Convalescent plasma is collected from people who have recovered from COVID-19 and contains antibodies that may treat people infected with the virus.
The FDA’s emergency authorization allows it to be used in hospitalized patients with confirmed or suspected COVID-19. The agency said that based on clinical trials, the known and potential benefits of convalescent plasma outweigh the known and potential risks.
“We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said FDA Commissioner Stephen Hahn, MD. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
The FDA said convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 in some hospitalized patients. But continuing clinical trials is critical to definitively determine if it is safe and effective, the agency said.
HHS Secretary Alex Azar encouraged people who have recovered from COVID-19 to consider donating convalescent plasma.
More than 70,000 patients have been treated with plasma, the FDA said. Possible side effects of COVID-19 convalescent plasma treatment include allergic reactions, transfusion-associated circulatory overload and transfusion-associated lung injury, as well as the potential for transfusion-transmitted infections.
Read the FDA’s full news release here.
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