The US FDA is expanding access and development for two investigational blood-based therapies for COVID-19—convalescent plasma and hyperimmune globulin. The therapies are derived from the antibody-rich blood of patients who have recovered from coronavirus.
According to the FDA, limited data and experiences from China suggest these therapies have the potential to lessen the severity or shorten the length of COVID-19 illness. Expanded access to the therapies via clinical trials will build on this limited data, the agency says.
The FDA is also asking for plasma donations from COVID-19 patients who have fully recovered for at least two weeks. Donations could potentially help save the lives of up to four patients, the FDA said.
Contact the American Red Cross website (www.redcrossblood.org/plasma4covid) or contact their local blood donor or plasma collection center.
The FDA is facilitating access to convalescent plasma for treating COVID-19 using multiple pathways, including an emergency investigational new drug application (eIND) process. In addition, clinical trials are being conducted at academic institutions to rigorously evaluate the safety and efficacy of convalescent plasma.
However, not every patient has access to these clinical trials, and the FDA has spearheaded a partnership with the Mayo Clinic and American Red Cross to provide convalescent plasma to these patients groups. This program will be run by the Mayo Clinic with plasma collection and distribution from the American Red Cross for use in patients across the country.
The FDA anticipates that this collaborative effort will be able to move thousands of units of plasma to the patients who need them in the coming weeks.
Hyperimmune globulin is a biological product manufactured from convalescent plasma. The FDA is helping to coordinate a study of hyperimmune globulin that will be conducted by the NIH’s National Institute of Allergy and Infectious Diseases.
“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,” said FDA commissioner Stephen M. Hahn. “This is certainly a great example of how we can all come together to take swift action to help the American people during a crisis.”