Preparation started to monitor the safety and efficacy COVID-19 vaccines

An European project has been started to prepare for the monitoring of the safety and efficacy of COVID-19 vaccines. This project aims to conduct preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice. This project, financed by the European Medicines Agency (EMA), is lead by Dutch researchers from the University Medical Centre Utrecht and the Utrecht University. A total of 22 European research centres are involved in this public-academic partnership.

The Netherlands Pharmacovigilance Centre Lareb will have an important role as the lead for creating a protocol in which the infrastructure and available (app) tools required for active safety surveillance of the vaccines, based on primary data collection through patients, are defined. An implementation plan, considering feasibility and governance aspects for an European collaborative safety monitoring, will be established as well.

The aim is, within the coming six months, to prepare European countries to effectively monitor the efficacy and safety of COVID-19 vaccines once they become available. First deliverables are planned for August 2020 with a final delivery by the end of the year.

Read the press release from the EMA here.