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National Core Study - Data and Connectivity: COVID-19 Vaccines Pharmacovigilance (DaC-VaP)

Safe People

Organisation name

Queen's University Belfast

Organisation sector

Academic Institute

Applicant name(s)

Dr Declan Bradley

Funders/ Sponsors

Queen's University BelfastHealth Data Research UKwider NCS team

Safe Projects

Project ID

36367500000000000, E064

Lay summary

The aim of this study is to assess the safety, effectiveness and uptake of the currently licenced COVID-19 vaccines (Pfizer-BioNTech, Oxford-AstraZeneca and Moderna) in the UK. To do this, we will use anonymised individual level data routinely collected at primary, secondary, linked with mortality, laboratory and vaccination data across the UK. Unique national datasets will be developed and hosted within a Trusted Research Environment (TRE) in each UK nation with standardised individual-level analyses run across datasets. Pooled estimates across the UK national will also be provided. Specifically, our objectives are to: a) assess any vaccine related adverse events; b) assess vaccine effectiveness (VE) including household transmission; and c) measure variation in vaccine uptake

Public benefit statement

The findings from this study are anticipated to provide important public health information on uptake characteristics and the safety and effectiveness of the vaccination programme in the NI population.

Latest approval date

18/03/2021

Safe Data

Dataset(s) name

National Health Application and Infrastructure Services (NHAIS)

GRO Mortaltiy Data

VMS

PAS

Data sensitivity level

Anonymous

Legal basis for provision of data under Article 6

Not applicable

Common Law Duty of Confidentiality

Not applicable

National data opt-out applied?

Not applicable

Request frequency

Recurring

Safe Setting

Access type

TRE