Effectiveness of COVID-19 vaccines [COVID-19]
Research type
Research Study
Full title
The effectiveness of COVID-19 vaccines against clinical outcomes: a test negative case control study using OpenSAFELY
IRAS ID
296945
Contact name
Louise Lansbury
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
As soon as SARS-CoV2 was identified as the virus causing the ongoing COVID-19 pandemic, scientists and vaccine manufacturers worked rapidly to develop vaccines against it. Since late 2020, the UK has been rolling out a phased mass vaccination programme in the adult population, starting with people at greatest risk of severe infection. In clinical trials with volunteers, all three of the UK’s currently authorised vaccines were good at protecting recipients against infection but now that the vaccination programme is underway, it is important to look at how protective the vaccines are in the real world.
In this study we will evaluate how good each vaccine is at protecting people against infection with SARS-CoV2, and also at preventing serious outcomes of COVID-19 such as hospitalisation. We will compare COVID-19 vaccination status in people who have a positive SARS-CoV2 test with people who have a negative test (test-negative case control design). We will look at the vaccines’ effectiveness in particular subgroups, such as the elderly and people with poorly-functioning immune systems, to see if the vaccines work less well in some groups. We plan to run analyses at different time points after each vaccine dose and for up to 3 years to monitor if their effectiveness declines with time. We will use a secure analytic platform, OpenSAFELY, to run analysis codes against approximately 24 million routinely collected electronic health records (EHRs) for adult patients who are registered at GP practices. Patients are not identifiable from the data, which are analysed within the secure environment of the EHR software provider. This study will complement other studies using different data sources or study design, and will add to the body of knowledge to inform the government’s expert independent advisory body, the JCVI, when it make recommendations on future vaccination policy.
REC name
London - Brent Research Ethics Committee
REC reference
21/HRA/1614
Date of REC Opinion
27 Apr 2021
REC opinion
Favourable Opinion