President Trump: FDA Provided an Emergency Use Authorization for a Highly Successful Coronavirus Treatment

Posted: Aug 23, 2020 5:57 PM
President Trump: FDA Provided an Emergency Use Authorization for a Highly Successful Coronavirus Treatment

Source: AP Photo/Alex Brandon

President Donald Trump on Sunday announced that the Federal Drugs Administration (FDA) has approved an Emergency Use Authorization (EUA) for convalescent plasma to be used as a treatment for the Wuhan coronavirus. 

"Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives," President Trump said at a White House briefing on Sunday. "Today's action will dramatically increase access to this treatment."

Through this treatment, those who have successfully recovered from the virus donate antibodies. Those who are currently sick with the Wuhan coronavirus will receive the antibodies, which helps their body fight the virus.

From the FDA's FAQ about the treatment:

Convalescent refers to anyone recovering from a disease. Plasma is the yellow, liquid part of blood that contains antibodies. Antibodies are proteins made by the body in response to infections. Convalescent plasma from patients who have already recovered from coronavirus disease 2019 (COVID-19) may contain antibodies against COVID-19. Giving this convalescent plasma to hospitalized people currently fighting COVID-19 may help them recover. FDA has issued an emergency use authorization for convalescent plasma to be used in hospitalized COVID-19 patients and is being investigated for the treatment of COVID-19 because there is no approved treatment for this disease. Based on scientific evidence available, the FDA concluded this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product in hospitalized COVID-19 patients.

According to the president, the Mayo Clinic received $48 million to test the efficacy of the treatment. It was discovered that the mortality rate is cut by 35 percent, which is considered a significant reduction. As of now more than 100,000 Americans are currently enrolled to receive treatment. 

The federal government has also provided $237 million so the Red Cross can collect up to 350,000 units of plasma for those fighting the Wuhan coronavirus.

"This treatment has been tried and trued in past pandemics," Health and Human Services Secretary Alex Azar said. The treatment appears to be most effective for those under 80 who receive plasma within the first three days of being diagnosed. 

"This is a major advance in the treatment of a patient, a major advance," Azar emphasized. 

FDA Commissioner Stephen Hahn said that the EUA allows physicians to continue to meet demands across the nation. The FDA plans to continue to gather data on the success of convalescent plasma, although the data they have currently collected shows the benefits outweigh costs. Hahn pointed to the 35 percent survival rate as evidence of that.