New consortium of research institutions will coordinate vaccine trials in the European Union / The long-term goal is to strategically plan and carry out vaccine trials in all EU and EU-associated countries
The European Union is funding the establishment of the new vaccine research network VACCELERATE with a total of 12 million euros for three years. So far, 26 partner institutions from 21 European countries are involved in the network. The consortium is headed by the infectiologist Oliver Cornely at the University of Cologne and Cologne University Hospital.
Vaccine-induced immunity against SARS-CoV-2 is considered the most promising solution to combat the pandemic. To build long-term herd immunity in Europe, as many people as possible need to be vaccinated. There is a high demand for vaccine trials since there are still many questions regarding, among other things, safety, efficacy, and the adaptation of vaccines in the face of virus mutations. This research will be coordinated through the newly established pan-European research network VACCELERATE. The platform will plan and conduct clinical trials and act as a single point of contact for all stakeholders - from health authorities to pharmaceutical vaccine developers.
Project leader Oliver Cornely, infectiologist, Director of the Translational Research Chair at the CECAD Cluster of Excellence in Aging Research and Senior Physician at the Department of Internal Medicine I at Cologne University Hospital, said: ’VACCELERATE is designed as a pan-European backbone for a coordinated approach to vaccine research. We want to network facilities, pool expertise, and promote knowledge exchange among our currently 26 partners. Our goal is to plan and coordinate vaccine trials under one strategic scientific umbrella in all EU member states and other EU-associated countries.’ An important step in establishing the network is to map capacities for clinical trial sites and laboratory facilities to identify suitable sites for vaccine trials in Europe. Cornely added: ’VACCELERATE will serve as the pandemic preparedness network, providing a structure beyond the current coronavirus pandemic to rapidly and effectively test vaccine candidates across Europe.’
Currently, VACCELERATE will be used primarily to plan, facilitate, and network phase II and III coronavirus vaccine trials. Phase II trials test the safety, tolerability, and efficacy of a new vaccine, as well as dosage. Phase III trials must demonstrate the efficacy of a new compound in large populations. For this purpose, it is compared with a placebo (a dummy medication) via random administration to volunteers. An application for approval of the tested substance can only be submitted to the European Union after successful completion of phase III testing.
In addition, VACCELERATE will provide quality assurance training and coordinate access to laboratory sites essential for phase II and III clinical trials. A Europe-wide volunteer registry for rapid patient recruitment is already under development. A harmonized European approach to vaccine trials will enable the development of training standards, the coordination of laboratory support, the establishment of standardized laboratory methods (known as assays), and uniform study protocols. In addition, the platform will also serve in an advisory function to various stakeholders such as research institutions, pharmaceutical companies, and health authorities planning coronavirus vaccine trials in Europe.
To obtain valid research results, VACCELERATE will moreover enable harmonized data collection, open data exchange, and data pooling for improved analysis within the research platform. Through VACCELERATE, the European Union aims to increase its vaccine development capacity in the medium and long term.
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