Citing the latest available data, the U.S. Food and Drug Administration (FDA) has revised the Emergency Use Authorization (EUA) for COVID-19 convalescent plasma therapy.
High-titer COVID-19 convalescent plasma can be used only in hospitalized patients who are early in the disease course and those with impaired humoral immunity who cannot produce an adequate antibody response, according to the FDA.
The original EUA for convalescent plasma was issued in August 2020 with no restrictions. However, recently, the FDA has curbed the use of the therapy after taking new clinical trial data into consideration.
Dr. Peter Marks, Director, FDA Center for Biologics Evaluation and Research, said, “This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients.”
The agency said, “COVID-19 convalescent plasma used according to the revised EUA may have efficacy, and its known and potential benefits outweigh its known and potential risks.”
The FDA also said it revoked the use of low-titer COVID-19 convalescent plasma based on new data from clinical trials that have failed to demonstrate that low-titer convalescent plasma therapy may be effective in treating hospitalized COVID-19 patients.
The new guidance has also noted that transfusion of COVID-19 convalescent plasma has not been found effective when given late in the disease course, following respiratory failure requiring mechanical ventilation.
The FDA’s revised EUA has also included several additional tests that can be used to manufacture convalescent plasma.
The agency said, “With this update, nine tests are now included in the EUA for testing plasma donations for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release.” The article was originally published Friday on Medscape Medical News.
