Safety outcomes following COVID-19 vaccination and infection in 5.1 million children in England

The risk–benefit profile of COVID-19 vaccination in children remains uncertain. We conducted a self-controlled case-series study using linked datasets for 5.1 million children in England to compare risks of hospitalisation for pre-specified safety outcomes following COVID-19 vaccination and SARS-CoV-2 infection. In 5–11-year-olds, we found no increased risks of adverse events in the 1–42 days after BNT162b2, mRNA-1273 or ChAdOx1 vaccination. In 12–17-year-olds, we estimated small increases in hospitalisations for myocarditis and epilepsy following BNT162b2, with excess events per million doses of approximately 3 (95% CI 0–5) and 5 (95% CI 3–6) for myocarditis after first and second doses, respectively, and a modest increase in epilepsy after the second dose. SARS-CoV-2 infection was associated with increased risks of hospitalisation for several outcomes including multisystem inflammatory syndrome in children (MIS-C) and myocarditis, whereas these risks were largely absent among vaccinated children. Overall, COVID-19 vaccination showed a favourable safety profile in under-18s.