FDA Amends Emergency Use Authorization for COVID-19 Convalescent Plasma

The FDA has revised its Emergency Use Authorization (EUA) for COVID-19 convalescent plasma, allowing only plasma with high antibody titers and only for hospitalized patients with early infections or patients with impaired immunity.

The use of plasma from recovered COVID-19 patients as a treatment for infected patients “has not been associated with clinical benefit” in hospitalized patients late in the course of illness, the agency said, citing results from clinical trials.

“As additional scientific evidence about COVID-19 convalescent plasma emerged, we revised the EUA to reflect the updated evidence,” said Peter Marks, director of the Center for Biologics Evaluation and Research. “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,” he said.

The FDA controversially granted an EUA in late August for the use of convalescent plasma in treating COVID-19 patients, in a move decried by some experts as lacking supporting data for the treatment’s clinical benefit and safety (DID, Aug. 24, 2020). The agency updated the authorization in late November to require an additional qualifying test for manufacturers of the convalescent plasma.

In its newly amended EUA, the FDA specifies seven additional tests that may now be used by manufacturers to qualify high-titer COVID-19 convalescent plasma, but it noted that the use of any other test would require a further amendment to the EUA.

Read the revised letter of authorization and EUA decision memorandum here: www.fdanews.com/02-05-21-COVID19.pdf. ― Jason Scott