FDA Halts Approval for Plasma to Treat COVID-19
August 20, 2020 – Emergency approval of blood plasma by the United States Food and Drug Administration as a COVID-19 treatment was suspended last week after senior federal health officials said the data supporting treatment were too weak.
More data is under review and approval may still be issued in the near future, according to H. Clifford Lane, clinical director of the National Institute of Allergy and Infectious Diseases, The New York Times reported.
Plasma donated by people who are COVID-19 survivors has high levels of antibodies to the disease and is considered safe, but clinical trials have not proven that it can help patients with COVID-19 .
The proposed emergency approval was based on the history of the use of plasma in the treatment of other diseases, animal research, and a number of plasma studies, including research from the Mayo Federally funded clinic that has tested plasma in over 66,000 COVID-19 patients and is the largest such study in the United States, The temperature reported.
However, a number of prominent health officials – including Lane, the director of the National Institutes of Health, Dr Francis Collins, and Dr Anthony Fauci, the government’s top infectious disease specialist – have warned the last week that the data available from the Mayo study was not strong enough to support emergency approval.
“The three of us are pretty aligned with the importance of robust data through randomized controlled trials, and a pandemic doesn’t change that,” Lane said. The temperature.
Emergency approval at this point “would change the way people view trials,” says Dr. Mila Ortigoza, an infectious disease specialist at NYU Langone Health who has started a plasma clinical trial with colleagues at Montefiore Medical Center .
“We want to make sure that when we say it works, we are confident, with compelling evidence,” she said. The temperature. “We take care of the lives of patients here.”
An FDA spokeswoman declined to comment on the case, The temperature reported.
Plasma is the pale fluid that remains after removal of red and white blood cells from the blood. The use of plasma from people who have recovered from COVID-19 to treat patients with the disease has attracted considerable attention as a potential therapy as scientists attempt to develop vaccines against the coronavirus that causes COVID- 19.
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