The Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (DoD-JPEO-CBRND) will collaborate with Spanish company Grifols to make available potentially life-saving COVID-19 treatments that use convalescent plasma or hyperimmune globulin.
Convalescent plasma is a blood product donated by patients that have recovered from COVID-19; the antibodies contained within the donated blood can be used as a treatment for patients still suffering from COVID-19. The antibodies also can be concentrated to produce hyperimmune globulin, a therapeutic product that is more uniform, allows for more flexibility in terms of dosing, and simplifies logistics administering the treatment.
Currently, there are no FDA-approved treatments for COVID-19. New therapeutic treatments, including convalescent plasma and hyperimmune globulin, are urgently needed for patients suffering from COVID-19. The FDA recently approved the use of convalescent plasma for COVID-19 treatment under an emergency investigational new drug protocol. (https://federallabs.org/news/fda-allows-investigational-use-of-covid-19-...) BARDA is also partnering with Emergent BioSolutions to develop a human immune globulin therapy for COVID-19. (https://federallabs.org/news/barda-emergent-partner-on-plasma-based-covi...)
Barcelona-based Grifols is currently part of the JPEO-CBRND’s Medical CBRN Development Consortium. BARDA and JPEO-CBRND are partnering through an interagency agreement to support the project, with BARDA providing $12.7 million. With BARDA’s project support, leveraging a separate partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, Grifols will collect plasma through a network of more than 250 plasma donor centers in the United States. Grifols then will manufacture both convalescent plasma and hyperimmune globulin ready for clinical use. The products are intended for testing in controlled clinical trials to evaluate their safety and efficacy in treating COVID-19 patients.