Transcript for FDA authorizes emergency convalescent plasma use for COVID-19 patients
Good to be here today to announce FDA's recent decision. From the beginning of this pandemic the president has asked FDA. To cut back red tape to try to speed medical products in the hands of providers patients and American consumers. And I just wanna pick of the president's thanks to more than 171000. Men and women who work at FDA they've worked Dane Knight to in fact do that. Oh plasma is even liquid portion of the blood. That liquid portion can teams in natural immunity that someone develops in response to infection in this case Covert nineteen. And and that liquid portion can be extracted and for many years as the president and secretary ace are said. And given to patients with infectious diseases for more than a hundred years so there was a really good rationale for why this might work. And in fact as was mentioned. In early April and being expanded access program it started at the Mayo Clinic with the support of the federal government. I'm not present trumps leadership. And that has gone on for the last four months more then a 90000 post a 100000 Americans have enrolled in this program. And over 70000 have received treatment this is one of the largest expanded access programs. In the history of FDA so very successful. Approach to evaluating how accomplice of plasma. Would work. So in the independent judgment and experts and experts scientists and FDA. Who have reviewed the totality of data not just the data from this expanded access program. But more than that a dozen published studies as well as the historical experience associated with this. Those can those scientists have concluded that cove in nineteen convalescent plasma is safe. Which is promising efficacy. Thereby meeting the criteria for emergency use authorization. In the optimal treatment at the optimal patience as described by secretary a's are treated with convalescent plasma at highest tigers. There was a 35%. Improvement in survival. Which is a significant clinical benefit. Now we're waiting for more data. Really continue to gather data. But this clearly meets the criteria that we've established for emergency use authorization. And we're very pleased with these results so let me just put this in perspective many you know it's a cancer doctor before I. I'm became FDA commissioner and a 35% improvement in survival is a pretty substantial clinical benefit what that means is it and in the data continue to pan out. A hundred people who are sick. Let's go in 1935. Would have been saved because of the administration classmen we seen a great deal of demand for this from doctors around the country. On and what this EU aid does the UAU emergency use authorization today does it allows us to continue that. You meet the demand. And again I want to echo the president's in the secretary's. Asking the American people if you've recovered from October 19 please donate it could save a life.
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