PEOPLE in Wales receiving a coronavirus vaccine are being encouraged to take part in a new safety study run by the UK's independent Drug Safety Research Unit (DSRU).

The DSRU is starting to monitor the safety of the Oxford/AstraZeneca vaccine and wants to enrol at least 10,000 patients, who will be contacted at regular intervals after receiving their jab and asked if they are experiencing any possible side effects.

The study is one of a series of measures to help protect the public by ensuring any adverse effects are quickly recognised and acted upon.

It is expected that the DSRU’s approach, sourcing information directly from those who have received the vaccine, will offer quicker and more thorough insight into side effects or safety issues that arise with the vaccines, compared with other vaccine safety monitoring methods.

“Creating new Covid-19 vaccines so quickly is a triumph for scientists," said DSRU director Professor Saad Shakir.

"They have been subject to thorough evaluation of their efficacy and safety by the UK’s regulator, the MHRA (Medicines and Healthcare products Regulatory Agency).

"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 been 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 recruiting people from the Phase one vaccination group, which includes all those aged over 50, health and social care workers, and people who are clinically extremely vulnerable.

The research unit is encouraging people from all four UK nations to take part, whether or not they have experienced any symptoms after vaccination.

People can express their interest in taking part in the study before vaccination, or sign up within 28 days of receiving the vaccination.

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 vaccine manufacturer and to the MHRA. It will also summarise the study results on its website, and 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. It expects to conduct several active surveillance safety studies on various Covid-19 vaccines and treatments as they are authorised for use in the general population.

It is an independent academic unit set up 40 years ago, not a pharmaceutical company or government agency, and has studied flu vaccine safety each year since 2014 using a similar technique.

Anyone interested may register their interest before their vaccination, or sign up after receiving the Oxford/AstraZeneca vaccine. Visit or call 0800 619 6222.