FDA Coordinates Nationwide Effort on Blood-Based Therapies for COVID-19

The FDA is promoting a nationwide effort to investigate two blood-based therapies for treatment of COVID-19.

Convalescent plasma and hyperimmune globin are antibody-rich blood products made from blood donated by recovered COVID-19 patients. Recent data from China suggest that they could lessen the severity or shorten the length of illness caused by the disease.

The FDA has created a protocol for providing convalescent plasma to patients who don’t have access to clinical trials, developed with funding from the Biomedical Advanced Research and Development Authority (BARDA).

The Mayo Clinic is the lead institution for the program and the American Red Cross will help collect and distribute plasma. The agency expects to move thousands of units of plasma to patients in the coming weeks.

In addition, the FDA is helping to coordinate a clinical trial of hyperimmune globulin as a potential COVID-19 treatment. The trial will be conducted by the National Institutes of Allergy and Infectious Diseases.

Drugmakers have also been working on blood-based therapies for COVID-19. Emergent BioSolutions has received $14.5 million from BARDA to support the development of a plasma-derived COVID-19 treatment candidate. Amgen and Adaptive Biotechnologies are also collaborating to develop an antibody therapy to either prevent or treat the disease. — Jordan Williams