The Biomedical Advanced Research and Development Authority (BARDA) is partnering with Emergent BioSolutions to develop COVID-19 Human Immune Globulin (HIG) for clinical evaluation as a potential therapeutic for COVID-19. BARDA’s funding will support the collection of plasma and manufacturing the product at the Emergent Center for Innovation in Advanced Development and Manufacturing (CIADM) in Baltimore, Maryland.
Currently, there are no FDA-approved therapeutics for the treatment of COVID-19. New therapeutics are urgently needed as treatments for patients suffering from COVID-19. The treatment will be based on plasma donated from patients who have recovered from COVID-19. This plasma contains antibodies that may help other patients with COVID-19 recover more quickly than the body could on its own. Emergent is working with the National Institutes of Allergy and Infectious Diseases, part of the National Institutes of Health, to plan for clinical trials of the COVID-19 HIG.
Emergent’s facility in Baltimore is part of BARDA’s CIADM network; the network supports the country's advanced development and manufacturing requirements in preparing for and responding to national health security threats. Development and manufacturing of a COVID-19 therapeutic marks the first time a CIADM has been used in a pandemic response. The CIADM network was built after the 2009 Influenza A (H1N1) pandemic to support medical countermeasure development and augment U.S. vaccine manufacturing capacity.
BARDA will provide $14.5 million toward the development and manufacturing of the therapeutic for use in clinical trials, and could provide up to approximately $22 million for additional development activities.
This award is one component of BARDA’s Rapidly-Expanding COVID-19 Medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
Read more: https://medicalcountermeasures.gov/newsroom/2020/emergent-plasma/