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Adverse events of special interest following the use of BNT162b2 in adolescents: a population-based retrospective cohort study

Lai, Francisco Tsz Tsun; Chua, Gilbert T; Chan, Edward Wai Wa; Huang, Lei; Kwan, Mike Yat Wah; Ma, Tiantian; Qin, Xiwen; ... Ip, Patrick; + view all (2022) Adverse events of special interest following the use of BNT162b2 in adolescents: a population-based retrospective cohort study. Emerging Microbes & Infections , 11 (1) pp. 885-893. 10.1080/22221751.2022.2050952. Green open access

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Abstract

Accruing evidence suggests an increased risk of myocarditis in adolescents from messenger RNA COVID-19 vaccines. However, other potential adverse events remain under-researched. We conducted a retrospective cohort study of adolescents aged 12–18 with a territory-wide electronic healthcare database of the Hong Kong population linked with population-based vaccination records and supplemented with age- and sex-specific population numbers. Two age- and sex-matched retrospective cohorts were formed to observe 28 days following the first and second doses of BNT162b2 and estimate the age- and sex-adjusted incidence rate ratios between the vaccinated and unvaccinated. Thirty AESIs adapted from the World Health Organization’s Global Advisory Committee on Vaccine Safety were examined. Eventually, the first-dose cohort comprised 274,881 adolescents (50.25% received the first dose) and the second-dose cohort 237,964 (50.29% received the second dose). Ninety-four (34.2 per 100,000 persons) adolescents in the first-dose cohort and 130 (54.6 per 100,000 persons) in the second-dose cohort experienced ≥1 AESIs. There were no statistically significant differences in the risk of any AESI associated with BNT162b2 except myocarditis [first-dose cohort: incidence rate ratio (IRR) = 9.15, 95% confidence interval (CI) 1.14–73.16; second-dose cohort: IRR = 29.61, 95% CI 4.04–217.07] and sleeping disturbances/disorders after the second dose (IRR = 2.06, 95% CI 1.01–4.24). Sensitivity analysis showed that, with myocarditis excluded as AESIs, no significantly elevated risk of AESIs as a composite outcome associated with vaccination was observed (P = 0.195). To conclude, the overall absolute risk of AESIs was low with no evidence of an increased risk of AESIs except myocarditis and sleeping disturbances/disorders.

Type: Article
Title: Adverse events of special interest following the use of BNT162b2 in adolescents: a population-based retrospective cohort study
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1080/22221751.2022.2050952
Publisher version: https://doi.org/10.1080/22221751.2022.2050952
Language: English
Additional information: © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group, on behalf of Shanghai Shangyixun Cultural Communication Co., Ltd This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Chinese, SARS-CoV-2, coronavirus, immunization, reactogenicity, Adolescent, BNT162 Vaccine, COVID-19, COVID-19 Vaccines, Child, Cohort Studies, Female, Humans, Male, Retrospective Studies
UCL classification: UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Practice and Policy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
URI: https://discovery-pp.ucl.ac.uk/id/eprint/10145797
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