VAC4EU: A Pan-European Research Network for Collaborative Post-authorization Vaccine Safety and Benefit Monitoring: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: VAC4EU (Vaccine monitoring Collaboration for Europe) is a not-for profit international association with 24 member organizations specialised in the collaborative generation of real-world evidence on coverage, safety, and efficacy of vaccines in Europe. VAC4EU was established as a result of the IMI-ADVANCE project with the aim to enable, coordinate and accelerate the creation of the best evidence at European level on vaccine effects. In the past two years, VAC4EU has proven preparedness and efficiency in designing post-authorization monitoring for COVID-19 vaccines responding to the requests of both the European Medicines Agency (EMA) and vaccine manufacturers Objective: To describe the VAC4EU organization, data, tools and the accomplishments made towards the generation of real-world evidence on vaccine benefit-risk evaluation. Methods: Not applicable. Results: Since its creation in October 2019, VAC4EU has established a large research network composed of 24 institutions from 9 European countries (BE, DE, DK, FR, IT, NL, NO, ES, UK) providing access to different health care data sources covering more than 150 million European citizens. VAC4EU has implemented a research infrastructure including a catalogue, a codemapper tool, a sharepoint, Github, digital research environment (DRE), a phenotype library of more than 100 variables with definitions and a Zenodo community to facilitate collaboration, transparency, and federated data analysis. VAC4EU has adopted the ConcePTION common data model as a basis for the structural harmonization of electronic health data, but it also allows for primary data collection. VAC4EU has consolidated its governance structure for implementation of pharmacovigilance studies on vaccines and successfully participated in four public tenders regarding vaccines safety and effectiveness launched by the European Medicines Agency (EMA) [1-3] as well as four required post-authorization safety studies on COVID-19 vaccines sponsored by vaccine manufacturers [4-8], and other studies promoted by the Global Vaccine Data Network. All protocols developed within VAC4EU are registered in the EU PAS register, and results are published in the open science VAC4EU Zenodo community. Conclusion: We know already from the H1N1 pandemic that collaboration is needed to study vaccine effects. This collaboration was designed and tested in the IMI-ADVANCE project and implemented in VAC4EU. VAC4EU has demonstrated readiness of its research framework making a key difference in COVID-19 vaccine monitoring in Europe. Research and public health organizations can join the initiative.