FDA issues emergency use authorization for convalescent plasma as potential COVID–19 treatment

The U.S. Food and Drug Administration issued an emergency use authorization Sunday for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19.

The antibody-rich blood component is taken from patients who have recovered from COVID-19, and Sunday’s action permits use of the treatment on hospitalized COVID-19 patients within three days of diagnosis.

According to The Wall Street Journal, studies and clinical trials continue, but the step opens up the possibility for quicker, easier access to the treatment.

In a Sunday news conference, U.S. President Donald Trump cited the program’s “incredible rate of success” in announcing the FDA’s step for which he credited the removal of “unnecessary barriers and delays, not by cutting corners, but by marshalling the full power of the federal government.”

FDA Commissioner Stephen M. Hahn said during Trump’s Sunday news conference that the medical community is, of course, “waiting for more data,” but called the success rate for the use of convalescent plasma a “pretty substantial clinical benefit.”

Specifically, Health and Human Services Secretary Alex Azar said the data collected to date indicates that patients over the age of 80 and not using artificial respiration who have used the treatment within three days of diagnosis saw a 35% mortality reduction.

“We dream in drug development of something like a 35% mortality reduction,” Azar said.

He also said that 70,000 American patients have already benefited from the treatment to date.

Specifically, the FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in those hospitalized patients identified as best candidates. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that there are no adequate, approved, and available alternative treatments, the agency said in a news release.

Cox Media Group