FDA looks to develop new COVID-19 therapies based on blood donations from survivors of the virus

The U.S. Food and Drug Administration (FDA) has stepped in to fast-track development of and access to two more investigational therapies for COVID-19 based on convalescent plasma and hyperimmune globulin from human blood.

By using blood donated from those who have recovered from the SARS-CoV-2 virus, which causes COVID-19, the FDA hopes to find antibody-rich products that could be administered to those currently fighting the disease. This would purely be a matter of evaluation at this point, of course — any data suggesting either such plasma of globulin could help fight COVID-19 is limited.

“This is an important area of research — the use of products made from a recovered patient’s blood to potentially treat COVID-19 in those affected by this illness,” FDA Commissioner Stephen Hahn said. “The FDA remains actively engaged with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to prevent and treat this novel virus – both evaluating the safety and efficacy of potential therapies and facilitating emergency access for patients, as appropriate. The FDA had played a key role in organizing a partnership between industry, academic institutions, and government agencies to facilitate expanded access to convalescent plasma.”

Health and Human Services Secretary Alex Azar touted the effort as the latest bit of cooperation between the public and private sector, and representative of the FDA hunting new ways to gather efficacy data while moving products to market.

The limited data currently used to make these calls comes from China, where researchers in non-peer reviewed studies saw results in small study samples — just 10 severely infected patients were tested. Those researchers called for further investigation in larger, well-controlled trials, which is essentially what the FDA is doing, through an emergency investigational new drug application process. It is also facilitating clinical trials at academic institutions.

The FDA has organized industry, academic, and government partners into a means of providing convalescent plasma to patients across the country, with the Mayo Clinic as lead institution and collection in the hands of the American Red Cross. Separately, a study of hyperimmune globulin will be conducted by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Any patient who has fully recovered from COVID-19 for at least two weeks is encouraged to donate plasma.