EBS - FDA Authorizes Plasma Antibodies as a COVID-19 Treatment
The Food and Drug Administration (FDA) issued an emergency use authorization yesterday for the utilization of convalescent plasma as a treatment for COVID-19. Convalescent plasma contains antibodies against the novel coronavirus that causes COVID-19. The plasma is harvested from patients who have recovered from the disease.
"The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients," the agency said in a press release announcing the decision.
If "reasonable" doesn't sound like a ringing endorsement, that's because it isn't. The authorization is based on two small randomized clinical trials -- neither of which reached statistical significance. The authorization also included data from nonrandomized studies and data on patients treated under an expanded access program, both of which don't have a control group, making the data hard to interpret.