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Febrile seizure risk following monovalent COVID-19 mRNA vaccination in US children aged 2-5 years
Steven A Anderson1, Elizabeth R Smith2, Zhiruo Wan2
1US Food and Drug Administration, Silver Spring, MD, USA.
Insights
The monovalent mRNA-1273 COVID-19 vaccine showed a small increased risk of febrile seizures in children aged 2-5 years within 2 days of vaccination. The BNT162b2 vaccine did not show a statistically significant increase in febrile seizure risk.
Area of Science:
- Pediatric infectious disease
- Vaccine safety research
- Epidemiology
Background:
- The safety of COVID-19 vaccination in pediatric populations is crucial for public health.
- Monovalent mRNA vaccines (mRNA-1273 and BNT162b2) were authorized for children aged 2-5 years.
- Febrile seizures are a known potential adverse event in young children.
Purpose of the Study:
- To assess the risk of febrile seizures following monovalent COVID-19 mRNA vaccination in children aged 2-5 years.
- To compare the incidence of febrile seizures in the immediate post-vaccination period with a later control period.
Main Methods:
- A self-controlled case series analysis was conducted using three commercial insurance databases.
- The study compared febrile seizure risk in the 0-1 day interval post-vaccination to a 8-63 day control interval.
- Conditional Poisson regression and meta-analyses were used to estimate incidence rate ratios (IRR) and confidence intervals (CI).
Main Results:
- The mRNA-1273 vaccine was associated with a statistically significant increased incidence of febrile seizures (IRR: 2.52) in the 0-1 day period.
- For the BNT162b2 vaccine, the IRR for febrile seizures was elevated but not statistically significant (IRR: 1.41).
- The risk difference for mRNA-1273 was 3.22 per 100,000 doses, with a non-significant CI.
Conclusions:
- A small, elevated incidence rate ratio of febrile seizures was observed within 0-1 days following mRNA-1273 vaccination in children aged 2-5 years.
- The study did not find a statistically significant increase in febrile seizures following BNT162b2 vaccination in this age group.
- Findings contribute to the ongoing monitoring of COVID-19 vaccine safety in pediatric populations.
Objective:
To evaluate febrile seizure risk following monovalent COVID-19 mRNA vaccination among children aged 2-5 years.
Methods:
The primary analysis evaluated children who had a febrile seizure outcome in the 0-1 days following COVID-19 vaccination. A self-controlled case series analysis was performed in three commercial insurance databases to compare the risk of seizure in the risk interval (0-1 days) to a control interval (8-63 days). The exposure of interest was receipt of dose 1 and/or dose 2 of monovalent COVID-19 mRNA vaccinations. The primary outcome was febrile seizure (0-1 day risk interval). A conditional Poisson regression model was used to compare outcome rates in risk and control intervals and estimate incidence rate ratios (IRR) and 95% confidence intervals (CIs). Meta-analyses were used to pool results across databases.
Results:
The primary meta-analysis found a statistically significant increased incidence of febrile seizure, in the 0-1 days following mRNA-1273 vaccination compared to the control interval (IRR: 2.52, 95% CI: 1.35 to 4.69, risk difference (RD)/100,000 doses = 3.22 (95% CI -0.31 to 6.75)). For the BNT162b2 vaccination, the IRR was elevated but not statistically significant (IRR: 1.41, 95% CI: 0.48 to 4.11, RD/100,000 doses = -0.25 (95% CI -2.75 to 2.24).
Conclusions:
Among children aged 2-5 years, the analysis showed a small elevated incidence rate ratio of febrile seizures in the 0-1 days following the mRNA-1273 vaccination.
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