Post-market safety study of Oxford Covid-19 vaccine begins

A study monitoring the safety of the Oxford/AstraZeneca Covid-19 vaccine has started to enrol patients.

The Drug Safety Research Unit (DSRU) in Southampton will now begin to collect near ‘real-time’ data from patients receiving the jabs. The study will enrol at least 10,000 patients who will be contacted at regular intervals after receiving the Oxford/AstraZeneca vaccine. In order to recognise any adverse events from the vaccine, the patients will be asked whether they are experiencing any side effects.

The DSRU hopes that by sourcing information directly from vaccinees, it can offer quicker and more thorough insight into any potential safety issues. The team will provide monthly updates to AstraZeneca as well as the Medicines and Healthcare products Regulatory Agency (MHRA).

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 study will recruit people from the Phase I vaccination group, which includes those aged over 50 health and social care workers and people who are clinically extremely vulnerable.

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.