President Donald Trump said a coronavirus treatment that involves blood plasma donated by people who’ve recovered from COVID-19 will be expanded to more sick Americans, widening access to a promising therapy even before researchers fully understand how well it works.
“This is a powerful therapy,” Trump said at a White House news conference. “Today’s action will dramatically expand access to this treatment.”
The U.S. Food and Drug Administration confirmed Sunday that it had cleared what’s known as convalescent plasma for use in certain patients. The move would make it easier to receive the treatment, which Trump has promoted even though studies to prove its benefits haven’t been completed. Bloomberg News reported earlier that the announcement was forthcoming.
Trump, who on Saturday had accused regulators of moving slowly to attempt to diminish his chances of re-election, said the FDA had concluded the therapy is “safe” and “very effective.” It has yet to undergo the full set of clinical trials usually required of drugs seeking approval by the agency.
Top Trump administration officials said that even without a completed clinical trial, the case for allowing more people to receive convalescent plasma was strong, and urged Americans who had been sick to donate plasma. Infusing patients with antibodies collected from others has been used to treat infections in previous viral epidemics for roughly a century.
“Convalescent plasma has been a tried-and-true therapeutic treatment in prior outbreaks,” Health and Human Services Secretary Alex Azar said at the news conference.
Additionally, officials said data collected from a large number of patients granted access to the therapy through a program administered by the Mayo Clinic had made a compelling case for authorization. FDA Commissioner Stephen Hahn said researchers had seen a 35% improvement in survival for patients treated with convalescent plasma