FDA Halts Approval for Plasma to Treat COVID-19
Aug. 20, 2020 — U.S. Food and Drug Administration’s emergency approval of blood plasma as a COVID-19 treatment was put on hold last week after senior federal health officials said data supporting the therapy was too weak.
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 and Infectious Diseases, The New York Times reported.
Plasma donated by people who’ve survived COVID-19 has high levels of antibodies against the disease and is considered safe, but clinical trials have not proven that it can help COVID-19 patients.
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 patient and is the largest such study in the U.S, The Times reported.
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.
“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.
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.
“We want to make sure that when we say it works, we are confident, with indisputable evidence,” she told The Times. “We’re dealing with patients’ lives here.”
An FDA spokeswoman declined to comment on the matter, The Times reported.
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 to treat patients with the disease has attracted considerable attention as a potential therapy while scientists try to develop vaccines against the coronavirus that causes COVID-19.