Risk of thrombotic thrombocytopenia and exposure to COVID-19 vaccines [COVID-19]
Research type
Research Study
Full title
An assessment of a relationship between the exposure to COVID-19 vaccines and risk of thrombotic thrombocytopenia syndrome
IRAS ID
300934
Contact name
Simon de Lusignan
Contact email
Sponsor organisation
AstraZeneca
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
The AstraZeneca (AZ) COVID-19 vaccine has been widely deployed across the United Kingdom (UK) and, along with the Pfizer and Moderna vaccines, represents an opportunity to prevent hospital admission and further deaths from COVID-19 as well as a route out of the restrictions imposed as a result of the pandemic. In recent times, a number of reports have suggested that the AZ vaccine may be linked to a rare syndrome known as thrombotic thrombocytopenia syndrome (TTS). The syndrome consists of blood clots forming in unusual places coinciding with a reduced level of platelets in the bloodstream. Given that TTS has been reported in those receiving the AZ vaccine of all ages, with a possible increased rate in younger people, as well as the potential poor outcomes associated with TTS, it is of urgent public health importance to study this proposed association. The UK is in a unique position to perform such a study given the registration-based primary care system and the use of a unique identifier number that links primary care with secondary care data.
This study, sponsored by AstraZeneca and carried out by the University of Oxford, will use multiple study designs in order to robustly explore the association between COVID-19 vaccine exposure and TTS. Using the linkage of a number of primary and secondary care databases through NHS Digital’s Data Access Request Service, the vast majority of the English population will be captured within this study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0157
Date of REC Opinion
14 Jun 2021
REC opinion
Favourable Opinion