Study assessing Covid-19 vaccine side effects to launch in UK

The Drug Safety Research Unit (DSRU) will recruit 3,000 people across England and Wales to study the effects of all Covid-19 vaccines.

The DSRU is leading the UK arm of a European study assessing side effects from all approved Covid-19 vaccines.

People across England and Wales will be asked numerous questions over the duration of six months to capture information about the vaccines and any adverse events they may have caused. Data will be collected in near real time and will assess things like the incidence rates of adverse drug reactions and how frequently they occurred.

The data, which will be anonymised, will be shared and analysed alongside comparative data from other European countries to assess any emerging trends around safety and side effects.

Professor Saad Shakir, director of the DSRU, said: “Pooling data from several countries gives us a much larger and more diverse sample to analyse, and this will help us uncover rare adverse reactions faster than if we each acted alone.

“Covid-19 vaccines have already gone through stringent safety testing but the rarest side effects will only appear when huge numbers of people start using them, something that’s just not possible in clinical trials.

“This study is an important addition to existing spontaneous reporting systems for adverse effects from Covid-19 vaccines, and will help regulators make informed decisions about whether any risk minimisation measures are needed for specific groups of vaccinees.”

UK participants wanting to take part must register within two days of receiving their first vaccine. Then, they will complete a baseline questionnaire, followed by further questions about symptoms and side effects at regular intervals over six months. Data will be reported to regulators and pharmaceutical companies.  

Dutch pharmacovigilance centre, Lareb, is coordinating the study, which is funded by the European Medicines Agency.