CoronavirusFDA OKs Use of Convalescent Plasma for COVID-19

By Stephanie Soucheray

Published 25 August 2020

On Sunday, the Food and Drug Administration (FDA) announced it has approved plasma from recovered COVID-19 patients to be used as a hospital-based treatment for the novel coronavirus under an emergency use authorization (EUA). In a White House press conference, President Trump and FDA director Stephen Hahn both claimed that treatment with convalescent plasma “reduced mortality in hospitalized patients by 35%,” but the FDA’s own press release was much more circumspect. Many scientists pointed out that the Mayo Clinic study cited by both Trump and Hahn clearly stated that 3.2 people out of 100—not 35—would be saved by the administration of convalescent plasma, and that even to achieve this result, the plasma must be administered within three days of infection. Still, even without the hype, and subject to additional controlled, randomized clinical trials, scientists say, this is welcome news.

Editor’s note: On Monday (24 August) afternoon, FDA director Stephen Hahn apologized for publicly agreeing with Trump’s false and misleading characterization of the Mayo Clinic study about convalescent plasma as a treatment for COVID-19 patients. Hahn stood next to Trump in a Sunday evening press conference in which Trump, who spoke first, falsely claimed that the study shows that using the plasma treatment would save 35 lives out of every 100 people who get the treatment (the actual number, cleaerly stated in the study, is a tenth of that: the lives of 3.2 patients out of a 100 would be saved). Hahn’s support of Trump’s false claim has brought withering criticism from scientists who argue that not only was it a gross and fatuous exaggeration of the benefits of plasma treatment based on a non-randomized study with no placebo group, but that by publicly agreeing with the president’s falshood Hahn was undercutting the FDA’s claim that it was basing its emergency authorization of the plasma treatment on science, not on the president’s re-election calculations. “I can’t remember a mistake by FDA or the commissioner as serious as this one,” Dr. Eric Topol of the Scripps Translational Research Institute tells NPR. On Monday evening, Hahn tweeted an apology, saying “The criticism is entirely justified.”

__________

On Sunday, the Food and Drug Administration (FDA) announced it has approved plasma from recovered COVID-19 patients to be used as a hospital-based treatment for the novel coronavirus under an emergency use authorization (EUA).

The move was announced during an unscheduled press conference by President Donald Trump Sunday evening, just a day before the Republican National Convention begins. Critics said Trump portrayed the EUA as a treatment breakthrough to boost support as the 3 November presidential election draws nearer.

Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective,” Trump said. He also said, citing a non–peer-reviewed Mayo Clinic study, that the treatment reduced mortality in hospitalized patients by 35%.

Stephen Hahn, MD, the head of the FDA appeared alongside Trump and also spoke of the 35% reduction in mortality.