017 “Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza, Lot 2”

In 2018, the Council recommendation on Strengthened Cooperation against Vaccine-preventable Diseases (2018/C 466/01) called on the European Commission to work with the Member States with the support of the European Medicines Agency (EMA) and in cooperation with ECDC to ‘continuously monitor the benefits and risks of vaccines and vaccinations at EU level including through post-marketing authorisation studies’.
In 2020, the European Commission emphasised the importance of continuously monitoring the safety and effectiveness of vaccines in EU/EEA and called on ECDC and EMA to develop a structured post-authorisation monitoring platform for vaccines, prioritising COVID-19 vaccines. In November 2020, the European Commission proposed to the European Parliament and the Council of the EU an addition to the EMA’s and ECDC’s mandates as part of the European Health Union package, proposing to empower the two agencies to jointly coordinate independent vaccine post-authorisation studies, and proposing additional EU funds to conduct such studies.
As a result, at the end of 2020, utilising the lessons learned from other vaccine effectiveness studies, ECDC started building infrastructure to perform COVID-19 vaccine effectiveness studies. The infrastructure aims to build a system to regularly monitor vaccine effectiveness and perform studies in different settings, and depending on the setting, to provide information on different outcomes (severe disease, moderate disease, transmission, etc). The studies have been embedded in a project called VEBIS (Vaccine Effectiveness, Burden and Impact Studies). The multi-country approach of the effectiveness studies is also one of the key features that characterizes the studies, with a foreseen progressive inclusion of more countries over time.