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%, t2 = 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%, t2 = 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.
| Discipline Area | Score |
|---|---|
| Public Health |  |
| Infectious Disease |  |
| Pediatrics (General) | |
| Neurology |  |
| Family Medicine (FM)/General Practice (GP) | |
| General Internal Medicine-Primary Care(US) | |
There was little hypothetical rationale suggesting these vaccines cause seizures. I have no idea why this was studied.
Controversy has swirled around Covid vaccines, mostly in the public-facing literature. This careful meta-analysis with all the caveats attendant in the methodology, fails to show an increase in seizures following vaccination. In the absence of a large prospective study, which is unlikely to be done, this is probably the best we will get. It should be reassuring to both physicians and community members.
Complication of SARS-CoV-2 vaccines might not generate much interest in 2024; however, as fears of vaccine complications continue, this study might be of some importance. The results assure the safety of vaccines, which confirmation is largely known.
This is an important meta-analysis. The conclusion is important as there was hardly any difference in almost 120,000 recipients, of whom about 45% received the placebo.
