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.
An example of an active surveillance study is the Flu Vaccine Feedback study conducted on the children’s intranasal flu vaccine in 2014. In the ‘active’ approach, we collected safety data by inviting parents or carers to complete a post-vaccination survey. For more information – see our video opposite or the published paper on this study.
In the last few years we have used an enhanced passive method for flu vaccine surveillance. In the enhanced ‘passive’ method, Safety Report Cards are handed out at the time of vaccination by immunisation staff to encourage reporting of side effects by vaccine recipients. Details of last season’s passive vaccine surveillance are available on this pdf presented at the International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in August 2018
Both of these methods have been successful because we can set them up rapidly with a network of general practitioners and vaccination nurses. They also allow us to monitor patterns of reported suspected adverse drug reactions from season to season.
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 2018-19 flu season and beyond. The DSRU is a not-for-profit organisation, which allows our study fees to be set at very reasonable levels.
Drug Safety. April 2016, Volume 39, Issue 4, pp 323–333