Abstract
Purpose
Retrospective evaluation of long-term safety of BNT162b2 in children < 18 years in Germany compared to non-SARS-CoV-2 vaccines.
Methods
This investigator initiated longitudinal cohort study retrospectively assessed the long-term safety of BNT162b2 using an online questionnaire addressed to parents of vaccinated children. Between May 25th and July 11th we contacted 15423 E-Mail-addresses registered in databases of vaccination centre. Inclusion criteria were at least one BNT162b2 vaccination after October 1st, 2021 < 18 years of age and using a valid authentication code. An active comparator analysis was performed to compare BNT162b2 to non-SARS-CoV-2 vaccines.
Results
3228 children (median age, 5.7 [IQR, 3.4–9.5]; male, 49.6%) who received ≥ 1 dose of BNT162b2 < 18 years were followed up for a median of 524 days (IQR, 500–553 days). Across all age groups, the active-comparator analysis revealed significantly increased rates of post-vaccination symptoms in 10 of 11 categories occurring after BNT162b2 compared to non-SARS-CoV-2 vaccines. In 41 cases symptom duration ≥ 90 days are reported and most frequently affected the neurological, psychological and dermatological system. Relative probability of reporting a serious adverse event was significantly increased if participants were female (OR, 4.55; 95% CI, 2.10–9.88) or took long-term medication (OR, 3.67; 95% CI, 1.39–9.69). No causality can be verified based on the available data.
Conclusion
BNT162b2 is well tolerated by 98% of children, but specific symptoms occur significantly more frequently than in non-SARS-CoV-2 vaccines. In rare cases (1.4%) symptoms persisted ≥ 90 days. Question of causality should further be scrutinized in future prospective studies.
Clinical Trial Registration: This study was registered at the German Clinical Trials Register (Register-ID: DRKS00031994).