Accepted for Publication: December 29, 2021.
Published Online: February 25, 2022. doi:10.1001/jamapediatrics.2022.0101
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Li X et al. JAMA Pediatrics.
Corresponding Authors: Ian Chi Kei Wong, PhD, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, University of Hong Kong; L2-57, Laboratory Block, 21 Sassoon Rd, Pok Fu Lam, The University of Hong Kong (wongick@hku.hk); Patrick Ip, MPH, Department of Paediatrics and Adolescent Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong; Room 115, New Clinical Building, Queen Mary Hospital, 102 Pok Fu Lam Rd, Hong Kong (patricip@hku.hk).
Author Contributions: Dr Wong had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Li, Lai, and Chua contributed equally as co–first authors.
Concept and design: Li, Kwan, Lau, Ip, Wong.
Acquisition, analysis, or interpretation of data: Li, Lai, Chua, Kwan, Ip, Wong.
Drafting of the manuscript: Li, Lai, Chua, Kwan.
Critical revision of the manuscript for important intellectual content: Lai, Chua, Kwan, Lau, Ip, Wong.
Statistical analysis: Li, Lai, Kwan.
Obtained funding: Wong.
Administrative, technical, or material support: Li, Chua, Kwan, Ip.
Supervision: Kwan, Lau, Ip, Wong.
Conflict of Interest Disclosures: Dr Li reported receiving grants from Research Grant Council/Early Career Scheme, Health and Medical Research Fund, Pfizer, Janssen, University of Hong Kong, and personal fees from Merck Sharp & Dohme outside the submitted work. Dr Wong reported receiving grants from Food and Health Bureau, The Government of the Hong Kong Special Administrative Region COVID19F01 during the conduct of the study; and research funding outside the submitted work from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, Takeda, the Hong Kong Research Grants Council, the Hong Kong Health and Medical Research Fund, National Institute for Health Research in England, European Commission, National Health and Medical Research Council in Australia, and receiving speaker fees from Janssen and Medice in the previous 3 years. The posts of Drs Wong and Lai were partly funded by The Laboratory of Data Discovery for Health (D24H); hence this work was partly supported by AIR@InnoHK administered by Innovation and Technology Commission. No other disclosures were reported.
Funding/Support: This study was regulatory-initiated pharmacovigilance and was funded by a research grant from the Food and Health Bureau of The Government of the Hong Kong Special Administrative Region (COVID19F01).
Role of the Funder/Sponsor: The funding organization provided record-linkage data via the Department of Health and Hospital Authority but has no role in the design and conduct of the study. The funding organization had no role in the management, analysis, and interpretation of the data. The funding organization reviewed and approved the manuscript but had no role in the preparing of the manuscript nor the decision to submit the manuscript for publication.
Additional Contributions: We appreciate the contributions of other investigators to the development of the COVID-19 Vaccines Adverse Events Response and Evaluation (CARE) Programme and the finalization of this study. We thank colleagues from the Drug Office of the Department of Health and the Hospital Authority for the generous provision of vaccination and clinical data. We thank Mr Kuan Peng (MHA, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, University of Hong Kong) and Ms Lei Huang (MSc, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, University of Hong Kong) for their assistance in data collection and analysis. We also thank Ms Lisa Lam (MJ, BSc, BA, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, University of Hong Kong) for proofreading the manuscript.
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