Both normal source plasma donations, from healthy individuals, and convalescent plasma donations, from individuals who have recovered from COVID-19, are still needed to fight COVID-19 and the many non-COVID-19 conditions (e.g., immune deficiencies and blood clotting disorders) for which plasma protein therapies are ordinarily used.
Based on new scientific evidence under this EUA, the FDA authorizes only the use of high-titer convalescent plasma, for the treatment via transfusion of hospitalized patients with COVID-19, early in the course of disease, and those hospitalized with impaired humoral immunity.2 The use of low-titer convalescent plasma is no longer authorized under this EUA. Research on hyperimmune SARS-CoV-2 specific immunoglobulin therapies is however still ongoing.
Collection of source plasma for the development of plasma-derived therapies
Source Plasma donation is an option available to any healthy person who meets donor eligibility criteria. Past COVID infection does not preclude individuals from donating Source Plasma if donors continue to meet all eligibility criteria. Source Plasma collected via a process called plasmapheresis at more than 900 Source Plasma donation centers in the U.S. and EU is never used for transfusion. Instead, Source Plasma donations undergo a complex manufacturing process that can take 7-12 months to become lifesaving plasma protein therapies for patients living with a range of rare, serious, and sometimes life-threatening conditions, including immune deficiencies, immune-mediated peripheral neuropathies, hereditary angioedema, alpha 1-antitrypsin deficiencies, hemophilia, and other bleeding disorders.
Source Plasma donations have declined since the outset of the COVID-19 pandemic, and PPTA has been squarely focused on raising awareness of the urgent need for healthy and qualified individuals to donate their plasma. Please visit www.donatingplasma.org to learn more and to find a donation center near you.
1 The United States Food and Drug Administration. Letter of Authorization. Reissuance of COVID-19 convalescent plasma for the treatment of hospitalized patients with Coronavirus Disease 2019 (COVID-19). February 4, 2021. Available online: Letter of Authorization, Reissuance of Convalescent Plasma EUA February 4, 2021 (fda.gov))
2 Ibid.
Created on February 10 2021.