As the U.S. Centers for Disease Control and Prevention (CDC) on Sunday said the number of deaths due to the Coronavirus (COVID-19) had risen by 1,006 to 175,651 and 5,643,812 confirmed cases, President Donald Trump announced that the Food and Drug Administration (FDA) has authorized convalescent plasma for emergency use to treat patients sickened by the novel coronavirus.
President Trump, who has been looking to announce progress in fighting the virus, touted the news as a “historic breakthrough” at a White House news conference on Sunday, saying it would “dramatically expand access to this treatment.”
Sunday’s announcement came on the eve of the start of the Republican National Convention, where Trump is seeking a political boost in his battle for reelection against Democratic nominee, Joe Biden,
At the Democratic National Convention last week, many prominent Democrats focused their criticism on Trump’s handling of the coronavirus, which has infected roughly 5.7 million Americans in total and killed over 176,000 in the United States.
Experts have expressed optimism about the treatment, but former FDA Commissioner Scott Gottlieb called it “incremental” earlier on Sunday, noting that convalescent plasma is already available to thousands of patients, though the new announcement might make it somewhat more widely available.
“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,” FDA Commissioner Stephen Hahn said in a statement.
Hahn added that the agency will continue to work with researchers “to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
Some experts have raised concerns that the plasma is already so widely available that it is hindering the ability to study exactly how well it actually works, through randomized clinical trials, which have been struggling to recruit volunteers, given that many patients can get the treatment even outside a trial.
“I’ve been optimistic about convalescent plasma as therapy. But optimism isn’t science,” tweeted Ashish Jha, director of the Harvard Global Health Institute. “We need results of adequately powered randomized trials. Issuing an EUA without it would make such trials harder. And erode the credibility of the FDA.”
The announcement comes as Trump has attacked the FDA in an extraordinary way, accusing the “deep state” in the agency of slowing down the development of treatments and vaccines, raising concerns about the politicization of the agency’s approvals.
Hahn stood alongside Trump at the press conference and said that data so far has shown a 35 percent improval in survival for those treated with convalescent plasma.
Health and Human Services Secretary Alex Azar described the development as a “milestone achievement in President Trump’s efforts to save lives from COVID-19.”
Convalescent plasma is created from blood of individuals who have recovered from the coronavirus and has been used to treat other viruses like MERS, SARS and Ebola.
Convalescent plasma has already been used to treat roughly 70,000 Americans who have contracted the coronavirus.
Gottlieb, a former FDA commissioner under Trump, said on CBS’ “Face the Nation” earlier Sunday that granting emergency use authorization for the treatment would allow for “easier access in certain settings,” but he noted that it is already widely available.
“What the emergency use authorization will allow is probably more commercial distribution and it will allow manufacturers or plasma products to more easily recoup the costs,” Gottlieb said.
“The bottom line is, it’s widely available right now. Patients are getting it,” he continued. “It’s incremental, and incremental gains are important here but we need to view it for what it is.”
Trump has been a vocal proponent for convalescent plasma as a treatment for COVID-19, and has publicly urged individuals who have recovered from the virus to donate their plasma.
Trump suggested to reporters at a news briefing last week that the FDA was playing politics in its decisions regarding emergency use authorization for convalescent plasma. Trump said he didn’t want any “delays” in the decision process.
He targeted the FDA in a tweet over the weekend, suggesting that the agency was delaying vaccine trials until after the November election. He accused FDA officials of being part of the so-called “deep state” in government working against him.
“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!” Trump wrote, tagging Hahn in the tweet.
