Clinical Trial Readiness through the Establishment of a Pilot Filovirus Investigational Vaccine Reserve

Oryginalny opis TED

This call for tenders aims to ensure clinical trial preparedness for Filovirus outbreaks through the establishment of an EU-based reserve of investigational vaccines as a critical preparedness measure, given the sporadic yet high-consequence nature of these pathogens. Specifically, the call aims to establish, pilot and maintain an investigational reserve of Filovirus candidate vaccines against Ebola Sudan (SUDV), Ebola Bundibugyo (BDBV) and/or Marburg (MARV), which – in case of an outbreak – could be used to advance their development by embedding them in outbreak-associated clinical trials, facilitated through international agreements and frameworks to support such preparedness. These provisions will allow for the rapid deployment of candidate vaccines for their later-stage development. Tenderers will further have to ensure the rapid deployment of the investigational doses, subject to specific conditions being met (such as the occurrence of an outbreak and the expressed consent of the Contracting Authority).