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Article History

Received: 12 August 2024

Accepted: 15 November 2024

First Online: 12 April 2025

Competing interests

: I.J.D. has shares in GSK and grants from GSK and AstraZeneca. A.Y.S.W. received honorarium from 6th Annual meeting of the Society for Clinical Epidemiology in Tokyo and 28th Annual Meeting of the Japanese Society for Pharmacoepidemiology in Kyoto in November 2023, outside the submitted work. E.W.C. reports grants from Research Grants Council (RGC, Hong Kong), Research Fund Secretariat of the Food and Health Bureau, National Natural Science Fund of China, Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, and Narcotics Division of the Security Bureau of the Hong Kong Special Administrative Region; honorarium from Hospital Authority; outside the submitted work. C.S.L.C. has received grants from the Food and Health Bureau of the Hong Kong Government, Hong Kong Research Grant Council, Hong Kong Innovation and Technology Commission, Pfizer, IQVIA, MSD, and Amgen; and personal fees from PrimeVigilance; outside the submitted work. I.C.K.W. reports research funding from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, the Hong Kong Research Grants Council of the Government of the Hong Kong SAR, the Hong Kong Health and Medical Research Fund, the National Institute for Health Research in England, the European Commission, and the National Health and Medical Research Council in Australia, consulting fees from IQVIA and World Health Organisation, payment for expert testimony for Appeal Court of Hong Kong and is a non-executive director of Jacobson Medical in Hong Kong, Advance Data Analytics for Medical Science (ADAMS) Limited (HK), Asia Medicine Regulatory Affairs (AMERA) Services Limited and OCUS Innovation Limited (HK, Ireland and UK) a former director of Therakind in England, outside of the submitted work. ICKW reports its role as a member of the Pharmacy and Poisons Board in Hong Kong, the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation, and the Advisory Panel on COVID-19 Vaccines of the Hong Kong Government.

: The analyses in the case study used only de-identified patient-level data, and therefore, individual informed consent was not required. The Hong Kong study was approved by the institutional review board of the University of Hong Kong/Hospital Authority Hong Kong West cluster (UW 20-017). The UK study protocol was approved by the London School of Hygiene and Tropical Medicine ethics committee (29592) and the Independent Scientific Advisory Committee for the Medicines and Healthcare Products Regulatory Agency (No. 23_002786).