The agency's Covid-19 Treatment Guidelines Panel stated there was insufficient evidence for or against the treatment and pointed out that in certain groups, such as intubated patients, no benefit in seven-day overall survival was observed.
While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA's move fueled suspicions that political pressure - rather than science and data alone - may have played a role.
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Over the weekend, Trump called the agency, without evidence, part of a "deep state" that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.
The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.
Fewer than 100 people so far have been treated with plasma through the emergency avenues approved by the FDA, according to the AABB, an international nonprofit focused on transfusion medicine and cellular therapies.