FDA Authorizes ‘Convalescent Plasma’ as a Treatment for COVID-19

At a White House briefing on Sunday, President Donald Trump announced the U.S. Food and Drug Administration’s (FDA) emergency authorization for “convalescent plasma” in the battle against COVID-19.

“On the therapeutics front, this is what I’ve been looking to do for a long time,” the president said. “This is a great thing. Today, I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives. The FDA has issued an emergency use authorization — and that’s such a powerful term: emergency use authorization — for a treatment known as convalescent plasma. This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection. It’s had an incredible rate of success.

“Today’s action will dramatically expand access to this treatment. And I want to thank Dr. Hahn and Secretary Azar. I want to thank the FDA — all of the people that have been working very hard on this.  It showed tremendous potential.”

Secretary Alex Azar of the Department of Health and Human Services spoke at the briefing about this particular treatment’s success thus far.

“The data we gathered suggests that patients who were treated early in their disease course — within three days of being diagnosed — with plasma containing high levels of antibodies benefited the most from treatment,” Azar said. “We saw about a 35% better survival in the patients who benefited most from the treatment — which were patients under 80 who were not on artificial respiration.”

That 35% number is impressive, according to Azar.

“I just want to emphasize this point because I don’t want you to gloss over this — this number. We dream, in drug development, of something like a 35% mortality reduction. This is a major advance in the treatment of patients. This is a major advance,” he said.

Dr. Stephen Hahn, the commissioner of the FDA, explained how convalescent plasma works.

“So, plasma is the liquid portion of the blood.  That liquid portion contains the natural immunity that someone develops in response to an infection — in this case, COVID-19 — and that liquid portion can be extracted. And for many years, as the President and Secretary Azar said, it’s been given to patients with infectious diseases — for more than 100 years. So, there was a really good rationale for why this might work.”

COVID-19 survivors can donate their blood, which contains the antibodies within their plasma that will fight the disease. That plasma is then injected into current patients in the early stages of the disease. According to Dr. Hahn, over 70,000 Americans have received the treatment in a Mayo Clinic project supported by the federal government.

That Mayo Clinic study, together with a dozen other published studies on convalescent plasma, allowed the FDA, according to Dr. Hahn, to conclude that “COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization.”

Azar and Hahn emphasized that the ongoing results of convalescent plasma will continue to be studied. And this treatment is not the only one under review.

“Convalescent plasma is one new tool that we’ve added to our arsenal against COVID-19, alongside Remdesivir, steroids, and a number of other promising options currently being studied,” Secretary Azar said.  “Because of the president’s Operation Warp Speed, we expect to have other new results and new options reaching patients as soon as this fall.”

Photo from Shutterstock

 

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