Food and Drug Administration Commissioner Stephen Hahn apologized for overstating benefits of using convalescent plasma to treat COVID-19 patients.
Earlier this week, while issuing emergency use authorization or EUA for investigational convalescent plasma to treat COVID-19 in hospitalized patients, the FDA had said that the EUA decision was based on scientific data from the preliminary findings of Mayo Clinic observations. It was also stated that out of 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.
President Donald Trump, in his press briefing to announce the EUA news, on the eve of his Republican National Convention, also called the decision a historic breakthrough.
However, Hahn later tweeted an apology, saying “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”
The blood from those people who have recovered from the disease is called convalescent plasma. Plasma is the liquid portion of the blood. After viral infection, one’s plasma contains antibodies that can be used to fight infection.
The FDA had stated that in early April, an expanded-access program was started at the Mayo Clinic, which has now gone on for the last four months, with the support of the federal government, under President Trump’s leadership.
More than 90,000, close to 100,000 Americans have enrolled in the program and over 70,000 have received the potential promising treatment.
Hahn stated then that FDA scientists have concluded that COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an EUA. The agency also noted that the known and potential benefits of the product outweigh the known and potential risks of the product.
However, the FDA’s decision to issue EUA to a treatment which is yet to be proved scientifically had faced significant criticism, with many of them calling it a politically motivated decision.
Multiple reports stated that the proper results of the treatment are yet to be known.
According to the World Health Organization’s chief scientist Dr. Soumya Swaminathan, using plasma from the recovered to treat COVID-19 is still considered an experimental therapy, and that the preliminary results are still inconclusive.
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