“The observed heterogeneity between databases was more than I expected,” Prieto-Alhambra said. “As a consequence, vaccine safety surveillance should be conducted using the same database for both post-vaccine and background rates.”
This multinational network cohort study used deidentified electronic health records and health claims data, all of which were mapped to the OMOP common data model, from eight countries. All rates of adverse events, as well as the protocol and study codes, are available in the publication.
The study was developed and executed by the OHDSI community, a global, multi-stakeholder network that has more than 2,100 interdisciplinary researchers from six continents, as well as standardized health records for nearly 600 million unique patients around the world. The community strives to promote better health decisions and care through globally standardized health data, continuously developing large-scale analytics and a spirit of collaboration though open science.
OHDSI research on COVID-19 has resulted in published studies on the safety profile of hydroxychloroquine, the characteristics and outcomes of more than 34,000 COVID-19 patients, the varied therapies used around the world for COVID treatment, as well as several others in both peer-reviewed journals or on preprint servers.
ABOUT THIS STUDY
The study “Characterising the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: multinational network cohort study” was published as a Special Paper June 14 by The BMJ.
Xintong Li and Anna Ostropolets were joint lead authors for this study. There are 15 co-authors on this study.
Funding: This work was partially funded by the UK National Institute for Health Research (NIHR), European Medicines Agency, European Health Data and Evidence Network (EHDEN), US Food and Drug Administration CBER BEST initiative (75F40120D00039), and US National Library of Medicine (R01 LM006910). EHDEN has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 806968. The Innovative Medicines Initiative 2 Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The study funders had no role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript. This document expresses the opinion of the authors of the paper, and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.