The Food and Drug Administration’s emergency authorization for blood plasma as a treatment for the coronavirus has been put on hold to obtain more data, according to a report.
An emergency service approval could still be issued by the FDA in the very near future, H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, told the New York Times.
Several top health experts – including Dr Anthony Fauci and Dr Francis Collins, director of the National Institutes of Health – intervened last week, saying data on treatment was too weak, two senior administration officials told the newspaper.
Donated by patients who have survived COVID-19, antibody-rich plasma has been considered safe, but clinical studies have not shown whether it can help people fight the disease.
Fauci, a member of the White House coronavirus task force, Lane and Collins urged fellow experts to stop, citing emerging data from the country’s largest plasma study by the Mayo Clinic.
“The three of us are pretty attuned to the importance of robust data through randomized counter-tests, and that a pandemic that does not change,” Lane told the Times on Tuesday.
The emergency authorization was based on the history of plasma use in other disease outbreaks, as well as on animal research and several studies, including Mayo’s program, the report reported.
An FDA spokesman declined to comment to the Times.
FDA researchers studied 20,000 patients who doctors believed could progress to worse than life-threatening stages of COVID-19, according to a recent CNN report.
They received the so-called convalescent plasma between April 3 and June 11 for the study, which was published in Mayo Clinic Proceedings.
The treatment – which has been used to treat knives, flu and Ebola – takes advantage of the fact that people recovering from an infection develop virus-fighting antibodies in their blood.
Transfusions of their convalescent plasma – the clear fluid after blood cells have been removed – can boost recipients’ immune systems in fighting the virus.
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