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

Abstract

To provide further evidence on the safety profile of COVID-19 vaccines in paediatrics by analysing the spontaneous reports of adverse effects related to these vaccines. Reports related to US paediatric population (from 0 to 17 years) vaccinated with authorised COVID-19 vaccines were extracted from Vaccine Adverse Event Reporting System from December 2020 to 17 November 2022. We conducted a descriptive analysis of Adverse Events Following Immunization (AEFI), calculating reporting rate of serious AEFIs and focusing on myocarditis and Guillain-Barré Syndrome after mRNA COVID-19 vaccines. Overall, 52 720 reports were retrieved: 77% (40541)-Pfizer-BioNTech, 19% (10083)-Moderna, a small proportion for other vaccines 4% (2096). Most of AEFIs were non-serious and listed in corresponding SPCs. Of serious AEFIs, 96% were related to the Pfizer-BioNTech vaccine. Roughly 91% (47874) were related to people from 6 to 17 years, a small percentage of 9% (4773) to the younger group (0-5 years). In both groups, most of the reports were related to mRNA vaccines and the percentage of AEFIs experienced by females were similar to males. Data showed that events most frequently reported were non-serious and listed in the corresponding SPCs, extending the evidence of safety of COVID-19 vaccines authorised in the United States in children.