Association of New-Onset Seizures with SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Ali Rafati, Melika Jameie, Mobina Amanollahi, Yeganeh Pasebani, Mana Jameie, Ali Kabiri, Sara Montazeri Namin, Delaram Sakhaei, Fateme Feizollahi, Mohammad Yazdan Pasebani, Hossein Mohebbi, Saba Ilkhani, Mohammadreza Azadi, Mehran Rahimlou, Churl Su Kwon

Research output: Contribution to journalArticlepeer-review

Abstract

Importance: Seizures have been reported as an adverse effect of the SARS-CoV-2 vaccine. However, no study has answered the question of whether there is any association between seizures in the general population and COVID-19 vaccination. Objective: To evaluate the seizure incidence among SARS-CoV-2 vaccine recipients compared with those who received a placebo. Data Sources: A systematic search of MEDLINE (via PubMed), Web of Science, Scopus, Cochrane Library, Google Scholar, review publications, editorials, letters to editors, and conference papers, along with the references of the included studies from December 2019 to July 7, 2023. Study Selection: Randomized clinical trials (RCTs) reporting seizure incidence with SARS-CoV-2 vaccination were included. Data Extraction and Synthesis: This study is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework and used the Mantel-Haenszel method with random- and common-effect models. The risk of bias of the studies was assessed using the Cochrane assessment tool for RCTs. Main Outcomes and Measures: The outcome of interest was new-onset seizure incidence proportion compared among (1) SARS-CoV-2 vaccine recipients and (2) placebo recipients. Results: Six RCTs were included in the study. Results of the pooled analysis comparing the incidence of new-onset seizure between the 63521 vaccine and 54919 placebo recipients in the 28-day follow-up after vaccine/placebo injection showed no statistically significant difference between the 2 groups (9 events [0.014%] in vaccine and 1 event [0.002%] in placebo recipients; odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P =.12; I2= 0%, τ2 = 0, Cochran Q P =.74). Likewise, in the entire blinded-phase period after injection, with a median of more than 43 days, no significant difference was identified between the vaccine and placebo groups regarding incident new-onset seizure (13/43724 events [0.03%] in vaccine and 5/40612 [0.012%] in placebo recipients; OR, 2.31; 95% CI, 0.86-6.23, P =.10, I2= 0%, τ2 = 0, Cochran Q P =.95). Conclusions and Relevance: According to this systematic review and meta-analysis, there was no statistically significant difference in the risk of new-onset seizure incidence between vaccinated individuals and placebo recipients..

Original languageEnglish
Pages (from-to)611-618
Number of pages8
JournalJAMA Neurology
Volume81
Issue number6
DOIs
StatePublished - 10 Jun 2024
Externally publishedYes

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