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Published online April 29, 2024.
doi:10.1001/jamaneurol.2024.0967
Ali Rafati, MD, MPH1; Melika Jameie, MD2,3; Mobina Amanollahi, MD3; et al
Key Points
Question Is incidence of new-onset seizures after SARS-CoV-2 vaccines statistically different from the incidence among individuals not receiving SARS-CoV-2 vaccines?
Findings This systematic review and meta-analysis showed that the incidence proportion of new-onset seizures after SARS-CoV-2 vaccination was not statistically different between vaccine recipients and placebo recipients or unvaccinated participants in the pooled analyses of more than 118 000 participants in randomized clinical trials.
Meaning The incidence of new-onset seizure was not significantly different between SARS-CoV-2 vaccine recipients and placebo recipients, and there was no evidence of increased new-onset seizure following SARS-CoV-2 vaccination in the general population.
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 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, 0.86-3.23, P > .99, 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.
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doi:10.1001/jamaneurol.2024.0967
Ali Rafati, MD, MPH1; Melika Jameie, MD2,3; Mobina Amanollahi, MD3; et al
Key Points
Question Is incidence of new-onset seizures after SARS-CoV-2 vaccines statistically different from the incidence among individuals not receiving SARS-CoV-2 vaccines?
Findings This systematic review and meta-analysis showed that the incidence proportion of new-onset seizures after SARS-CoV-2 vaccination was not statistically different between vaccine recipients and placebo recipients or unvaccinated participants in the pooled analyses of more than 118 000 participants in randomized clinical trials.
Meaning The incidence of new-onset seizure was not significantly different between SARS-CoV-2 vaccine recipients and placebo recipients, and there was no evidence of increased new-onset seizure following SARS-CoV-2 vaccination in the general population.
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 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, 0.86-3.23, P > .99, 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.
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