AstraZeneca UK Limited

Commercial

No

DARS-NIC-445543-W0D4N-v1.2

The vaccine has been proven to be effective in trials thus far, 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 expected 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 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, Oxford-AstraZeneca 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 the 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 Oxford-AstraZeneca hope will 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 Oxford-AstraZeneca 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.

27/07/2021

De-Personalised

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

Not applicable

Recurring

TRE