EMA Interim Guidance

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 active or passive enhanced safety surveillance studies on seasonal flu vaccines each year.

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.

Flu Vaccine Feedback Study

Read the published paper

Enhanced passive method

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 our 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 the paper, published in January 2016.