Cohort Monitoring of the Safety of COVID-19 Vaccines
Research type
Research Study
Full title
Cohort Monitoring of the Safety of COVID-19 vaccines
IRAS ID
296959
Contact name
Saad Shakir
Contact email
Sponsor organisation
Drug Safety Research Unit
Clinicaltrials.gov Identifier
EUPAS39798, EU PAS Register
Duration of Study in the UK
2 years, 4 months, 0 days
Research summary
This is the UK arm of a European study for intensive monitoring of adverse reactions (“cohort monitoring”) for COVID-19 vaccines. The pan-European cohort monitoring system will be consistent as much as possible across European nations in terms of data collection, data analysis, study populations and the vaccines monitored. The study will enable the collection of patient-reported safety data in near real time and will generate incidence rates of adverse drug reactions (ADRs) (i.e. the frequency of ADRs over time). The study is an important addition to existing spontaneous reporting systems for signal detection.
Study participants will be recruited before or at the point of receiving a COVID-19 vaccine at vaccination sites in the UK. Participants will be invited to use an English language web app to find out about the study and to provide consent if they wish to take part. Consented vaccinees will be asked to complete questionnaires via the web app at the time of registering, and then at 1, 3, 13, 16, 20 and 26 weeks after the first dose of vaccine is received. The exact timing of the sending of the third questionnaire will depend on the vaccination interval between two doses.
Any suspected adverse reactions reported by participants will be recorded by trained staff, and serious adverse reactions or other reactions that need medical clarification will be assessed by a qualified assessor. ADR incidence rates within the vaccinated cohort will be reported to the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the other researchers within Europe. Reports will be sent cumulatively every month, overall and for the different vaccine brands, gender and age groups. A summary of anonymised study results will be published both in a peer-reviewed journal and on our website.REC name
London - Brent Research Ethics Committee
REC reference
21/HRA/2077
Date of REC Opinion
27 May 2021
REC opinion
Favourable Opinion