Public Health Emergency - Leading a Nation Prepared
BARDA is currently collaborating with three entities on programs related to the use of convalescent plasma, which originates from plasma donated by individuals who have recovered from COVID-19, for use in hospitalized patients with COVID-19. The three entities BARDA is working with are the Mayo Clinic, the American Red Cross, and America’s Blood Centers. The product may be made available through an expanded access program or through a clinical trial.
On May 4, 2020, BARDA announced it had entered into a collaboration with Mayo Clinic to support an expanded access program to provide access to convalescent plasma for patients hospitalized with COVID-19.
Mayo Clinic is serving as the central Institutional Review Board (IRB) to oversee the expanded access program, which includes patients at hundreds of hospitals across the country. This approach allows for rapid access to the product.
On April 27,2020, BARDA announced it is supporting efforts by America’s Blood Centers to coordinate the collection and distribution of convalescent plasma for therapeutic use in treating hospitalized COVID-19 patients. BARDA and America’s Blood Centers are working closely with the U.S. Food and Drug Administration which is coordinating across the U.S. government on a unified effort to collect convalescent plasma for use as a treatment for COVID-19 patients and in clinical trials.
On April 15, 2020, BARDA announced it would partner with the American Red Cross on systems and procedures to recruit donors who have recovered from COVID-19. Through this collaboration, the American Red Cross will prepare procedures for the collection of plasma for investigational use in treating patients infected with COVID-19.
On April 7, 2020, BARDA announced it would work with DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (DoD-JPEO-CBRND) and Grifols. Under this agreement, Grifols will collect plasma through a network of more than 250 plasma donor centers in the United States. The collected plasma will be used to manufacture pathogen-inactivated convalescent plasma for clinical use in COVID-19 patients.
On May 1, 2020, FDA updated its guidance (originally issued in April 2020) to provide recommendations to healthcare providers, and investigators on the administration and study of convalescent plasma collected from individuals who have recovered from COVID-19.
BARDA is working closely with the FDA, which is coordinating across the U.S. government for a unified effort to collect convalescent plasma for use as a treatment for COVID-19 patients under an expanded access protocol and in clinical trials.
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