April 6, 2020Regulatory
As part of the response to COVID-19 pandemic, the FDA is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus. The products can be administered to individuals diagnosed with COVID-19. There are some limited data to suggest that convalescent plasma and hyperimmune globulin may have benefit in the COVID-19 illness. This is why evaluation of these therapies in the context of a clinical trial and expanded access program is so important.
Based on prior experience with respiratory viruses and on data that have emerged from China, these products have the potential to lessen the severity or shorten the length of illness caused by COVID-19. The FDA is facilitating access to convalescent plasma for treating COVID-19 using multiple pathways. The FDA's initial effort was focused on facilitating access to convalescent plasma for the treatment of COVID-19 disease through an emergency investigational new drug application (eIND) process. The FDA has provided information to help health care providers submit these applications to treat individual patients. The agency also is facilitating the conduct of well-controlled clinical trials at academic institutions to rigorously evaluate the safety and efficacy of convalescent plasma.
The FDA has led an effort, working collaboratively with our industry, academic, and government partners to develop and implement a protocol that will provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place. This will allow for a simplified process for providers that will help to ensure patient safety, while also allowing for the collection of needed information about product efficacy. In this partnership, the Mayo Clinic will serve as the lead institution for the program and the American Red Cross will help collect plasma and distribute it for use in patients across the country. The program was developed with funding from the Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services' Office of the Assistant Secretary of Preparedness and Response. 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.
The FDA is also working with industry and its government partners to accelerate the development and availability of hyperimmune globulin for investigation for the potential treatment COVID-19. 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 National Institute of Allergy and Infectious Diseases of the National Institutes of Health, as well as coordinating other efforts in this area. The FDA continues to provide advice, guidance, and technical assistance to help expedite the development of these products and intends to use regulatory flexibility in making these products and other critical medical countermeasures available to prevent and treat COVID-19.
People who have fully recovered from COVID-19 for at least two weeks are encouraged to consider donating plasma, which could potentially help save the lives of up to four patients. Those willing to donate are urged to visit the American Red Cross website at www.redcrossblood.org/plasma4covid or contact their local blood donor or plasma collection center.