WASHINGTON — The Food and Drug Administration announced Sunday that it has authorized the use of blood plasma from patients who have recovered from Covid-19 as a treatment for the disease.

The decision to issue an emergency use authorization, which President Trump’s press secretary heralded ahead of time as a “major therapeutic breakthrough,” likely falls far short of that description — and could generate intense controversy inside the administration and the broader scientific community.

So-called convalescent plasma is among a host of potential therapeutics that have been undergoing testing in clinical trials. The hope is that infusions of antibody-rich plasma from those who have recovered from Covid-19 can be injected into ill patients, kickstarting their immune system and allowing them to fight off the virus until they can generate their own antibodies.

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“Today’s action will dramatically expand access to this treatment,” Trump said at a White House news conference Sunday afternoon. He called the EUA a “truly historic announcement” and said that convalescent plasma has been proven to reduce mortality by 35%, which he called a “tremendous number.”

Alex Azar, secretary of Health and Human Services, followed Trump. “We dream in drug development of something like a 35% mortality reduction,” he said. “This is a major advance in the treatment of patients.”

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An FDA staffer who reviewed the data on convalescent plasma — and whose name was redacted from a memo released by the agency — was far less enthusiastic, writing that the data “support the conclusion that [convalescent plasma] to treat hospitalized patients with COVID-19 meets the ‘may be effective’ criteria for issuance of an EUA. Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of … efficacy and to determine the optimal product attributes and the appropriate patient populations for its use.”

The announcement comes less than a week after officials at the National Institutes of Health staged a rare intervention to stop the FDA from issuing the emergency use authorization. NIH officials involved in the decision told the New York Times that more data, derived from randomized controlled trials, were needed.  

The announcement also follows sustained pressure from the president on his own administration. Trump told reporters last week that U.S. officials were slow-walking clearance of blood plasma until after the November election. He also took to Twitter on Saturday to criticize the FDA for making it difficult to test vaccines and therapeutics, though he didn’t specifically mention plasma.

Trump thanked FDA Commissioner Stephen Hahn, who participated in the news conference, for issuing the EUA, adding, “The FDA really stepped up, and especially over the last few days in getting this done.”

Asked by a reporter about the hold up in issuing the EUA, Trump said, “There are people in the FDA and actually in your larger department [HHS] that can see things being held up and wouldn’t mind so much — its my opinion, a very strong opinion — and that’s for political reasons.”

He added, “We are being very strong and we are being very forthright, and we have some incredible answers, and we’re not going to be held up.”

The documents released by the FDA do not make clear where the 35% figure cited by Trump and Azar comes from. But it may be based on a study conducted by the Mayo Clinic and the NIH, which indicated that plasma treatments appeared to have a small but statistically significant impact on reducing mortality in hospitalized Covid-19 patients who received the infusions within three days of the onset of symptoms, compared with those who got plasma after four days or later.

The death rate after seven days was 8.7% in patients treated early and 11.9% in those not treated until later. But that study, while it included more than 35,000 patients, did not include a placebo group and was not randomized, making it difficult to interpret the data. And it hasn’t been peer-reviewed by other scientists and published in a medical journal.

The EUA drew quick reaction from health experts. Eric Topol, founder and director of the Scripps Research Translational Institute, tweeted that it was “outrageous” to claim a 35% improved survival from that study. “There’s no evidence to support any survival benefit. 2 days ago FDA’s website stated there was no evidence for an EUA,” he wrote. And Rachel Sachs, an associate professor of law at Washington University in St. Louis, wrote that given the political pressure on the FDA, issuing the EUA without publishing the evidence and without a supporting randomized trial “risks further damage to public trust in the agency.” 

But former FDA commissioner Scott Gottlieb tweeted, “Plasma is probably incrementally helpful to Covid patients and meets criteria for an EUA.” He added, “We need to keep FDA decisions with FDA. The FDA professional staff supported this. It’s their decision.”

Trump has personally touted the purported benefit of plasma. He has called it a “beautiful ingredient” and his administration also announced last month the launch of an $8 million dollar advertising campaign, including billboards and radio ads, to encourage Americans who have recovered from Covid-19 to donate plasma. 

It’s unclear whether the EUA will result in a meaningful expansion in access to the convalescent plasma therapy, as the president claimed. Tens of thousands of Covid-19 patients have already received the treatment through the FDA’s expanded access program, and the supply is limited by the number of recovered patients who donate plasma.

An emergency use authorization is not the same as a full approval in FDA parlance. The agency issues EUAs when it “is reasonable to believe that the product may be effective” and “the known and potential benefits outweigh the known and potential risks.” 

The FDA said the EUA “is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma.”

The agency has issued dozens of EUAs during the course of the coronavirus pandemic — mostly for diagnostic tests but also for some drugs — but at times has been forced to reverse course. The FDA, for example, revoked an EUA for the malaria drug hydroxychloroquine, which was personally touted by Trump as a treatment for Covid-19 but found in studies to be ineffective and possibly harmful.

This story has been updated with the FDA announcement and comments from the White House news conference. Adam Feuerstein contributed reporting. 

  • Why ask for placebo? Placebo can really be unethical when you consider the shocking 88% mortality in NYC for patients on ventilators. Not everything Trump does is silly. Plasma helps. That’s fine. STAT is usually great journalism. This article is not scientifically serious enough. Plasma has been studied for two months now….@ certainly better than the antivirals which seem useless.

  • can you add: what was number observed and per subsets, e.g., number under 80 and less than or 3 days symptoms vs number under 80 and symptoms four plus days vs. number over 80. then, what was percent deaths per subset. …. even though not a control group, maybe same age distribution from location without plasma…and mean number of deaths for those without tx…. I’m other words more data on same track you are doing. thanks!!!

  • OMG, this is worse than the first crap TRump pushed. How can they possible say take it if you are going to die anyways, if the study says it is “most effective” when administered with the first 3 days of symptoms. This is DANGEROUS AND FOOLISH!

    • This article links to a press release from Mayo clinic indicating over a 25% decrease in death rate in a study (but not double blind apparently) of 5,000 patients.
      That is a lot of patients – they may really be on to something – I understand Trump does not understand science and is acting politically, but the FDA is famous, really, really, really famous, for excessively conservative restrictions on medicine. They will point to the thalidomide and DES disasters as the advantages of their approach, but the critics have so many stories of ongoing disasters because drugs were forbidden here – and despite the ultra conservative nature of FDA, drugs with plenty of users, which FDA likely would never allow to be sold, but already are, over the country – probably acetaminophen for example – maybe aspirin, too – are not only being sold still, but sold with rather weak warnings of dangers. Suggesting political considerations are already influencing the agency.

  • What really bothers me is that there were 70,000 patients given Convalescent Plasma and the biggest clinical trials is 600 patients and after 4 months, it is still not done. I am bothered by the lack of leadership here. There should have been a 40 institution trial, enrolling 1,500 and it should have been done by now. (Granted, early on there were not that many people to harvest convalescent plasma. There sure are plenty now.). How is it that the NIH is not showing any leadership here? Are they not able to coordinate studies? Outside of the 600 patient study that I mentioned above, there are about 5 other us RCT with a goal of 50 enrollees. Just 50???!!

  • JK

    I agree leronlimab is the key. The science is definitely there. It’s just a matter of time. We all need to be patient while cytodyn
    goes through all obstacles that the FDA throw at them. And we can all relax and not worry about getting the chinese virus.

  • a family member is in medicine, and this is a breakthrough. Quit making this about Trump or Biden….

  • Once again, IQ puts his political survival against science–because he knows that his ship is sinking. Just one more action in the Grasping At Straws (GAS) campaign.

  • a close friend of mine was on ventilator for 3 months received 2 transfusions of plasma in his treatment walked out of hospital and now swimming with his grandson.

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