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NIH panel contradicts FDA on authorization for convalescent plasma in Covid-19

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A panel of experts at the National Institutes of Health is casting doubt on the decision by the Food and Drug Administration to authorize convalescent plasma as a treatment for Covid-19.

The FDA granted an emergency use authorization, or EUA, for convalescent plasma on Aug. 23, in a move that President Donald Trump heralded as a “very historic breakthrough,” but that also drew accusations that it was granted under political pressure. In a press conference to announce the EUA, FDA Commissioner Stephen Hahn grossly mischaracterized the treatment’s benefits, stating that 35 out of 100 people “would have been saved” with it, a claim he subsequently walked back and for which he apologized.

But the NIH’s Covid-19 Treatment Guidelines Panel questions the treatment’s overall benefit too. The panel comprises experts from within the NIH as well as academic institutions.

In contrast with the FDA, the panel stated there are “insufficient data to recommend either for or against” convalescent plasma as a Covid-19 therapy and that it should not be considered standard-of-care, calling for randomized controlled trials with sufficient statistical power to determine its safety and effectiveness. While long-term safety remains unclear, the panel noted that serious adverse events have been infrequent.

“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,” a statement from the panel read.

The EUA was based on a subset analysis from the Mayo Clinic’s Expanded Access Program, or EAP, which compared convalescent plasma with high concentrations, also known as titers, of antibodies against the SARS-CoV-2 virus with plasma with lower concentrations in hospitalized patients, including those who were intubated and those who were not.

The panel’s statement pointed out that there was no difference in overall survival after seven days among patients receiving high- and low-antibody plasma. Among those who were not intubated, 11% of those receiving high-antibody plasma died within seven days, compared with 14% among those receiving low-antibody plasma. However, no difference was observed among patients who were intubated.

“Although these 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 in the Mayo Clinic’s EAP,” the statement read. “Additionally, antibody levels in currently available Covid-19 convalescent plasma are highly variable, and assays to determine the effective antibody titers remain limited.”

Photo: National Institutes of Health

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