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Safety profile of paediatric COVID-19 vaccines: An analysis of the US Vaccine Adverse Event Reporting System

Victoria Nikitina1, Greta Santi Laurini1, Nicola Montanaro2

  • 1Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.

Acta Paediatrica (Oslo, Norway : 1992)
|August 23, 2023
PubMed

Insights

COVID-19 vaccine safety in children is supported by data showing most adverse events following immunization were non-serious. This analysis of US pediatric reports confirms the safety profile of authorized COVID-19 vaccines in this age group.

Area of Science:

  • Pediatric Vaccinology
  • Public Health Surveillance
  • Immunology

Background:

  • The safety of COVID-19 vaccines in pediatric populations requires ongoing evaluation.
  • Spontaneous reporting systems are crucial for monitoring vaccine safety post-authorization.

Purpose of the Study:

  • To assess the safety profile of COVID-19 vaccines in US children aged 0-17 years.
  • To analyze adverse events following immunization (AEFI) and specific serious events like myocarditis and Guillain-Barré Syndrome.

Main Methods:

  • Descriptive analysis of AEFI reports from the Vaccine Adverse Event Reporting System (VAERS) from December 2020 to November 2022.
  • Focus on pediatric population (0-17 years) receiving authorized COVID-19 vaccines.
  • Calculation of reporting rates for serious AEFIs, particularly after mRNA vaccines.

Main Results:

  • Over 52,000 reports were analyzed, with the majority concerning Pfizer-BioNTech and Moderna mRNA vaccines.
  • Most reported AEFIs were non-serious and consistent with product labeling.
  • Serious AEFIs constituted a small fraction, with 96% linked to Pfizer-BioNTech; 91% of all reports involved children aged 6-17 years.

Conclusions:

  • The study reinforces the safety of authorized COVID-19 vaccines in children.
  • Reported adverse events were predominantly non-serious and listed in the respective product's Summary of Product Characteristics (SPCs).
  • This analysis contributes to the evidence base for pediatric COVID-19 vaccination safety.
Abstract

Keywords:
COVID-19COVID-19 vaccineschildrenpaediatricpharmacovigilance

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