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# FDA Allows Controversial Convalescent Plasma for Covid
- URL: https://www.fdaweb.com/fda-allows-controversial-convalescent-plasma-for-covid/
- Published: 2020-08-24T12:00:00.000Z
- Updated: 2026-09-14T16:26:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147494

Amid a swirl of Trumpian controversy, FDA 8/23 issued an emergency use authorization (EUA) for Covid-19 convalescent plasma (CCP) and its use in treating hospitalized Covid-19 patients. Many FDA watchers are calling out FDA commissioner **Stephen Hahn** for misleadingly stating that 35% of those treated with plasma would be saved. Scripps Research Translational Institute director **Eric Topol** said that the observational data the agency relied on indicates that three people would be saved at seven days, or five at 30 days. “And that was via exploratory analyses,” he said in a Twitter post. “Not only blatantly wrong; an egregious public statement,” Topol said. And *The Hill* quoted **Paul Offit**, director of the Vaccine Education Center at Children’s Hospital of Philadelphia as saying “The FDA was once again bullied into doing something that it initially wasn’t going to do.”  

[The EUA](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=082320%5FPR%5FIssues%20EUA%20for%20Convalescent%20Plasm&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=15095&elqTrackId=699414B0A6B3CD846B1F65D6BC78AE7D&elq=7d0aa62cef1c421a82f30b749a03a74a&elqaid=13931&elqat=1) says that “current data suggest the largest clinical benefit is associated with high-titer units of CCP administered early in the course of disease. Adequate and well-controlled randomized trials remain necessary for a definitive demonstration of CCP efficacy and to determine the optimal product attributes and appropriate patient populations for its use.”  
  
The emergency authorization comes on the heels of controversial pressure from president Trump, whose recent Tweets and statements have criticized FDA and alleged “deep state” employees were delaying the approval process for therapeutics and vaccines related to the Covid-19 pandemic to hurt the president’s reelection bid. Last week, FDA had temporarily put the brakes on the plasma therapy EUA until more data are presented to demonstrate its effectiveness ([see story](https://www.fdaweb.com/blood-plasma-emergency-use-authorization-stalls/)). NIH director **Francis Collins** and National Institute of Allergy and Infectious Diseases director **Anthony Fauci** reportedly intervened in the EUA review, arguing the data were not robust enough to support such a move.  
  
During an 8/19 White House press conference, Trump was asked to comment on FDA’s plasma delay. “And it could be a political decision, because you have a lot of people over there that don’t want to rush things because they want to — they want to do it after November 3rd,” Trump [responded](https://www.whitehouse.gov/briefings-statements/remarks-president-trump-press-briefing-august-19-2020/?ref=fdaweb.com). “But I’ve heard fantastic things about convalescent plasma. And I’ve heard numbers way over 50% success. And people are dying, and we should have it approved if it’s good. And I’m hearing it’s good. I heard from people at the FDA that it’s good. So we’ll see. I’m going to check that right after this conference.”  
  
At an 8/23 [news conference](https://www.whitehouse.gov/briefings-statements/remarks-president-trump-press-briefing-august-23-2020/?ref=fdaweb.com), Trump called the convalescent plasma EUA an “historic announcement,” but he also lowered its efficacy from over 50% success to “proven to reduce mortality by 35%.” HHS secretary **Alex Azar** said at the news conference that patients who benefited most from treatment were those “under 80 who were not on artificial respiration.”  
  
FDA commissioner **Stephen Hahn** told reporters that under a Mayo Clinic expanded access clinical trial over 70,000 patients have received CCP treatment. “So, in the independent judgment of experts and expert scientists at FDA who have reviewed the totality of data — not just the data from this expanded-access program, but more than a dozen published studies, as well as the historical experience associated with this — those scientists have concluded that Covid-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization,” Hahn said.  
  
Hahn did note that FDA is still waiting for more data. “We’re going to continue to gather data,” he said. “But this clearly meets the criteria that we’ve established for emergency use authorization, and we’re very pleased with these results.”  
  
Meanwhile, health advocacy group Public Citizen reacted to the EUA by calling it a worrisome political decision by FDA. Referencing NIH’s interference and call for more data last week, Public Citizen had this to say: “Make no mistake – The FDA’s decision to grant an emergency use authorization for Covid-19 convalescent plasma on the eve of the Republican National Convention represents the most blatant politicization of FDA decision making in history. Such action seriously damages the FDA’s credibility during the greatest public health crisis in 100 years. This does not bode well for future FDA decisions regarding Covid-19 vaccines and therapeutics between now and election day.”