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Objective: This study aims to create a national ethnicity spine based on all available ethnicity records in linkable anonymised electronic health record and administrative data sources., Design: A longitudinal study using anonymised individual-level population-scale ethnicity data from 26 data sources available within the Secure Anonymised Information Linkage Databank., Setting: The national ethnicity spine is created based on longitudinal national data for the population of Wales-UK over 22 years (between 2000 and 2021)., Procedure and Participants: A total of 46 million ethnicity records for 4 297 694 individuals have been extracted, harmonised, deduplicated and made available within a longitudinal research ready data asset., Outcome Measures: (1) Comparing the distribution of ethnicity records over time for four different selection approaches (latest, mode, weighted mode and composite) across age bands, sex, deprivation quintiles, health board and residential location and (2) distribution and completeness of records against the ONS census 2011., Results: The distribution of the dominant group (white) is minimally affected based on the four different selection approaches. Across all other ethnic group categorisations, the mixed group was most susceptible to variation in distribution depending on the selection approach used and varied from a 0.6% prevalence across the latest and mode approach to a 1.1% prevalence for the weighted mode, compared with the 3.1% prevalence for the composite approach. Substantial alignment was observed with ONS 2011 census with the Latest group method (kappa=0.68, 95% CI (0.67 to 0.71)) across all subgroups. The record completeness rate was over 95% in 2021., Conclusion: In conclusion, our development of the population-scale ethnicity spine provides robust ethnicity measures for healthcare research in Wales and a template which can easily be deployed in other trusted research environments in the UK and beyond., Competing Interests: Competing interests: KK is Director of the University Centre for Ethnic Health Research, Trustee of the South Asian Health Foundation, Chair of the Ethnicity subgroup of the UK Scientific Advisory Group for Emergencies (SAGE) and member of SAGE. RL is a member of the Welsh Government COVID-19 Technical Advisory Group. RKO is a member of the National Institute for Health and Care Excellence (NICE) Technology Appraisal Committee, a member of the NICE Decision Support Unit (DSU) and an associate member of the NICE Technical Support Unit (TSU). She has provided unrelated methodological advice as a paid consultant to the pharmaceutical industry. She reports teaching fees from the Association of British Pharmaceutical Industry (ABPI) and the University of Bristol., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: The novel coronavirus SARS-CoV-2, which emerged in December 2019, has caused millions of deaths and severe illness worldwide. Numerous vaccines are currently under development of which a few have now been authorised for population-level administration by several countries. As of 20 September 2021, over 48 million people have received their first vaccine dose and over 44 million people have received their second vaccine dose across the UK. We aim to assess the uptake rates, effectiveness, and safety of all currently approved COVID-19 vaccines in the UK., Methods and Analysis: We will use prospective cohort study designs to assess vaccine uptake, effectiveness and safety against clinical outcomes and deaths. Test-negative case-control study design will be used to assess vaccine effectiveness (VE) against laboratory confirmed SARS-CoV-2 infection. Self-controlled case series and retrospective cohort study designs will be carried out to assess vaccine safety against mild-to-moderate and severe adverse events, respectively. Individual-level pseudonymised data from primary care, secondary care, laboratory test and death records will be linked and analysed in secure research environments in each UK nation. Univariate and multivariate logistic regression models will be carried out to estimate vaccine uptake levels in relation to various population characteristics. VE estimates against laboratory confirmed SARS-CoV-2 infection will be generated using a generalised additive logistic model. Time-dependent Cox models will be used to estimate the VE against clinical outcomes and deaths. The safety of the vaccines will be assessed using logistic regression models with an offset for the length of the risk period. Where possible, data will be meta-analysed across the UK nations., Ethics and Dissemination: We obtained approvals from the National Research Ethics Service Committee, Southeast Scotland 02 (12/SS/0201), the Secure Anonymised Information Linkage independent Information Governance Review Panel project number 0911. Concerning English data, University of Oxford is compliant with the General Data Protection Regulation and the National Health Service (NHS) Digital Data Security and Protection Policy. This is an approved study (Integrated Research Application ID 301740, Health Research Authority (HRA) Research Ethics Committee 21/HRA/2786). The Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub meets NHS Digital's Data Security and Protection Toolkit requirements. In Northern Ireland, the project was approved by the Honest Broker Governance Board, project number 0064. Findings will be made available to national policy-makers, presented at conferences and published in peer-reviewed journals., Competing Interests: Competing interests: AS is a member of the Scottish Government Chief Medical Officer’s COVID-19 Advisory Group. RAL reports grants from MRC during the conduct of the study. SJS reports grants from Wellcome Trust, during the conduct of the study; grants from National Institute of Healthcare Research HTA, grants from Tommy's Charity and grants from Chief Scientist for Scotland, outside the submitted work. SdeL is Director of the Royal College of General Practitioners Research and Surveillance Centre. He has received grant funding through his University from AstraZeneca, Eli Lilly, GSK MSD, Seqirus and Takeda. He has been members of advisory boards for AstraZeneca, Sanofi, and Seqirus. DB is jointly employed by Queen’s University Belfast, the Public Health Agency and the Department of Health (Northern Ireland), and he is currently or has been a member of COVID-19 government advisory groups, including the Scientific Advisory Group for Emergencies (SAGE), its subgroups, and the UK Vaccine Effectiveness Expert Panel. All other authors report no conflicts of interest., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)