BARDA is partnering with the Center for Innovation in Advanced Development and Manufacturing (CIADM) at 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 the manufacture of the therapeutic for clinical evaluation in COVID-19 patients later this year.
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 BioSolutions 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 BioSolutions 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.
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
In June of 2012, Biomedical Advanced Research and Development Authority (BARDA) and Emergent entered a public-private partnership to establish our Center for Innovation in Advanced Development and Manufacturing (CIADM). The CIADM facilitates advanced development of chemical, biological, radiological, and nuclear (CBRN) medical countermeasures and ensures domestic manufacturing surge capacity to address the U.S. government's preparedness priorities and needs. Emergent's CIADM has been awarded four task orders by BARDA to develop Ebola and Marburg therapeutics and a Zika vaccine. For more information visit www.emergentbiosolutions.com.