WASHINGTON — The Food and Drug Administration announced Sunday that it has authorized the use of blood plasma from patients who have recovered from Covid-19 as a treatment for the disease.
The decision to issue an emergency use authorization, which President Trump’s press secretary heralded ahead of time as a “major therapeutic breakthrough,” likely falls far short of that description — and could generate intense controversy inside the administration and the broader scientific community.
So-called convalescent plasma is among a host of potential therapeutics that have been undergoing testing in clinical trials. The hope is that infusions of antibody-rich plasma from those who have recovered from Covid-19 can be injected into ill patients, kickstarting their immune system and allowing them to fight off the virus until they can generate their own antibodies.
“Today’s action will dramatically expand access to this treatment,” Trump said at a White House news conference Sunday afternoon. He called the EUA a “truly historic announcement” and said that convalescent plasma has been proven to reduce mortality by 35%, which he called a “tremendous number.”
Alex Azar, secretary of Health and Human Services, followed Trump. “We dream in drug development of something like a 35% mortality reduction,” he said. “This is a major advance in the treatment of patients.”
An FDA staffer who reviewed the data on convalescent plasma — and whose name was redacted from a memo released by the agency — was far less enthusiastic, writing that the data “support the conclusion that [convalescent plasma] to treat hospitalized patients with COVID-19 meets the ‘may be effective’ criteria for issuance of an EUA. Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of … efficacy and to determine the optimal product attributes and the appropriate patient populations for its use.”