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. Full details 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 2016-2017 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.

For information about the DSRU’s current flu vaccine ESS, click here.

If you would like any further information about our experience or capabilities or to arrange an informal discussion please email Dr Liz Lynn, Head of Scientific and Educational Development, at: elizabeth.lynn@dsru.org.