Can we enable harmonised, near real-time, data on pharmacovigilance of COVID-19 vaccines using routinely collected linked national datasets across the UK?
The successfully awarded research project through a rapid funding call by Health Data Research UK, Office for National Statistics and UK Research and Innovation (UKRI) is led by Professor Aziz Sheikh (University of Edinburgh) and Lay Leads Jillian Beggs and Antony Chuter. The research project is building on existing UKRI and National Institute for Health Research (NIHR) work to use national data to answer this key COVID-19 vaccine research question.
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This research will look at how safe the COVID-19 vaccines are and how well they work in the general population. It will also look at how many people have the vaccine when they are offered it.
Pharmacovigilance is a word used to describe the science and activities relating to the detection, assessment, understanding and prevention of any side effects of a vaccine or drug.
The vaccines have been developed very quickly for COVID-19. Two of these vaccines (Pfizer BioNtech and Oxford-AstraZeneca) are now being used in the UK to protect people from the virus. Another vaccine (Moderna) will be used later in the year.
Initial tests in small groups of people have shown that these vaccines are safe and effective. However, we need to regularly check the safety of the vaccine as some side effects may only be found when more people have been vaccinated or may only develop after a period of time. The scientists will look for patterns in these very large amounts of data (millions of peoples records) to see how effective the vaccines are in stopping people getting COVID-19, or reducing the severity of COVID-19. For example, does the vaccine stop people with COVID-19 needing to be admitted to hospital. This research will also help determine the number of side effects and any safety concerns with the vaccines, and how long the protection may last.
The research will use the latest GP, hospital information and Covid testing data from electronic medical records data in the UK and all records will be processed to remove all the details that could identify people. The health records without personal details (de-identified data) will be stored safely and access will be restricted to a small number of approved scientists in secure settings.
The scientists will develop computer programs that will first be run in each of the four nations (England, Wales, Scotland and Northern Ireland) and then later be combined to give a UK-wide understanding of the vaccination programme. The computer programs will work to link the medical information data from GP records, along with data from hospitals about their COVID-19 patients.