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

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

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.

• Journal Article Type: Article
• Acceptance Date: Apr 11, 2024
• Online Publication Date: May 27, 2024
• Publication Date: May 27, 2024
• Deposit Date: Jun 4, 2024
• Publicly Available Date: Jun 4, 2024
• Journal: Nature Communications
• Electronic ISSN: 2041-1723
• Publisher: Nature Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 15
• Issue: 1
• Article Number: 3822
• DOI: https://doi.org/10.1038/s41467-024-47745-z
• Keywords: Epidemiology; Public health; SARS-CoV-2; Vaccines
• Public URL: https://nottingham-repository.worktribe.com/output/35712803
• Publisher URL: https://www.nature.com/articles/s41467-024-47745-z
• Additional Information: Received: 17 June 2023; Accepted: 11 April 2024; First Online: 27 May 2024; : J.H.C. reports grants from National Institute for Health Research (NIHR) Biomedical Research Centre, Oxford, John Fell Oxford University Press Research Fund, Cancer Research UK and Oxford Wellcome Institutional Strategic Support Fund and other research councils, during the conduct of the study outside the scope of this work. J.H.C. is founder and was shareholder until 9 Aug 2023 of ClinRisk Ltd, which produces open and closed source software to implement clinical risk algorithms (outside this work) into clinical computer systems. J.H.C. is an unpaid director of QResearch, a not-for-profit organisation which is a partnership between the University of Oxford and EMIS Health who supply the QResearch database used for this work and is a consultant for Endeavour Predict Ltd outside this work. A.S. serves on a number of UK and Scottish Government COVID-19 advisory groups and was a member of AstraZeneca’s Thrombotic Thrombocytopenic Taskforce; all roles are unremunerated. A.H. is Deputy Chair of the Joint Committee on Vaccination and Immunisation. D.H. serves on the UK Government Commission on Human Medicines P.M. has received speaker and advisory board fees from Moderna and Astra Zeneca. All other authors declare no competing interests related to this paper.