FDA Issues EUA for Convalescent Plasma as COVID-19 Treatment

In a surprise U-turn, the FDA on Sunday authorized the emergency use of convalescent plasma for treating COVID-19, following accusations by President Trump that the agency was holding off on issuing an Emergency Use Authorization (EUA) for political reasons.

FDA Commissioner Stephen Hahn said during a Sunday evening press conference that agency experts, after analyzing the data from the agency’s expanded access program and more than a dozen published studies, concluded the treatment was safe and held promise for COVID-19 patients. More than 70,000 patients have already received the plasma treatment.

“In the optimal patients treated with convalescent plasma at the highest titers, there was a 35 percent improvement in survival, which is a significant clinical benefit,” Hahn said. “We’re going to continue to gather data, but this clearly meets the criteria that we’ve established for EUA, and we’re very pleased with these results.”

The decision flies in the face of advice from prominent experts. NIH Director Francis Collins and National Institute for Allergy and Infectious Diseases Director Anthony Fauci had warned about the risks of issuing an EUA based on the data collected to date.

HHS Secretary Alex Azar, who also spoke at the press conference, said that the patients who benefited the most on convalescent plasma were under age 80 and not on artificial respiration, calling the findings “a major advance in the treatment of patients.”

“I don’t want you to gloss over this number,” he said. “We dream, in drug development, of something like a 35 percent mortality reduction.”

The EUA allows the treatment to be given by healthcare providers for suspected or laboratory-confirmed COVID-19 in hospitalized patients, and “current data suggest the largest clinical benefit is associated with high-titer units of [convalescent plasma] administered early in the course of disease,” the agency said.

The decision is a reversal from the agency’s previous decision less than a week ago to hold off on issuing the EUA until more data became available. The FDA’s hesitation drew criticism from President Trump, who claimed the agency was waiting until after the U.S. presidential election to grant the emergency authorization (DID, Aug. 21).

But former FDA Commissioner Scott Gottlieb disagreed with Trump’s accusation, saying in a televised interview that he “firmly reject[s] the idea that [the FDA] would slow walk anything, or accelerate anything for that matter, based on any kind of political consideration.” Gottlieb added that he believes convalescent plasma is “probably beneficial.”

Still, the EUA drew immediate criticism from some experts, who contend that more studies are  needed to prove the treatment’s safety and efficacy. Former FDA Commissioner Robert Califf said, “we need well-designed, randomized controlled trials to be sure” about convalescent plasma. — James Miessler