Establishment of a Network of Ever-warm Production Capacities for Vaccines and Therapeutics manufacturing (EU FAB)

Kort beskrivelse

The COVID-19 pandemic showed the challenges for existing EU facilities to ramp-up their production. Thus, as part of strengthening the Health Union, for future health crises the EU must be better prepared and guarantee quicker access to sufficient manufacturing capacities for vaccines and therapeutics, to respond to EU needs and to fulfil our global obligations. As announced in the Communication on the European Health Emergency Preparedness and Response Authority on 16 September 2021, the Commission will set-up EU FAB, a network of ever-warm, single and/or multi-technology production capacities for vaccines and therapeutics. It will ensure heightened supply in case of a surge in demand due to public health emergencies, by reducing the time needed between development and industrial scale-up, and provide for solid supply chains thereto. If needed, access and use can be activated and made available. During ‘non-crisis’ times, these facilities are used for their regular activities. The aim of lot 1 is to award contracts to a number of economic operators for keeping part of their production capacity (single and/or multi-technology sites) at the disposal of EU FAB and, in case of its activation, for the production and supply of vaccines in the European Union. The contracts will ensure that EU FAB has a total EU production capacity of 700 million doses, half of which would need to be made available within the first 6 months following activation of EU FAB. The economic operators need to ensure the entire production chain of the finished product, including fill and finish and packaging of vaccines, according to the specifications of the marketing authorisations and manufacturing authorisations. In addition, manufacturers have to demonstrate access to sufficient quantities of all necessary critical raw materials and consumables, which they will need in order to produce the doses of vaccines to be agreed. The facilities have to be operational during non-crisis time, during which they can be used for their regular activities. In case of activation of EU FAB, they have to be capable to produce and supply the doses of vaccines to be agreed, upon request and within the requested timeframe. The procurement documents will be made available when the call is launched.