Validation of DaCVap in England
Research type
Research Study
Full title
Validation of Hospital based COVID-19 outcomes in England
IRAS ID
301740
Contact name
Simon DeLusignan
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 3 months, 3 days
Research summary
The aim of this study is to investigate the association between receiving first and second doses of the Pfizer-BioNTech and Oxford-Astra-Zeneca COVID-19 vaccines, as well as other vaccines currently licensed in the UK including the Moderna & Janssen and COVID-19 vaccines, and hospital admissions, mortality and vaccine waning.
An effective vaccine against COVID-19 constitutes a major public health need and may be the only way to guarantee a safe and sustained exit strategy and avoid escalating mortality rates across the globe. There is an urgent need to establish a full understanding of the vaccine to underpin public trust.
A hospital admission is defined as one that takes place within 28 days of an RT-PCR positive test for COVID-19, or admission with ICD-10 code for COVID-19.
Rates of hospitalisation and death will be estimated in the vaccinated and unvaccinated groups; for example, a ratio less than one indicates smaller rates of hospitalisation in the vaccinated compared to the unvaccinated groups. Statistical adjustment of these rates will take into account other risk factors for hospitalisation and death. 1 minus the ratio of these rates serves as the final measure of vaccine effectiveness (as a percentage).
We will further test the hypothesis that vaccine effectiveness (VE) estimates against COVID-19 hospitalisation and death decrease over time.
REC name
London - Central Research Ethics Committee
REC reference
21/HRA/2786
Date of REC Opinion
1 Jul 2021
REC opinion
Favourable Opinion