President Donald Trump on Sunday announced that the Federal Food and Drug Administration (FDA) had approved the use of convalescent plasma to treat coronavirus for emergency use. The president spoke about the approved treatment during a White House press conference on Sunday evening. “This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” Trump wrote. “It’s had an incredible rate of success.” The treatment takes convalescent plasma from blood donated from patients that have recovered from coronavirus. Under current FDA guidelines, convalescent plasma is regulated as an “investigative product.” “We broke the logjam over the last week,” Trump said when asked about the difficulty getting the treatment approved for emergency use by the FDA. The president thanked FDA administrator, Dr. Steven Hahn, for helping lead the project. “It is only made possible because of Operation Warp Speed. That is, everybody working together,” Trump said referring to his administration’s effort to speed treatments and vaccines for coronavirus. Trump said that approvals were years ahead of schedule and previewed exciting news about vaccines in the upcoming days. “We are removing unnecessary barriers and delays, not by cutting corners, but by marshaling the full power of the federal government,” he said. Hahn said that the expanded access program for convalescent plasma was started at the Mayo Clinic in April and over 70,000 people had received treatment. “This is one of the largest expanded access programs in the history of FDA, so a very successful approach to evaluating how convalescent plasma would work,” he said. Hahn said that the scientists at the FDA evaluated both the data from the program and over a dozen published studies before approving the treatment. In a June 3 article, the JAMA network outlined the history of the use of convalescent plasma dating as far back as the Spanish Flu epidemic and identified the treatment as a potential route to coronavirus containment. A later study published by the JAMA Network, however, concluded that the use of convalescent plasma as a treatment is less effective in severe coronavirus cases. “In the optimal patients, as described by Secretary Azar, treated with convalescent plasma at the highest tiers there was a 35 percent improvement in survival,” Hahn said. Hahn said that the FDA would continue evaluating the data and study the emergency use of the treatment. “We’re waiting for more data, and we’re going to continue gathering more data, but this clearly meets the criteria we’ve established for the emergency use authorization and we’re very pleased with these results,” he said. Hahn said that everyone recovering from the Covid-19 should act to donate their blood. “If you’ve recovered from Covid-19, please donate, you could save a life,” he said.
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