President Donald Trump announced late on Sunday that the FDA has issued an “emergency use authorization” for convalescent plasma as a potential treatment for the coronavirus.
“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,” Trump said. “It’s had an incredible rate of success. Today’s action will dramatically expand access to this treatment.”
“This is the only possible – and it’s only made possible because of Operation Warp Speed that has everybody working together,” Trump added. “We’re years ahead of approvals. We would be – if we went by the speed levels of past administration, we’d be two years, three years behind where we are today, and that includes in vaccines that you’ll be hearing about very soon, very shortly.”
BREAKING: U.S. FDA issues emergency use authorization for convalescent plasma as potential treatment for COVID-19, President Trump announces. pic.twitter.com/8xneaZW8m7
— NBC News (@NBCNews) August 23, 2020
The FDA “issued an emergency use authorization (EUA) 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 agency said in a statement. “Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, 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.”
HHS Secretary Alex Azar said that “America has done more than any other country to expand the arsenal that we have to battle COVID-19.”
“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 percent better survival in the patients who benefited most from the treatment — which were patients under 80 who were not on artificial respiration.”
“I just want to emphasize this point because I don’t want you to gloss over this — this number,” Azar added. “We dream, in drug development, of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance.”
FDA Commissioner Dr. Stephen M. Hahn said that “a 35 percent improvement in survival” is “a pretty substantial clinical benefit.”
“What that means is — and if the data continue to pan out — 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma,” Hahn added. “We’ve seen a great deal of demand for this from doctors around the country.”
"A 35 percent improvement in survival is a pretty substantial clinical benefit," FDA Commissioner @SteveFDA said in relation to the convalescent plasma emergency use authorization issued today. pic.twitter.com/Dd97vLSZeL
— U.S. FDA (@US_FDA) August 23, 2020
This report has been updated to include additional information.