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

Autor:	Rafati A; School of Medicine, Iran University of Medical Sciences, Tehran, Iran., Jameie M; Neuroscience Research Center, Iran University of Medical Sciences, Tehran, Iran.; Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran., Amanollahi M; Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran., Pasebani Y; School of Medicine, Iran University of Medical Sciences, Tehran, Iran., Jameie M; Cardiovascular Diseases Research Institute, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran., Kabiri A; School of Medicine, Iran University of Medical Sciences, Tehran, Iran., Montazeri Namin S; Cardiovascular Diseases Research Institute, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.; Cardiac Primary Prevention Research Center, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran., Sakhaei D; School of Medicine, Sari Branch, Islamic Azad University, Sari, Iran., Feizollahi F; School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Pasebani MY; Islamic Azad University East Tehran Branch, Tehran, Iran., Mohebbi H; Kermanshah University of Medical Sciences, Kermanshah, Iran., Ilkhani S; Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts., Azadi M; School of Medicine, Iran University of Medical Sciences, Tehran, Iran., Rahimlou M; Department of Nutrition, School of Public Health, Zanjan University of Medical Sciences, Zanjan, Iran., Kwon CS; Departments of Neurology, Epidemiology, Neurosurgery and the Gertrude H. Sergievsky Center, Columbia University, New York, New York.
Jazyk:	angličtina
Zdroj:	JAMA neurology [JAMA Neurol] 2024 Jun 01; Vol. 81 (6), pp. 611-618.
DOI:	10.1001/jamaneurol.2024.0967
Abstrakt:	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 63 521 vaccine and 54 919 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 (13/43 724 events [0.03%] in vaccine and 5/40 612 [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.
Databáze:	MEDLINE
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