IDIAPJGol has participated and contributed, through Vaccine monitoring Collaboration for Europe (VAC4EU), to the study Report on pharmacovigilance tasks, which summarizes the work carried out by the EU Pharmacovigilance Network between January 2019 and December 2022 to ensure the safety of all medicines authorized in the EU, including vaccines and therapeutics against COVID-19. The report also describes the main improvements introduced to the EU pharmacovigilance system during this period and critically reflects on the key areas that will need further strengthening in the coming period.

The study’s conclusions indicate that the EU pharmacovigilance system has consolidated and improved over the last 10 years. Various measures have been taken to improve the effectiveness of pharmacovigilance activities and regulatory actions. Emphasis has been placed on the evaluation of risk minimization measures (RMMs), and initiatives have been developed to improve their implementation. Support has also been given to the use of real-world data for decision-making. Nevertheless, some limitations have been identified, and work will be done to improve study designs and adverse reaction monitoring tools. Overall, the EU pharmacovigilance system is better prepared to face future public health crises, such as the COVID-19 pandemic.

The VAC4EU team at IDIAP Jordi Gol is composed of Felipe Villalobos, María Giner-Soriano, Carles Vilaplana-Carnerero, Meritxell Pallejà-Millán, Carlo Alberto Bissacco, Dan Ouchi, María Aragón, Elena Segundo, and Clara Rodríguez.

Vaccine monitoring Collaboration for Europe (VAC4EU) is an international non-profit association that enables the generation of robust and timely evidence on vaccine effects collaboratively across Europe. IDIAPJGol is a member of this association and currently participates, along with other European institutions, in a series of studies on the safety and effectiveness of COVID-19 vaccines, using data from SIDIAP and the ConcePTION Common Data Model.