Uptake, effectiveness, and safety of COVID-19 vaccines [COVID-19]
Research type
Research Study
Full title
Uptake, effectiveness, and comparative safety of new COVID-19 vaccines by age, sex, region, ethnicity, comorbidities, medication, deprivation, risk level and evidence of prior COVID infection.
IRAS ID
300573
Contact name
Julia Hippisley-Cox
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
The aim is to undertake rapid assessment of uptake, safety and effectiveness of the new COVID-19 vaccines by examining effectiveness and risks of a range of serious outcomes among people receiving the different vaccines and unvaccinated patients. We will achieve this through the analysis of GP electronic health records linked to hospital, mortality and vaccination records. The study is funded as a national priority study via HDR-UK and NIHR.
The secondary objectives are:(A) To determine vaccine uptake by vaccine type and subgroups including age, sex, ethnicity, deprivation, region, co-morbidities (including transplants), medication use and QCovid risk score and prior COVID-19 status. This will include analyses of patients where two different vaccinations may have been used in an individual.
(B) To determine vaccine safety by vaccine type and time since vaccination and by subgroups including age, sex, ethnicity, deprivation, region, care home status, household size, co-morbidities8 (including transplants), medication and prior COVID-19 status (including new variants of concern).
(C) To estimate vaccine effectiveness by evaluating the risk and severity of a COVID-19 diagnosis by vaccine type, time since vaccination and following one or two doses of vaccination and by previous COVID-19 positivity status and co-morbidity.Summary of Results
The study was not actually activated under this approval. The reason was that the relevant data became available from an existing REC approved database (18/EM/0400) which is the QResearch data linkage project. The study is being reported via the annual reports for 18/EM/0400 (IRAS 257790) https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbZPWkiaLoTn5nyfqPM65-2BR2XH50vW8lfnsEqFvU9-2Bxxtn2MnOW1qqIeeq5PSwA0Wb6SRx6u4aDK6zOjAN6e2MPbNfZDNYq-2Fo04qIX79snv-2BjRBNz_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLbulB2s161qd5ZH0yHL6yegkNdoeX1-2BGOwvNafLZHsjn-2FjYCWvI6ugUgI5sLdQLQFnbS1xyR0nY3KoudXkoIEy39eV2XETDk4d9SXHqA8rMIqFWZD0i15bdP9-2BeP1IQEpWR-2BjAO6FKNRrqtLWfto-2BL2kWHs6aApF8rjZlLol0k-2BQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C5322c43542654868092808db4c8ea5c1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638187947789181074%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=e07R1ySorPuJKPiNKtn8xiDJsOYyMovdebqob206Ong%3D&reserved=0 project OX107
REC name
London - London Bridge Research Ethics Committee
REC reference
21/HRA/2058
Date of REC Opinion
26 May 2021
REC opinion
Favourable Opinion