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COVID convalescent plasma approved for those who are immunocompromised

January 16, 2025

Early in the COVID-19 pandemic, before vaccines, monoclonal antibodies, and antivirals, doctors turned to an old-school, Nobel-prize winning strategy—using the blood plasma of people who’ve recovered from an infection to treat those newly infected. Their research and perseverance has led the U.S. Food and Drug Administration (FDA) to approve the first convalescent plasma product for treating an infectious disease in FDA history.

Convalescent plasma refers to the liquid part of someone’s blood after they’ve been sick with an infectious disease. In this case, the treatment takes advantage of the antibodies developed by people who have recovered from COVID-19 to fight the same infection in others. It’s a form of passive immunization, like immunoglobulin (Ig) replacement therapy, that does not require any work on the part of the recipient’s immune system. 

OneBlood, a non-profit blood bank serving Florida, Georgia, and the Carolinas, is manufacturing the treatment. The organization worked with Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health, the Mayo Clinic, the Association for the Advancement of Blood & Biotherapies, the COVID-19 Convalescent Plasma Project, and the COVID-19 Serologic Studies Consortium to conduct the studies that led to its approval. While early studies showed that convalescent plasma had little effect in people hospitalized for COVID-19, later studies demonstrated that convalescent plasma is effective if it’s given before people develop severe COVID-19.

Developing convalescent plasma treatment

In May 2022, IDF spoke to Dr. Arturo Casadevall of Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine about his research on COVID-19 convalescent plasma, which proved pivotal to its approval.

FDA has approved OneBlood’s COVID-19 convalescent plasma to treat COVID-19 infections specifically in people who are immunocompromised in both out-patient and in-patient settings. Although OneBlood is a regional blood bank, healthcare providers at hospitals across the country can order convalescent plasma by contacting the organization. Because the antibodies in convalescent plasma primarily block the virus from infecting cells, OneBlood’s Chief Medical Officer, Rita Reik, M.D., said the treatment should be given as early as possible to be effective.

OneBlood is turning to its pool of blood donors to manufacture COVID-19 convalescent plasma. When someone donates whole blood, they answer questions about their health history, including whether they’ve had COVID-19. The OneBlood lab then tests their blood for antibody levels. If the donation has a high enough level of COVID-19 antibodies, OneBlood separates the plasma to be used as COVID-19 convalescent plasma. Unlike the Ig used in Ig replacement therapy, each unit of convalescent plasma comes from one donor’s blood.

“Units that pass all FDA-required testing are then labeled as high-titer COVID-19 convalescent plasma and available for hospitals to order,” said Reik.

COVID-19 convalescent plasma joins a suite of COVID preventions and treatments on the market. Unlike vaccines and the monoclonal antibody Pemgarda, it’s not approved to prevent COVID-19. However, it offers another option to people who are at high risk from the virus and may not be protected as well by COVID vaccines.

Asked about the possibility of addressing other infectious diseases, Reik said “OneBlood remains vigilant should future opportunities arise for other convalescent plasma products.”

This page contains general medical and/or legal information that cannot be applied safely to any individual case. Medical and/or legal knowledge and practice can change rapidly. Therefore, this page should not be used as a substitute for professional medical and/or legal advice. Additionally, links to other resources and websites are shared for informational purposes only and should not be considered an endorsement by the Immune Deficiency Foundation.