The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for convalescent plasma as a treatment for COVID-19 among hospitalized patients this week, determining that its known and potential benefits outweigh any risks.
Convalescent plasma is made using the blood of those who have recovered from SARS-CoV-2 infections. For those issued plasma, side effects can include allergic reactions, circulatory overload, lung injury, or transfusion-transmitted infections. However, more than 70,000 patients have been treated with convalescent plasma, according to a statement from Health and Human Services Secretary Alex Azar.
By the FDA’s estimation, treatment via plasma resulted in a 37 percent reduction in mortality at seven days.
“Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials,” Azar said. “We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma.”
The FDA has reviewed data from efforts to facilitate emergency access to convalescent plasma for several months. Clinical trials to demonstrate safety and efficacy through clinical trials remain ongoing. With the EUA declaration, convalescent plasma can now be utilized by healthcare providers to treat suspected or lab-confirmed COVID-19 cases in hospitalized patients, specifically. No adequate, approved or available alternative treatments exist, the FDA noted, and the EUA will not replace or end randomized clinical trials.
“We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” FDA Commissioner Stephen Hahn said. “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.”