AstraZeneca UK Limited

Commercial

No

DARS-NIC-459114-J3C1F-v0.5

The objective for processing the requested data is to support delivery of a real-world effectiveness study for COVID-19 vaccines in England. The primary objective of this study is the assess the real world effectiveness of the Oxford/AstraZeneca COVID-19 vaccine among people who receive one dose of the vaccine, overall and by age group and time period after 1 dose. The secondary objective of the study would be to: a) assess the vaccine effectiveness in people who have received the two doses; the timing after the 1st and 2nd dose , interval between the two doses and comorbidity status b) replicate the above analyses in people receiving the Pfizer COVID-19 vaccine as opposed to the Oxford/AstraZeneca vaccine. The requested datasets will be used to develop analysis code and algorithms for analyses in a smaller cohort to which they will be linked, prior to these analysis code (epidemiological models) and algorithms (ontological algorithms for case identification) being deployed in the national level data within the NHS Digital Trusted Research Environment (TRE) under data sharing agreement DARS-NIC-445543-W0D4N. The requested datasets will feed as an extract into the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub’s (ORCHID) Trusted Research Environment (TRE). The University of Oxford team run the national primary care surveillance system – The Oxford-Royal College of General Practitioners Research and Surveillance Centre (RSC). This surveillance system is sponsored by Public Health England (PHE) and collaborates in reporting vaccine uptake and effectiveness, including of COVID-19 vaccine. It obtains a refresh of data either daily or twice weekly and maintains a good level of data quality as a result. The team are also able to validate the analysis against the PHE data and other projects that include adverse events of interests associated to COVID-19 vaccines. Validation of the analyses would be beneficial to the team prior to commencing analyses within the NHS Digital TRE. Furthermore, the data within ORCHID is granular and the team have the ability to curate more variables in order to answer the research questions especially for adverse events of interests. Pseudonymised patient data is extracted from over 19,000 GP practices on a weekly basis to create the ORCHID database which is used for surveillance activities. The same pseudonymisation algorithm will be applied to all data involved in this study so the researchers can draw scientific conclusions for a study population. The requested datasets are as follows: Hospital Episode Statistics Admitted Patient Care Hospital Episode Statistics Critical Care Civil Registration - Deaths COVID-19 Second Generation Surveillance System COVID-19 UK Non-hospital Antibody Testing Results (Pillar 3) COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2) COVID-19 Vaccination Status Hospital Episode Statistics Admitted Patient Care

The vaccine has been proven to be effective in trials, this study is now necessary to conclude on a scientific basis how and to what extent this is effective in real world terms. Demonstrating effectiveness of the UK vaccination programme is in the public interest and successful implementation of the government roll-out strategy is critical to gaining control of the COVID-19 pandemic. The anticipated benefit expected from processing the data is to demonstrate the effectiveness of the COVID-19 vaccines and the UK vaccine roll-out in the adult population in England. Understanding of this effectiveness is greatly hoped to benefit citizens, healthcare professionals (HCPs), government and policy makers, vaccine manufacturers and researchers. AstraZeneca and University of Oxford specifically would get confirmation of the effectiveness of the Oxford-AstraZeneca vaccine which they hope will grow confidence in the product and support strategic decision-making in the future. Citizens and HCPs are hoped to benefit from evidence that will grow confidence in the vaccines, supporting vaccine uptake, and identifying sub groups of patients in whom the vaccines show greatest effect. Government and Policy makers are hoped to gain benefit from the evidence which will demonstrate the effectiveness of the vaccine roll-out plan with regards to staggered age groups and vulnerable groups. In just over 12 months, AstraZeneca/University of Oxford have developed a vaccine that is highly effective against all severities of COVID-19, and more than 500 million doses of the vaccine have been released for supply to 165 countries and it has helped save tens of thousands of lives since the start of the year. Whilst development has moved at pace the scientific rigor and safety standards have remained. Safety of AstraZeneca medicines is paramount both during clinical development and once approved for use. Real world data are critical to understanding the benefit-risk of COVID-19 vaccines and their effectiveness in clinical practice. With the rapid and massive deployment of COVID-19 vaccines, routine spontaneous safety event reporting systems have captured precedented and unprecedented adverse events of special interest, which require further corroboration of association and causality assessment. Simultaneously, effectiveness needs to be established with the real-world administration regimes, especially for those vaccines with two doses for a range of outcomes and use across different demographics. This study hopes to inform global use of the effectiveness of a first and second dose of COVID-19 Vaccine AstraZeneca and evaluate safety signals alongside other COVID-19 vaccines. The benefits are hoped to be identified for the various stakeholders are important. Evidence that helps to grow public confidence in vaccine effectiveness is highly important to minimize vaccine hesitancy and increase uptake of vaccine to help bring an end to the pandemic. With the UK being one of the first countries globally to have widespread vaccination, the study team are in a fairly unique position to be able to generate this evidence on a national level. This is on top of the health and emotional benefits to citizens gained through avoidance of severe COVID disease.

22/07/2021

Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Not applicable

One-Off

TRE