FDA, under pressure, to authorize blood plasma as Covid-19 treatment
WASHINGTON — President Trump is expected to announce Sunday evening that the Food and Drug Administration will authorize the use of blood plasma from patients who have recovered from Covid-19 as a treatment for the disease, according to an individual familiar with the plans.
The decision, which 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.
Blood 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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A study conducted by the Mayo Clinic and the National Institutes of Health found 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 later. That study, while large, did not include a placebo group, making it difficult to interpret the data.
It was not immediately clear whether Trump or other U.S. health officials, including FDA Commissioner Stephen Hahn or Health and Human Services Secretary Alex Azar, would be releasing new data at a news conference planned for Sunday evening.
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The move comes less than a week after officials at the National Institutes of Health staged a rare intervention to stop the FDA from issuing what is known as an “emergency use authorization” for blood plasma to treat Covid-19. 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 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.
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 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.
Adam Feuerstein contributed reporting.
