Suspected Cases of Adverse Reactions and Vaccination Complications after Vaccination with Comirnaty in Children aged 5 to 11 Years from Germany

Up to 3 March 2022, 859 suspected cases of an adverse reaction after Comirnaty in children aged 5 to 11 years were reported to the Paul-Ehrlich-Institut. The reporting rate is four cases per 10,000 vaccinations, girls and boys were affected about equally often. The vast majority of adverse reactions were not severe. The reported reactions are similar to those in pre-approval clinical trials. No new risk signal was identified. No case of confirmed myocarditis and/or pericarditis was reported by the cut-off date of the evaluation.

The article "Suspected cases of adverse reactions and vaccine complications after vaccination with Comirnaty® in children aged 5 to 11 years from Germany" provides a summary of the reports including the preliminary safety results of the spontaneous reporting system.