FDA Gives Emergency OK To Convalescent Plasma As COVID Treatment

The Washington Post: Trump Touts FDA’s Emergency Authorization Of Convalescent Plasma As Historic Breakthrough, But Scientists Are Doubtful 
President Trump announced Sunday that he had helped break through a regulatory “logjam” to grant emergency authorization of convalescent plasma to treat covid-19, a “powerful therapy” that he claimed “had an incredible rate of success,” despite the fact that his own scientists are calling for more studies to definitively show it works. The announcement, at a news conference where Trump was flanked by Food and Drug Administration commissioner Stephen Hahn and Health and Human Services Secretary Alex Azar, drew criticism from physicians and scientists, who said their statements misled the public by overstating the evidence behind a therapy that shows promise but still needs to be rigorously tested. (Johnson, McGinley, Dawsey and Min Kim, 8/23)

AP: Trump Announces Plasma Treatment Authorized For COVID-19
In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, said: “COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months.” But Trump had made clear to aides that he was eager to showcase good news in the battle against the virus, and the timing allowed him to head into his convention with momentum. He and aides billed it as a “major” development and used the White House briefing room to make the announcement. (Lemire and Stobbe, 8/24)

Politico: FDA Authorizes Plasma Treatment Despite Scientists' Objections
Trump in a brief Sunday evening news conference appeared to oversell the FDA's assessment, claiming the agency found plasma "safe and very effective." The agency itself said more rigorous study is needed to prove whether the treatment effective. Janet Woodcock, the head of FDA's drug division who is now working on Operation Warp Speed, an interagency effort to accelerate coronavirus treatments and vaccines, on Friday told POLITICO that plasma has not been "proven as an effective treatment." Trump also returned to his recent accusations that government scientists were holding up potential coronavirus treatments for political reasons. "We broke the logjam over the last week," he said. "I think there are people in the FDA and actually in [the larger health] department that can see things being held up." (Brennan and Owermohle, 8/23)

NPR: FDA Authorizes Convalescent Plasma As Emergency Treatment For COVID-19 
Joined by Health and Human Services Secretary Alex Azar and FDA Commissioner Stephen Hahn for what he called a "truly historic" announcement, President Trump described the treatment as safe and effective. Convalescent plasma, Hahn explained, is the liquid portion of the blood that contains the antibodies an individual develops in response to an infection and can be given to patients currently fighting that virus. He said this treatment has long been a part of the infectious disease arsenal. (Treisman, 8/23)

CNN: US FDA Announces Emergency Authorization For Convalescent Plasma To Treat Covid-19
Last week, Trump accused some health officials of playing politics regarding an EUA for convalescent plasma. When asked about the FDA not having granted an EUA, Trump said the reason was political. (Gupta, Gumbrecht and Fox, 8/23)

The Wall Street Journal: FDA Authorizes Convalescent Plasma For Covid-19 Use 
The FDA said more clinical studies are necessary for definitive proof of the therapy’s effectiveness. (Burton and Dockser Marcus, 8/23)

Stat: Is Convalescent Plasma Safe And Effective? 
The Mayo Clinic study showed that patients who received transfusions within three days of their Covid-19 diagnosis had a seven-day death rate of 8.7%, while patients who received plasma treatment after four or more days had a mortality rate of 11.9% (Facher, 8/23)