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.

Emma Copland, Martina Patone, Defne Saatci, Lahiru Handunnetthi, Jennifer Hirst, David P. J. Hunt, Nicholas L. Mills, Paul Moss, Aziz Sheikh, Carol A. C. Coupland, Anthony Harnden, Chris Robertson, Julia Hippisley-Cox