Health and vaccine safety research using real-world data (RWD)

The use of real-world data (RWD) for health research is becoming established as a valuable source for getting insight and evidence in the actual day-to-day context. Currently, massive amounts of data are generated on a daily basis. Being able to use it and achieve trustworthy evidence, has become a priority for the EU Commission. RWD studies bring the opportunity to complement results from randomized controlled trials (RCT) by addressing main limitations of RCTs. RWD is being used to perform activities such as designing and evaluating patient-centered primary care models, pharmacovigilance studies, characterization of patient profiles with multimorbidity, elucidate chronic-disease association patterns and determinants of their evolution in the population. EpiChron is an epidemiological research group from the Spanish National Health System, with main focus on the study and management of multimorbidity and chronicity. Besides, the group is involved in the generation of real-world evidence for medical products, their post-authorization safety and efficacy. In this webinar, Alejandro Santos Mejías introduces the RWD-based research conducted by EpiChron with a focus on a post conditional approval active surveillance study of the Pfizer-BioNTech COVID-19 vaccine conducted within the framework of the Vaccine monitoring Collaboration for Europe (VAC4EU). VAC4EU is a non-profit European network with 25 associated members from 9 different countries whose goal is the generation of real-world evidence on coverage, safety, and efficiency of any kind of vaccines in Europe.