Trump lauds FDA emergency approval of convalescent plasma as coronavirus treatments

The Food and Drug Administration gave emergency approval to a COVID-19 treatment that uses antibodies in the blood plasma of survivors to help patients fend off the disease, one day after President Trump accused “deep state” figures at the agency of slow-walking therapeutics and vaccine trials to make him look bad.

FDA Commissioner Stephen Hahn said he was encouraged by early data that suggested “convalescent” plasma can lessen the severity of disease or shorten the length of COVID-19 in some patients. His agency looked at an expanded-access program through the Mayo Clinic and a dozen other studies.

“Those scientists have concluded that COVID-19 convalescent plasma is safe,” Dr. Hahn said at a White House press briefing with President Trump Sunday evening. “We’re going to continue to gather data, but this clearly meets the criteria that we’ve established for emergency use authorization.”

Health and Human Services Secretary Alex M. Azar II said the treatment worked best in patients younger than 80 and showed a 35% reduction in mortality. He said the U.S. hopes to have additional therapeutics in the fall as it fights COVID-19, which has killed more than 176,000 people in the U.S.

Convalescent plasma is taken from the liquid part of blood and contains antibodies that can help patients fight off the virus. It is part of a trinity of promising treatments that also includes an antiviral drug, remdesivir, and a steroid, dexamethasone.

Mr. Trump hailed the emergency use authorization, or EUA, as a breakthrough that will dramatically expand the ability of doctors to use the treatment, which has been given to roughly 70,000 patients through the Mayo Clinic program.

“That’s such as powerful term: emergency use authorization,” Mr. Trump said. “This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients.”

He encouraged Americans who recover from COVID-19 to sign up to donate.

Mr. Trump announced the approval less than 48 hours after the president tweeted that FDA employees were making it difficult for people to enroll in trials because they didn’t want the results until after Election Day.

The president said Sunday that he “broke the logjam.”

Mr. Trump has been nudging scientists and regulators to move at record-breaking speed throughout the pandemic, given the scale of the crisis.

His administration has offered billions of dollars of support to drug companies willing to take on the risk of developing drugs for a pandemic that should eventually fade while securing millions of doses of vaccine candidates that have entered phase three human trials.

Yet the looming Nov. 3 presidential election has public health experts, Democrats and others fretting about undue political pressure on regulators, who must closely vet treatments and vaccines to ensure they “do no harm.”

Vaccines have an especially high bar because they are administered to healthy people rather than the sick and desperate.

Mr. Trump’s first FDA commissioner, Scott Gottlieb, said there were reported misgivings at the National Institutes of Health about moving forward with the emergency authorization for using plasma to treat COVID-19.

“The trial that that’s going to be based on, 70,000 patients, wasn’t a very rigorously done trial. It was an open-label study where everyone got treated. So it’s hard to draw conclusions,” Dr. Gottlieb told CBS’s “Face the Nation.”

But Mr. Trump was getting impatient with FDA regulators.

“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,” he tweeted Saturday. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

White House Chief of Staff Mark Meadows, speaking to “Fox News Sunday,” defended the president’s tweet. He said regulators should have made progress on some issues weeks ago.

“Sometimes you have to make them feel the heat if they don’t see the light,” Mr. Meadows said.

The use of plasma from people who have recovered to treat patients with the same illness dates back to the 1890s and confers what is known as “passive” immunity because recipients don’t produce their own antibodies but use donors’ antibodies.

Mr. Trump visited the American Red Cross headquarters in Washington last month to promote the treatment and cheer a COVID-19 survivor, Marty Sarsfield, as he donated his plasma in a basement room.

The coronavirus that causes COVID-19 was discovered in Wuhan, China, in December and swiftly spread around the globe.

The worldwide death toll crossed 800,000 over the weekend. Compounding the woe in hard-hit Peru, 13 people died late Saturday as police raided a Lima nightclub that was violating coronavirus regulations.

The U.S. has the highest death toll in the world, at more than 176,000, followed by Brazil at 114,000 and Mexico at over 60,000.

A protester in a grim reaper costume held a “176k” sign as Mr. Trump’s motorcade entered the Trump National Golf Club in Sterling, Virginia, for the second time in as many days on Sunday.

A CBS News/YouGov Poll released Sunday said 57% of Republicans think the number of U.S. deaths from COVID-19 has been acceptable, compared with 33% of independents and 10% of Democrats.

Cases are rising in parts of the Midwest, but progress has been made in recent weeks after a surge of COVID-19 across the Sun Belt. The seven-day rolling average of reported infections in the U.S. is below 44,000 per day, down from more than 60,000 at the start of the month.

Los Angeles Mayor Eric Garcetti said Sunday that his city has made progress after a severe surge in California this summer.

He said California has driven down its hospitalization rate and about 6% of tests are returning positive. Experts recommend a positivity rate of lower than 10% to ensure they are catching enough cases in the community.

Also Sunday, Mr. Garcetti defended his practice of shutting down the utilities of places that hold house parties. He said they could become superspreaders of COVID-19.

“Where people don’t listen,” he said, “we’re going to shut them down.”