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.
“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 remarks, however, exaggerated actual results. In fact, patients treated with plasma containing the highest levels of antibodies were 35% more likely to survive than those who got plasma with lower levels.
It’s not yet known whether patients treated with plasma are less likely to die than those who aren’t treated with the substance at all.
Nonetheless, 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.
Shares of Grifols SA of Spain, which Equita analyst Gianmarco Bonacina described as a major provider of plasma derivatives in the U.S., rose as much as 4%.
Some infectious-disease specialists say that scientists should continue to study the use of convalescent plasma in clinical trials before expanding access to the treatment.
Thomas M. File, the president of the Infectious Diseases Society of America, said in a statement that the group “supports the continued collection of data in clinical trials to better understand the benefits of convalescent plasma treatment before authorizing its wider use in patients with Covid-19.”
Several clinical trials are ongoing, but many have had problems recruiting participants due to the expanded-access program run by the Mayo Clinic, which provides the therapy to all patients. In a clinical trial, some patients are randomly administered a placebo.
Trump’s chief of staff, Mark Meadows, earlier Sunday blamed federal officials for slowing the U.S. response to the virus pandemic, which has killed more than 175,000 Americans so far, ahead of what had been touted as a “therapeutic breakthrough.”
The coronavirus outbreak is weighing heavily on Trump’s re-election prospects. About 58% of Americans disapprove of his handling of the pandemic, while 40% approve, according to a RealClearPolitics average of polling on the question.
While the U.S. still has the world’s highest death toll, coronavirus-related fatalities in the country fell below 1,000 for the first time in five days. Texas, Florida and Arizona all reported drops in cases and deaths.