The Food and Drug Administration gave emergency approval to a coronavirus 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 vaccines 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. “We’re going to continue to gather data but this clearly meets the criteria that we’ve established for emergency use authorization.”
Health Secretary Alex Azar said the treatment worked best in patients under 80 and showed a 35% mortality reduction. He said the U.S. hopes to have additional therapeutics this fall in its fights against the virus that’s killed over 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 said the emergency use authorization, or EUA, will dramatically expand the use of the treatment that’s so far been given to roughly 70,000 patients through a Mayo Clinic study.
“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 the coronavirus to sign up to donate.
Mr. Trump announced the approval less than 48 hours after the president tweeted that FDA employees were making it hard for people to enroll in trials because they didn’t want the results until after Election Day.
The president on Sunday said 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 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-3 human trials.
Yet the looming 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, since they are administered to healthy people as opposed to 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.”
