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. 2025 Sep 23.
doi: 10.1097/EDE.0000000000001908. Online ahead of print.

OpenSAFELY: Effectiveness of COVID-19 vaccination in children and adolescents

Colm D Andrews  1 , Edward P K Parker  2 , Elsie Horne  3 , Venexia Walker  3 , Tom Palmer  3 , Andrea L Schaffer  1 , Amelia Ca Green  1 , Helen J Curtis  1 , Alex J Walker  1 , Lucy Bridges  1 , Christopher Wood  1 , Victoria Speed  1 , Christopher Bates  4 , Jonathan Cockburn  4 , John Parry  4 , Amir Mehrkar  1 , Brian MacKenna  1 , Sebastian Cj Bacon  1 , Ben Goldacre  1 , Miguel A Hernan  5 , Jonathan Ac Sterne  3 , William J Hulme  1 ; OpenSAFELY Collaborative
Affiliations

OpenSAFELY: Effectiveness of COVID-19 vaccination in children and adolescents

Colm D Andrews et al. Epidemiology. .

Abstract

Background: We assessed the safety and effectiveness of first and second dose BNT162b2 COVID-19 vaccination, offered as part of the national COVID-19 vaccine roll-out from September 2021, in children and adolescents in England.

Methods: Our observational study using OpenSAFELY-TPP, included adolescents aged 12-15 years, and children aged 5-11 years. It compared individuals receiving i) first vaccination to unvaccinated controls and ii) second vaccination to single-vaccinated controls. We matched vaccinated individuals with controls on age, sex, and other important characteristics. Outcomes were positive SARS-CoV-2 test (adolescents only); COVID-19 accident and emergency (A&E) attendance; COVID-19 hospitalization; COVID-19 critical care admission; COVID-19 death, with safety outcomes A&E attendance, unplanned hospitalization, pericarditis, and myocarditis.

Results: Amongst 820,926 previously unvaccinated adolescents, 20-week incidence rate ratios (IRR) comparing vaccination with no vaccination were 0.74 for positive SARS-CoV-2 test, 0.60 for COVID-19 A&E attendance and 0.58 for COVID-19 hospitalization. Amongst 441,858 adolescents who had received first vaccination IRRs comparing second dose with single-vaccination were 0.67 for positive SARS-CoV-2 test, 1.00 for COVID-19 A&E attendance and 0.60 for COVID-19 hospitalisation. In both children groups COVID-19-related outcomes were too rare to allow IRRs to be estimated precisely. Across all analyses there were no COVID-19-related deaths, and fewer than seven COVID-19-related critical care admissions. Myocarditis and pericarditis were documented only in the vaccinated groups, with rates of 27 and 10 cases/million after first and second doses respectively.

Conclusions: BNT162b2 vaccination in adolescents reduced COVID-19 A&E attendance and hospitalisation, although these outcomes were rare. Protection against positive SARS-CoV-2 tests was transient.

Keywords: COVID; Coronavirus; Epidemiology; Pandemics; Pediatrics; Vaccines.

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Conflict of interest statement

Conflicts of Interest: BG has received research funding from the Laura and John Arnold Foundation, the NHS National Institute for Health Research (NIHR), the NIHR School of Primary Care Research, NHS England, the NIHR Oxford Biomedical Research Centre, the Mohn-Westlake Foundation, NIHR Applied Research Collaboration Oxford and Thames Valley, the Wellcome Trust, the Good Thinking Foundation, Health Data Research UK, the Health Foundation, the World Health Organisation, UKRI MRC, Asthma UK, the British Lung Foundation, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme; he is a Non-Executive Director at NHS Digital; he also receives personal income from speaking and writing for lay audiences on the misuse of science. BMK is also employed by NHS England working on medicines policy and clinical lead for primary care medicines data.

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