Enhanced safety surveillance on seasonal flu vaccines
Since the publication in April 2014 of EMA interim guidance detailing the requirement for enhanced safety surveillance (ESS) on seasonal flu vaccines, the DSRU has conducted both active and passive enhanced safety surveillance studies on seasonal flu vaccines.
The studies have been successful because we set them up rapidly and established a network of general practitioners and vaccination nurses. We ensured that we recruited enough patients to obtain data by questionnaire in a short time frame, allowing us to submit the first report within weeks of study start. The final study report was submitted to PRAC a few weeks later.
Details of our passive ESS are available on this pdf presented at the International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in August 2016:
Details of our active ESS are available in this paper, published in January 2016.
This short video provides further information:
With this experience, the DSRU is well positioned to offer enhanced safety surveillance to satisfy EMA requirements for the 2017-2018 flu season and beyond. The DSRU is a not-for-profit organisation, which allows our study fees to be set at very reasonable levels. We are aware of the recommendations of Vaccines Europe with regard to enhanced safety surveillance of flu vaccines.
Drug Safety. April 2016, Volume 39, Issue 4, pp 323–333