NIH questions evidence backing FDA's emergency authorization for convalescent plasma as COVID-19 treatment

There is no data from well-controlled, randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for treating COVID-19, according to a statement issued Sept. 1 by the National Institutes of Health, which undercuts the FDA's emergency use authorization.

The FDA issued the emergency use authorization for convalescent plasma as a treatment for hospitalized patients with COVID-19 Aug. 23. But the NIH's COVID-19 Treatment Guidelines Panel reviewed the available evidence from published and unpublished data and found that there is not enough evidence to recommend for or against the use of convalescent plasma as a COVID-19 treatment.

The FDA issued the authorization based on analysis of data from a subset of hospitalized patients in Rochester, Minn.-based Mayo Clinic's expanded access program. But the safety and efficacy of convalescent plasma based on this data is suspect due to the "lack of a randomized control group and possible confounding" in the expanded access program, the NIH states.

"Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19," the statement reads. "Prospective, well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe for the treatment of COVID-19."

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