NIH expands plasma studies, raising questions about FDA’s emergency authorization

NIH Tuesday announced the expansion of two randomized, placebo-controlled trials of convalescent plasma to treat COVID-19. The trials, and NIH’s decision not to include convalescent plasma in COVID-19 treatment guidelines, raise questions about FDA’s emergency use authorization of the therapy.

In a Sept. 1 statement, NIH’s COVID-19 Treatment Guidelines Panel told clinicians “there are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.” It added that convalescent plasma “should not be considered standard of care for the treatment of patients with COVID-19,” and called for randomized clinical trials. ...