ADVANCE: towards near-real time monitoring of vaccination coverage, benefits and risks using European electronic health record databases

Background: The Accelerated Development of VAccine beNefit–risk Collaboration in Europe (ADVANCE) is a public‐private collaboration aiming to develop and test a system for near real‐time (NRT) benefit–risk (B/R) monitoring of vaccines using electronic health record (eHR) databases in Europe. Objectives: To test the feasibility of NRT monitoring (NRTM) of vaccination coverage, benefits and risks based on multiple eHR databases in Europe (EU), using acellular pertussis vaccination in children (< 6 years) as test case. Methods: Among participating databases in the ADVANCE consortium, which expressed interest in this NRTM study based on a preliminary qualitative feasibility assessment, a dynamic cohort study was conducted containing two distinct observation periods: a first period (Jan 2014 ‐ Feb 2018) to establish a baseline and a second period (March 2018–May 2018) to test the actual feasibility of NRTM of vaccination coverage, benefits and risks. The events were dose‐specific vaccinations (coverage), pertussis (benefit) and febrile convulsions, fever, hypotonic‐hyporesponsive episodes, somnolence and persistent crying (risks). Data latencies, differences in time between the date of diagnosis and the data release date, were derived from consecutive data extracts and an interactive web‐application was developed for visual monitoring. Five databases from 4 European countries (Denmark: SSI; Italy: ARS, ATSVP; Spain: SIDIAP and UK: RCGP RSCS) participated in this study. Results: Five databases provided baseline data. Three databases (SSI, ATSVP and RCGP RSC) successfully provided weekly data extractions for a period of three months. The median data latency was 2 (SSI), 2 (ATSVP) and 1 week (RCGP RSC) for vaccinations and varied between 2 weeks and 3 month for the majority of benefit and risk events, depending on type of event and database. ARS and SIDIAP did not obtain approval in time to perform repeated data extractions. Conclusions: This test case demonstrated that visual NRTM of vaccine benefits and risks is possible with multiple EU eHR databases. Getting the required approvals is a potential barrier.