The U.S. Food and Drug Administration continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19.
As part of the response to this pandemic, the agency 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.
“Under President Trump’s leadership, the FDA is launching a new national effort to bring blood-related therapies for COVID-19 to market as fast as possible,” said HHS Secretary Alex Azar. “The President’s all-of-America approach has driven unprecedented cooperation between the public and private sector, with the FDA finding new ways for the private sector to bring their products to patients while gathering the data we need on efficacy. Thanks to the hard work of FDA staff, scientists and physicians elsewhere, and support from NIH and BARDA, patients will be able to benefit from these promising new options in the coming weeks.”
“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. 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,” said FDA Commissioner Stephen M. Hahn, M.D. “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. 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.”
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 agency’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.
Notably, 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 agency 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.