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Trump announces emergency FDA authorization for new plasma COVID-19 treatment

President Donald J. Trump addresses his remarks during the coronavirus update briefing Wednesday, April 8, 2020, in the James S. Brady Press Briefing Room of the White House. (Official White House Photo by D. Myles Cullen)
August 23, 2020

President Donald Trump on Sunday announced the U.S. Food and Drug Administration’s (FDA) decision to grant an emergency use authorization to use convalescent plasma for treating coronavirus patients.

Trump announced the approval of convalescent plasma at a White House press briefing. He said the treatment can reduce mortality rates in COVID-19 patients by up to 35 percent.

The convalescent plasma treatment method uses the blood plasma of patients who have been diagnosed with and recovered from COVID-19 to treat patients currently suffering from the illness.

Trump said, “this is a powerful therapy, that transfuses very very strong antibodies from the blood of recovered [coronavirus] patients to help patients battling a current infection. It’s had an incredible rate of success. Today’s action will dramatically expand access to this treatment.”

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Trump said the approval to use convalescent plasma was made possible through his administration’s efforts to find coronavirus treatments, known as “Operation Warp Speed.” Trump said “we’re years ahead of the approvals” and “if we went by the speed levels of past administrations, we would be two years, three years behind where we are today, and that includes a vaccine you will be hearing about very shortly.”

The decision to approve convalescent plasma for emergency use comes after the federal government funded a $48 million study at the Mayo Clinic, which tested the efficacy of the treatment. Trump said, and he said the treatment method has shown to have reduced mortality rates by 35 percent among patients.

Speaking at the press briefing, U.S. Secretary of Health and Human Services Alex Azar said “we dream in drug development of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients.”

Azar said the highest efficacy cases for the convalescent plasma treatment come among patients who seek the treatment within three days of their diagnosis. Azar said the patients who benefitted most were under 80-years-old, who were not using means of artificial respiration.

Azar also announced Americans who have tested positive with and recovered from COVID-19 can visit coronavirus.gov to find out how to donate their plasma.

“Know, if you donate plasma, you could save a life,” Azar said.

The call to “Donate Plasma” was flashed on screens throughout Trump’s press briefing Sunday.

The Department of Defense also announced in May an initiative to collect 8,000 units of convalescent plasma by Sept. 30 and has since expanded that goal to 10,000 units.

FDA commissioner Stephen Hahn said the FDA has been working since April to study convalescent plasma as a possible treatment option. Hahn said the FDA reviewed data from the convalescent plasma use in an expanded access program as well as more than a dozen published studies on the subject and determined said FDA scientists had concluded “that COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization.”

Hahn said the FDA would continue to collect data on convalescent plasma.

Scientists are also working to fast-track the development of a coronavirus vaccine under “Operation Warpspeed” and Trump has