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DRUG SAFETY RESEARCH UNIT
The DSRU is enrolling at least 15,000 patients who are then contacted at regular intervals after receiving the AstraZeneca vaccine, and asked whether they are experiencing any possible side effects. The study is one element of a series of measures to help protect the public, ensuring any adverse effects are quickly recognised and acted upon.
It is expected that this proactive approach, sourcing information directly from vaccinees, will offer quicker and more thorough insight into any side effects or safety issues that arise with COVID-19 vaccines compared with other vaccine safety monitoring methods.
Professor Saad Shakir, DSRU Director, said: “Creating new COVID-19 vaccines so quickly is a triumph for scientists. They have been subject to thorough evaluation of their efficacy and safety by the UK’s regulator, the MHRA. But the development process does not end now. Monitoring the safety and effectiveness of new products once they are being used in ‘real-life’ by the UK population is also an essential component.
“These ‘post-authorisation’ studies are even more important for new COVID-19 vaccines that have been fast-tracked through clinical trials. To offer the greatest protection to public health, these studies must be fully transparent, report quickly in as near real-time as possible and be conducted independently rather than by vaccine manufacturers.
“The public can then be reassured that the vaccine has not only be subjected to rigorous assessment by the UK’s regulator but remains under continuous monitoring so prompt action can be taken if any concerns arise.”
The DSRU is currently targeting anyone aged 40 – 50 who has either received their vaccine or expects to do so soon. However the study team is also keen to recruit people of any age who have received their first dose of the AstraZeneca vaccine within the last 6 weeks. The research unit is encouraging people from all four UK nations to take part whether or not they’ve experienced any symptoms after vaccination.
People can express their interest in taking part in the study before vaccination, or sign up within 6 weeks of receiving the vaccination, both via the study website goto.dsru.org/covid. All participants will be asked basic information about the vaccine and their health. They will then receive questionnaires at intervals for up to 18 months – the anticipated length of the study. A random sample of participants will also be asked questions regarding their quality of life in the months following their vaccination.
The DSRU research team will collate and study information provided by participants to explore whether any side effects seen in the study population are likely to be linked to the vaccine. The team will provide monthly updates to the pharmaceutical manufacturer and to the UK’s regulator, the Medicines and Healthcare products Regulatory Authority (MHRA). It will also provide a summary of the study results on its website and will publish results in scientific journals.
The DSRU has gathered a consortium of doctors, pharmacists and scientists from 12 UK universities and NHS trusts to help with the study. The DSRU is also conducting real-world studies on several other COVID-19 vaccines and treatments as they are authorised for use in the general population.
DSRU is an independent and internationally renowned research unit that monitors, studies and communicates the safety and risk management of medicines. For more information visit dsru.org.
The DSRU is now inviting anyone interested to either register their interest before they’re vaccinated, or sign up after receiving the AstraZeneca vaccine. Please visit goto.dsru.org/covid or call 0800 619 6222.
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