Monitoring and assessing vaccine safety: a European perspective

Abstract

The success of vaccination programs is an uncontroversial reality – in Europe as well as worldwide. On the other hand, the perceived risk of adverse events in the general public is the most important threat for implementing successful vaccination programs in Europe. For this reason, monitoring and assessing vaccine safety is a priority for public health. Vaccine safety is assessed both before and after vaccine authorization. In postmarketing settings, different activities related to vaccine safety usually involve several different stakeholders. In 2005, a new EU agency, the European Centre for Disease Prevention and Control, was established with the aim to strengthen Europe’s defences against infectious diseases. Implementing stable links between different stakeholders and defining clear roles in the EU is paramount in order to provide optimal and transparent information on adverse reactions following immunization, with the final goal of increasing compliance to safe and effective vaccination programs.

Keywords::

• adverse effects
• European Union
• immunization program
• vaccination
• vaccine safety

Acknowledgements

The authors wish to give special thanks to John Ryan (European Commission) and Xavier Kurz (European Medicines Agency) for their valuable comments, and J Todd Weber (US CDC) for reviewing the manuscript.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.