FDA Expands Access to Plasma Covid Therapy Before Trials Finish

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.”

Watch: Trump says a coronavirus treatment that involves blood plasma donated by people who’ve recovered from the disease will be expanded to many more sick Americans after the FDA approved use of the therapy.

(Source: APTN/Bloomberg)

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%.

Blame for Slowdown

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.

After Trump claimed Saturday that FDA employees were engineering delays to sabotage his re-election, Meadows said the president’s tweet reflected “frustration” with bureaucrats in the agency.

“They want to do things the way they’ve always done it,” Meadows said on ABC’s “This Week.” “This president is about cutting red tape. That’s what the tweet was all about.

Meadows suggested part of the reason Trump tweeted about the FDA is that he wants to make federal health agencies “feel the heat” to deliver results. On “Fox News Sunday,” Meadows said “the announcement that’s coming today should have been made several weeks ago.”

“It was a fumble by a number of people in the federal government that should have done it differently, and having been personally involved with it, sometimes you have to make them feel the heat if they don’t see the light,” he said.

Commercial Distribution

Former FDA Commissioner Scott Gottlieb, who left the Trump administration in April 2019, said Sunday on CBS that there were “perceived delays” in making the authorization for blood plasma because of worries among top health officials.

“It was reported this week that [the National Institutes of Health] had misgivings about FDA going forward with that authorization. But there’s reasons people have some questions,” Gottlieb said on “Face the Nation.” “The trial that -- that’s going to be based on, 70,000 patients, wasn’t a very vigorously done trial.”

The emergency use order will probably allow more commercial distribution “and it will allow manufacturers of plasma products to more easily recoup the cost,” he said. “But the bottom line is, it’s widely available right now. Patients are getting it.”

Separately, the Financial Times reported on Sunday that Trump is considering whether to bypass normal U.S. regulatory standards to fast-track an experimental coronavirus vaccine from the U.K. for use in the U.S. before November’s election, via an EUA.

A spokesman for HHS, which oversees the FDA, told the newspaper any claim that an emergency-use authorization would be issued before the election was “absolutely false.”

Data Distinction

The Mayo Clinic’s data, posted on a website used by researchers to disseminate their results before they are ready to be formally published, showed that patients getting convalescent plasma with the highest levels of antibodies were 35% more likely to survive than those who got lower levels. While treatment with higher antibody levels improved survival, all of the patients received convalescent plasma.

That distinction was papered over during Trump’s news conference, where the president said the therapy was proven “very effective” and Hahn said the product itself -- not its precise composition -- was saving lives.

“A 35% improvement in survival is a pretty substantial clinical benefit,” Hahn said. “What that means is that, if the data continue to pan out, 100 people who are sick with Covid 19, 35 would have been saved by the administration of plasma.”

What the study actually showed was that treating those 100 people who would have otherwise died with higher antibody levels saved 35 lives, compared with giving all of them plasma units with lower doses of antibodies. It doesn’t shed any light on how they would have fared compared to standard treatment.

--With assistance from Yueqi Yang, Greg Chang, Anna Edney and Jeannie Baumann.

To contact the reporters on this story:
Jordan Fabian in Washington at jfabian6@bloomberg.net;
Kevin Cirilli in Washington at kcirilli@bloomberg.net;
Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editors responsible for this story:
James Ludden at jludden@bloomberg.net

Timothy Annett, Alex Wayne

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