The US Food and Drug Administration on Sunday issued an emergency use authorization for convalescent plasma to treat Covid-19, saying the “known and potential benefits of the product outweigh the known and potential risks of the product.”
The FDA said more than 70,000 patients had been treated with convalescent plasma,which is made using the blood of people who have recovered from coronavirus infections.
“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, referring to the coronavirus that causes Covid-19. “Today’s action will dramatically increase access to this treatment.”
Last week, Trump accused some health officials of playing politics regarding an EUA for convalescent plasma. When asked about the FDA not having granted an EUA, Trump said the reason was political.
On Sunday, a source who is close to the White House Coronavirus Task Force told CNN the FDA had reviewed additional data to inform its EUA decision. This official has not personally reviewed the data. They added the FDA is under no obligation to consult anyone outside the agency about its decision.
Convalescent plasma is taken from the blood of people who have recovered from Covid-19. At the end of March, the FDA set up a pathway for scientists to try convalescent plasma with patients and study its impact. It has already been used to treat more than 60,000 Covid-19 patients.
However, like blood, convalescent plasma is in limited supply and must come from donors. And while there are promising signals from some studies, there is not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.