THURSDAY, Aug. 20, 2020 (HealthDay News) — U.S. Food and Drug Administration’s emergency approval of blood plasma as a COVID-19<\/a> treatment was put on hold last week after senior federal health officials said data supporting the therapy was too weak.<\/p>\n More data is under review and the approval could still be issued in the near future, according to H. Clifford Lane, the clinical director at the National Institute of Allergy<\/a> and Infectious Diseases, The New York Times<\/i> reported.<\/p>\n Plasma donated by people who’ve survived COVID-19<\/a> has high levels of antibodies against the disease and is considered safe, but clinical trials<\/a> have not proven that it can help COVID-19<\/a> patients.<\/p>\n The proposed emergency approval was based on the history of plasma’s use in treating other diseases, animal research, and a number of plasma studies, including a federal government-financed Mayo Clinic research that’s tested plasma in more than 66,000 COVID-19<\/a> patient and is the largest such study in the U.S, The Times<\/i> reported.<\/p>\n However, a number of leading health officials — including Lane, National Institutes of Health Director Dr. Francis Collins, and Dr. Anthony Fauci, the government’s top infectious disease expert — cautioned last week that available data from the Mayo study wasn’t strong enough to support emergency approval.<\/p>\n “The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told The Times<\/i>.<\/p>\n An emergency approval at this stage would “change the way people view trials,” according to Dr. Mila Ortigoza, an infectious disease specialist at NYU Langone Health who started a plasma clinical trial with colleagues at Montefiore Medical Center.<\/p>\n “We want to make sure that when we say it works, we are confident, with indisputable evidence,” she told The Times<\/i>. “We’re dealing with patients’ lives here.”<\/p>\n An FDA spokeswoman declined to comment on the matter, The Times<\/i> reported.<\/p>\n Plasma is the pale liquid that remains after red and white cells are removed from blood. Using plasma from people who’ve recovered from COVID-19<\/a> to treat patients with the disease has attracted considerable attention as a potential therapy while scientists try to develop vaccines<\/a> against the coronavirus that causes COVID-19<\/a>.<\/p>\n <\/p><\/div>\n![\"MedicalNews\"](\"https:\/\/images.medicinenet.com\/images\/HealthDay\/healthday.png\")
Copyright \u00a9 2019 HealthDay. All rights reserved.<\/p>\n