The Food and Drug Administration on Sunday issued an emergency use authorization of convalescent plasma for the treatment of COVID-19 in patients.
The FDA announced the emergency authorization shortly before President Donald Trump echoed the announcement at a White House news conference.
"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," Trump said.
“To deliver treatments and vaccine to save lives, we’re removing unnecessary barriers and delays—not by cutting corners, but by marshaling the full power of the federal government,” the president added.
In an announcement shortly before the president spoke, the FDA said that “based on scientific evidence available” it had concluded the plasma “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.”
The agency said the emergency use authorization follows its “extensive review of the science and data generated over the past several months.”
“The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19,” the FDA said.
Health and Human Services Secretary Alex Azar said, “The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19.”
FDA Commissioner Stephen Hahn said, “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma."
"The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus," Hahn said, adding that randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating COVID patients will continue.
The FDA says convalescent plasma is the liquid part of blood that is collected from patients who have recovered from the coronavirus. COVID patients develop antibodies in their blood against the virus that could potentially help current patients battle the disease.
"Convalescent plasma is being investigated for the treatment of COVID-19 because there is no approved treatment for this disease and there is some information that suggests it might help some patients recover from COVID-19," the FDA says.
The White House had wanted the FDA to approve blood plasma authorization. On ABC's “This Week” Sunday, White House chief of staff Mark Meadows said, "This president is about cutting red tape."
“We really need to make sure that we have good science and the proper protocol,” Meadows said. “But we also can’t wait around and assume that this virus is going to go away. This president wants real results and that’s why he took to Twitter.”
White House press secretary Kayleigh McEnany touted Trump press conference on Saturday, tweeting that he would be announcing a "major therapeutic breakthrough" on the coronavirus.
On Saturday, Trump accused the FDA, without evidence, of delaying coronavirus treatments to hurt his reelection bid.
In a tweet in which he tagged Hahn, the president wrote: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
House Speaker Nancy Pelosi responded to Trump's tweet, writing: “The FDA must approve drugs or vaccines based on their safety and effectiveness – NOT political pressure from the White House.”
“The President’s dangerous attempt to inject himself into the scientific decisions of the FDA jeopardizes the health & well-being of all Americans,” she continued.