The EHDEN and ConcePTION projects plus the ADVANCE/VAC4EU initiative will help the European Medicines Agency (EMA) gather real world data on COVID-19 vaccines and treatments once they are approved and being used in day-to-day clinical practice.
Researchers worldwide are currently racing to develop vaccines and treatments against COVID-19, the disease caused by the coronavirus SARS-CoV-2. Once a medicine or vaccine has demonstrated its safety and efficacy in clinical trials, medicines regulators like the EMA will grant a marketing authorisation. This means that the product can be used more widely as part of normal clinical practice. However, as with any new medicine or vaccine, medicines regulators will keep gathering data on its safety and efficacy in the ‘real world’.
Now, the EMA has set up an infrastructure to facilitate the monitoring of COVID-19 vaccines and treatments in the real world setting, and two ongoing IMI projects are heavily involved. In addition, an international association that was created by an earlier IMI project is contributing to the work.
IMI’s EHDEN project is converting healthcare records from organisations across Europe to a common data model, and linking them up to create a federated data network which still preserves patients’ privacy. It is already working with 25 data partners across Europe, to help them map COVID-19 data to a common data model.
Now, it is set to collaborate with the EMA on the creation of a framework for multicentre cohort studies on the use of medicines in COVID-19 patients. This will entail the identification of large national cohorts of COVID-19 patients and appropriate comparator groups, the development of a study protocol template for multinational studies, and the establishment of a collaborative framework for researchers.
‘This is precisely what EHDEN was set up for: creating an international, open science network in Europe, based on a common data model, standardised analytics, tools, and methodologies,’ said EHDEN Coordinator Peter Rijnbeek of Erasmus University Medical Centre, Rotterdam.
The goal of IMI’s ConcePTION project is to create trusted biomedical ecosystem capable of providing evidence-based information on the safety of medications during pregnancy and breastfeeding in an efficient, systematic and ethically responsible way. It will collaborate with the EMA on a project that will collect data on the impact of COVID-19 in pregnancy and will follow up the baby to monitor long-term outcomes in order to guide decision-making about vaccine indications, vaccination policies and treatment options for COVID-19 in pregnant women.
‘This new initiative is fully aligned with ConcePTION’s goal of generating reliable information that will allow pregnant and breastfeeding women and their healthcare providers to make the right decisions for their care,’ said Ida Niklson of Novartis, one of the ConcePTION project leaders.
VAC4EU (Vaccine Monitoring Collaboration for Europe) is set to work with the EMA to prepare for the monitoring of the benefits and risks of COVID-19 vaccines in Europe. VAC4EU was born out of IMI’s ADVANCE project, which drew on lessons learnt from the 2009 swine flu pandemic to create an ecosystem for monitoring vaccine benefits and risks.
‘It is amazing that the 2009 pandemic led to the ADVANCE project and that the system was designed and tested, and 10 years later it is ready to allow for monitoring the coverage, benefits and risks of COVID-19 vaccines in Europe,’ said VAC4EU president Miriam Sturkenboom of University Medical Center Utrecht.
‘The inclusion of EHDEN, ConcePTION and VAC4EU in the EMA’s work is testament not only to their scientific excellence but to their ability to adapt to the challenges posed by the COVID-19 pandemic,’ said IMI Executive Director Pierre Meulien. ‘I am confident that the projects will make a valuable contribution to this important initiative which is a key part of the global fight against the disease.’
The outcomes of the projects will feed into the work of EMA’s COVID-19 EMA pandemic Task Force (COVID-ETF) and EMA’s scientific committees, to ensure that the evidence is translated into scientific opinions on the optimal use of the medicines and vaccines concerned.