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

Copland, Emma and Patone, Martina and Saatci, Defne and Handunnetthi, Lahiru and Hirst, Jennifer and Hunt, David P. J. and Mills, Nicholas L. and Moss, Paul and Sheikh, Aziz and Coupland, Carol A. C. and Harnden, Anthony and Robertson, Chris and Hippisley-Cox, Julia (2024) Safety outcomes following COVID-19 vaccination and infection in 5.1 million children in England. Nature Communications, 15 (1). 3822. ISSN 2041-1723 (https://doi.org/10.1038/s41467-024-47745-z)

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Abstract

The risk-benefit profile of COVID-19 vaccination in children remains uncertain. A self-controlled case-series study was conducted using linked data of 5.1 million children in England to compare risks of hospitalisation from vaccine safety outcomes after COVID-19 vaccination and infection. In 5-11-year-olds, we found no increased risks of adverse events 1–42 days following vaccination with BNT162b2, mRNA-1273 or ChAdOX1. In 12-17-year-olds, we estimated 3 (95%CI 0–5) and 5 (95%CI 3–6) additional cases of myocarditis per million following a first and second dose with BNT162b2, respectively. An additional 12 (95%CI 0–23) hospitalisations with epilepsy and 4 (95%CI 0–6) with demyelinating disease (in females only, mainly optic neuritis) were estimated per million following a second dose with BNT162b2. SARS-CoV-2 infection was associated with increased risks of hospitalisation from seven outcomes including multisystem inflammatory syndrome and myocarditis, but these risks were largely absent in those vaccinated prior to infection. We report a favourable safety profile of COVID-19 vaccination in under-18s.