FDA issues an Emergency Use Authorization (EUA) for Convalescent Plasma to treat COVID-19
The US Food and Drug Administration issued an emergency use authorization for the use of convalescent plasma to treat Covid-19 on Sunday, saying the "known and potential benefits of the product outweigh the known and potential risks of the product."
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The FDA said more than 70,000 patients had been treated convalescent plasma, made using the blood of people who have recovered from coronavirus infections.
Treating COVID-19 With The Use Of Convalescent Plasma
- There is significant anecdotal data on the value of convalescent plasma in the treatment of COVID-19. This is another example of how we are succeeding in saving the lives of those most at risk of dying from COVID-19.
- 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.
- 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.
- 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.”
- Eli Lilly and Regeneron are developing COVID treatments based on the antibodies found in convalescent plasma.
Former FDA Associate Commissioner
President of the Center for Medicine in the Public Interest
Visiting Professor at the University of Paris School of Medicine