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.

Vaccine
|February 5, 2026
PubMed

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.
Abstract

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