NIH Cautions There Is ‘Insufficient Data’ To Show ‘Efficacy and Safety’ of Trump-Touted COVID-19 Treatment

President Donald Trump is optimistic that convalescent plasma will be a game-changer in the fight against COVID-19.

On August 23, the Food and Drug Administration (FDA) announced it had granted an Emergency Use Authorization (EUA) for convalescent plasma, as IJR reported.

However, the National Institutes of Health (NIH) released a statement on findings compiled by The COVID-19 Treatment Guidelines Panel regarding the treatment.

“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 panel found.

“The FDA analysis of data on a subset of hospitalized patients from the Mayo Clinic’s Expanded Access Program (EAP) compared outcomes in patients who received convalescent plasma with high titers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies to outcomes in patients who received plasma with low titers and found no difference in 7-day survival overall.”

“Among patients who were not intubated, 11% of those who received convalescent plasma with high antibody titers died within 7 days of transfusion compared with 14% of those who received convalescent plasma with low antibody titers. Among those who were intubated, there was no difference in 7-day survival,” the statement added.

The NIH said that “data suggest that convalescent plasma with high antibody titers may be beneficial in nonintubated patients.”

However, it cautioned that “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.”

“Based on the available evidence, the Panel has determined the following,” the statement continued. “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.”

Additionally, the panel said that “serious adverse” reactions to convalescent plasma are “infrequent and consistent with the risks associated with plasma infusions for other indications.”

However, the panel did not examine the “long-term risks” of using convalescent plasma to treat COVID-19 or whether it could actually hurt a person’s immune response to the virus and make them “more susceptible to reinfection.”

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

Finally, the panel said “well-controlled, adequately powered randomized trials” are necessary to determine if convalescent plasma is effective.

Last week Trump announced that the FDA has issued the (EUA) and called it a “powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection.”

However, officials at the FDA have now been accused of exaggerating the effectiveness of convalescent plasma, as IJR reported.

The New York Times reports that the EUA is now on hold as researchers conduct more tests to study the effectiveness and safety of the treatment.