A panel of experts at the National Institutes of Health on Tuesday weighed into the FDA's emergency use authorization (EUA) of convalescent plasma as a coronavirus treatment, stressing that "there are insufficient data to recommend either for or against" the use of plasma to treat COVID-19 patients.
Why it matters: President Trump and other officials pressured the FDA to grant an EUA for plasma despite warnings from public health experts, including those at the NIH, that data from randomized clinical trials was needed to determine the effectiveness of the treatment.
- The objections against the authorization continued after FDA Commissioner Stephen Hahn oversold the benefits of convalescent plasma as a coronavirus treatment at a press conference with President Trump. He later apologized.
What they're saying: "There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19," the NIH COVID-19 Treatment Guidelines Panel wrote.
- The panel added that convalescent plasma "should not be considered standard of care for the treatment of patients with COVID-19."
The bottom line: The NIH panel called for "prospective, well-controlled, adequately powered randomized trials" to "determine whether convalescent plasma is effective and safe for the treatment of COVID-19."
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