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Observational Study
. 2026 Jan 1;37(1):141-151.
doi: 10.1097/EDE.0000000000001908. Epub 2025 Sep 23.

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 C A 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 C J Bacon  1 , Ben Goldacre  1 , Miguel A Hernan  5 , Jonathan A C Sterne  3 , William J Hulme  1 ; OpenSAFELY Collaborative
Affiliations
Observational Study

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 the 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 (1) the first vaccination to unvaccinated controls and (2) the 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, and COVID-19 death; with safety outcomes, A&E attendance, unplanned hospitalization, pericarditis, and myocarditis.

Results: Among 820,926 previously unvaccinated adolescents, 20-week incidence rate ratios (IRRs) 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. Among 441,858 adolescents who had received the 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 hospitalization. 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 the first and second doses, respectively.

Conclusions: BNT162b2 vaccination in adolescents reduced COVID-19 A&E attendance and hospitalization, 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

Disclosure: B.G. 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 Organization, UKRI MRC, Asthma UK, the British Lung Foundation, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme; is a Nonexecutive Director at NHS Digital; and also receives personal income from speaking and writing for lay audiences on the misuse of science. B.M.K. is also employed by NHS England, and working on medicines policy and clinical lead for primary care medicines data. The other authors have no conflicts to report.

Figures

FIGURE 1.
FIGURE 1.
Kaplan–Meier estimates of cumulative incidence of outcomes in adolescents.
FIGURE 2.
FIGURE 2.
Kaplan–Meier estimates of cumulative incidence of outcomes in children.
See this image and copyright information in PMC

References

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    1. NHS Rolls Out COVID Vaccine to Five Million 5 to 11 Year Olds. NHS England. Available at: https://www.england.nhs.uk/2022/04/nhs-rolls-out-COVID-vaccine-to-five-m.... Accessed 3 August 2025.
    1. NHS to Rollout Boosters to Most at Risk 12 to 15 Year-Olds. NHS England. Available at: https://www.england.nhs.uk/2022/01/nhs-to-rollout-boosters-to-most-at-ri.... Accessed 3 August 2025.
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    1. Walter EB, Talaat KR, Sabharwal C, et al. Evaluation of the BNT162b2 COVID-19 vaccine in children 5 to 11 years of age. N Engl J Med. 2022;386:3546. - PMC - PubMed

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