FDA Has Second Ideas on Convalescent Plasma for COVID-19

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FDA Has Second Thoughts on Convalescent Plasma for COVID-19

On Sunday, the Food and Drug Administration approved an Emergency Use Authorization (EUA) for convalescent plasma for the treatment of COVID-19. "The known and potential benefits of the product outweigh the known and potential risks of the product," the FDA said in a press release.

Speaking of the emergency during a press conference on Sunday, President Donald Trump said, "This is what I've been looking for. This is a great thing." He said such approval would expand access to "powerful therapy".

Margaret Hamburg was less convinced. “We know that convalescent plasma has been used to treat patients for decades. What we don't know is how it works in this case. Is It Really Effective? "she said in comments to NPR. Hamburg, a former FDA commissioner, stressed the importance of proper testing to determine how best to use plasma." In my view, there is now an urgent need to really get the right study done with it we can ask and answer the questions. Does it really work for whom and when in the course of the disease? With this information we can really best help patients, "she said.

Just a few days earlier, the FDA had stopped using blood plasma as a COVID-19 treatment, largely because the treatment had not been properly reviewed under clinical trial controls. But President Trump wasn't pleased.

Dr. Hamburg was not the only scientist who was skeptical of her previous employer's move. In a report from the UK, the World Health Organization said the use of blood plasma to treat COVID-19 patients is still experimental. The results that are there, WHO chief scientist Soumya Swaminathan, MD, said at a press conference, "is still very inferior evidence." The treatment is difficult to standardize because not everyone produces the same amounts of antibodies.

Human blood has many parts. Strain out the larger pieces and what remains is a rich liquid called plasma. Scientists believe that the life-saving COVID-19 antibodies are in the plasma. After an illness, the body retains a memory of the illness in order to fight it again. These memories are the antibodies. The theory is to take antibodies from former patients and give them to current patients.

Emergency clearance allows the FDA to judge a drug or treatment based on the evidence already available, rather than performing more rigorous testing like the vaccine studies do. The Mayo Clinic, which is conducting a study, reports side effects of plasma therapy as "allergic reactions, lung damage and breathing difficulties, and the transmission of infections, including HIV and hepatitis B and C.

As of August 24, the Mayo Clinic has admitted 103,126 patients and performed 72,461 infusions.

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