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

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.