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The Drug Safety Research Unit (DSRU) is an independent academic unit internationally respected for its work in Pharmacovigilance, Pharmacoepidemiology, Risk Management and Training for over 30 years.
In partnership with doctors in England, the DSRU, led by Director Professor Saad Shakir, aims to protect patients in primary and specialist care from unwanted adverse effects of newly marketed medicines using our unique methods of monitoring patients during the lifecycle of medicines.
We are delighted to announce the successful completion of our Flu Vaccine Feedback Study. This non-interventional cohort post authorisation safety (PASS) study was undertaken in order to satisfy guidance published by the EMA in 2014 on enhanced active safety surveillance for influenza vaccines. The aim of the study was to monitor the incidence of adverse events of interest (AEI) following vaccination with the nasal flu vaccine, Fluenz Tetra.
This was a short-term study, which was set up rapidly. Patients or their parents were invited to take part immediately after vaccination at GP surgeries or at some schools where vaccination took place as part of a pilot programme. Patients were recruited at many sites in order to quickly achieve the necessary cohorts. Once consent was provided, patients were invited to report AEIs within 14 days of vaccination using questionnaires either via the bespoke study website or by post. We submitted an expedited safety summary report within 8 weeks of study start and the final report has been presented to PRAC.
Now we have experience of conducting enhanced safety surveillance on one specific flu vaccine, we are keen to apply the methodology to other influenza vaccines that are offered to children and adults. We also believe we can extend our methods to other European countries.View our latest news