President Donald Trump said a coronavirus treatment that involves blood plasma donated by people who have 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 is known as convalescent plasma for use in certain patients. The move would make it easier to receive the treatment.
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.
“We dream in drug development of something with a 35% mortality reduction,” Azar said. “This is a major advance in the treatment of patients.”
The authorization adds to a growing list of treatments available for doctors to fight Covid-19. In May, the FDA granted emergency authorization to the Gilead Sciences Inc. antiviral drug remdesivir. And an older steroid, dexamethasone, has become a widely embraced tool for fighting the virus.
Here are excerpts from President Trump’s press conference on Sunday announcing the convalescent plasma therapy:
President Trump: “Today, I am 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.”
President Trump: “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.”
President Trump: “We provided $48 million to fund the Mayo Clinic study that tested the efficacy of convalescent plasma for patients with the virus. Through this study, over 100,000 Americans have already enrolled to receive this treatment, and it is proven to reduce mortality by 35%.”
Secretary Azar: “Thanks for the bold leadership that allowed us to deliver this very happy news today. Thanks to your all of America approach, America has done more than any other country to expand the arsenal that we have to battle COVID-19.”
FDA Commissioner Hahn: “In the independent judgment of experts and expert scientists at FDA, who have reviewed the totality of data – not just the data from this expanded access program, but more than a dozen published studies, as well as the historical experience associated with this – those scientists have concluded that COVID-19 convalescent plasma is safe, ensures promising efficacy, thereby meeting the criteria for an Emergency Use Authorization.”