European Commission Proposes Strategy for COVID-19 Vaccines, DrugsBy
The European Commission (EC) has proposed a strategy to support the development and availability of COVID-19 vaccines and treatments in the European Union (EU), which includes funding for research and manufacturing.
The EU Vaccines Strategy covers the full lifecycle of medicines: from research, development, and manufacturing to procurement and deployment. The strategy includes actions and targets, including a plan to authorize three new therapeutics to treat COVID-19 by October 2021 and possibly two more by the end of 2021.
The plan calls for a EUR 90-million ($109 million) investment in population studies and clinical trials to establish links between risk factors and health outcomes to further inform public health policy and clinical management, including for long-COVID patients. Additionally, the EC will set up a “therapeutics innovation booster” by July 2021 to support therapeutics from preclinical research to market authorization.
The plan also calls for a EUR 5-million ($6-million) investment under the EU4Health program, a dedicated funding program for 2021-2027 for building resilient health systems in the EU, to generate safety data. It will also provide EU countries with financial support of EUR 2 million ($2.4 million) under the EU4Health 2021 work program for expedited and coordinated assessments to facilitate approval of clinical trials. The plan also will explore how to support developers of therapeutics to build capacity to produce high-grade material for clinical trials.
Additionally, EUR 5-million ($6-million) will be invested to map therapeutics and diagnostics to analyze development phases, production capacities, and supply chains, including possible bottlenecks and establish a broader portfolio of 10 potential COVID-19 therapeutics and identify five of the most promising ones by June 2021.
The strategy also calls for EUR 40 million ($48.5 million) to fund preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fast-track Action Boost (FAB) project, an European program for integration of labor forces, which in turn will become over time an important asset for the European Health Emergency Preparedness and Response Authority (HERA), an agency to be created in the EU to improve Europe’s capacity and readiness to respond to cross-border health threats and emergencies.
The plan also calls for joint procurement and financing measures, which includes launching new contracts for the purchase of authorized therapeutics by the end of the year (2021) and securing faster access to medicines with shorter administrative deadlines.
The EC will draw up a portfolio of 10 potential COVID-19 therapeutics and by June 2021, identify the five most promising ones. It will organize matchmaking events for industrial actors involved in therapeutics to ensure enough production capacity and swift manufacturing. New authorizations, rolling reviews, and joint procurement contracts will be up and running before the end of the year (2021), according to the EC.
The therapeutics innovation booster, matchmaking events, and preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fab project, will feed into the HERA, for which a proposal is due later in the year (2021). The pilot project on access to health data will feed into the European Health Data Space proposal that is expected later this year (2021).
The Strategy on COVID-19 therapeutics complements the EU Strategy for COVID-19 vaccines from June 2020 and builds on ongoing work by the European Medicines Agency and the EC to support research, development, manufacturing and deployment of therapeutics.
Source: European Commission