Inactive

As part of the Federal COVID-19 Response, the U.S. Government is establishing a new interagency COVID-19 serum biorepository that will allow for in vitro assessments of vaccine efficacy against newly ... As part of the Federal COVID-19 Response, the U.S. Government is establishing a new interagency COVID-19 serum biorepository that will allow for in vitro assessments of vaccine efficacy against newly emerging variants of SARS-CoV-2. In order to provide serum for the biorepository, there is an urgent need to source plasma from COVID-19-naïve subjects to have received a COVID-19 vaccine authorized for use under an Emergency Use Authorization (EUA) by the FDA. This acquisition seeks to identify qualified vendors who are capable of identifying, testing, and drawing plasma via plasmapheresis from patients who have been vaccinated. The work must be conducted under an IRB-approved protocol. The plasma collected must meet the U.S. government’s specifications as set forth in the requirements. The plasma will then be packaged, temporarily stored, and shipped to a vendor of the U.S. Government’s choice for processing into serum. Additional retain samples must also be collected, stored, and shipped to support additional testing. A quality audit of the facility may be warranted pre-award to ensure vendor capabilities and quality controls. See attached Combined Synopsis Solicitation for details.