NIH Panel Counters FDA: No Solid Data on Plasma for COVID-19

NIH Panel Counters FDA: No Solid Data on Plasma for COVID-19

Marcia Frellick

September 02, 2020

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Current data are insufficient to recommend either for or against using convalescent plasma to treat patients who have COVID-19, the National Institutes of Health's (NIH) COVID-19 Treatment Guidelines Panel said Tuesday.

Alex Azar

"Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19," the committee said.

The NIH statement comes just more than a week after the US Food and Drug Administration (FDA) on August 23 issued an emergency use authorization (EUA) promoting the use of convalescent plasma in treating patients hospitalized with COVID-19. In the FDA statement announcing the EUA, Health & Human Services Secretary Alex Azar called it "a milestone achievement."

The COVID-19 Treatment Guidelines Panel, made up of physicians, statisticians, and other experts, rejected that interpretation of the data.

"[T]hough data suggest that convalescent plasma with high antibody titers may be beneficial in nonintubated patients, uncertainty remains about the efficacy and safety of convalescent plasma due to the lack of a randomized control group and possible confounding," the NIH panel concluded after reviewing published and unpublished data on convalescent plasma for treating COVID-19, including the FDA analyses that led to the EUA.

The panel notes that serious adverse reactions after the administration of COVID-19 convalescent plasma are infrequent, which is "consistent with the risks associated with plasma infusions for other indications."

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