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.
“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.”
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.