More evidence for COVID-19 vaccine safety in kids

COVID-19 vaccines can be safely administered in children, with a recent study showing that out of the numerous health outcomes monitored in near real time, the safety signal identified was for only myocarditis or pericarditis.

For the study, researchers conducted near–real-time monitoring of 20 health outcomes following BNT162b2 COVID-19 vaccination in the US paediatric population aged 5–17 years. All health outcomes were monitored descriptively, 13 of which additionally required sequential testing. For these 13 health outcomes, the risk of each outcome following vaccination was evaluated against a historical baseline.

The primary analysis evaluated the safety of primary series doses together (dose 1 + dose 2), with dose-specific secondary analyses also conducted. A total of 3,017,352 young participants were included. Of these, 1,510,817 participants (50.1 percent) were boys, 1,506,499 (49.9 percent) were girls, and 2,867,436 (95.0 percent) lived in an urban area.

In the primary sequential analyses, myocarditis or pericarditis emerged as the sole safety signal observed after primary series vaccination with BNT162b2 in the 12-to-17-year age group. No safety signals for the 12 other outcomes assessed using sequential testing were seen.

The findings are consistent with other published reports and establish the safety of COVID-19 vaccines in children.