seventy‐five patients (77.3%) received intravenous immunoglobulin, received seven plasma exchange (7.2%), and 15 (15.5%) were treated conservatively. Ten patients (10.3%) died, and 79.1% of survivors were unable to walk independently. Conclusions Guillain–Barré syndrome was an extremely infrequent AEFI against SARS‐CoV‐2. The protection provided by these vaccines outweighs the risk of developing GBS.