President Trump on Aug. 23 announced that the U.S. Food and Drug Administration issued an emergency-use authorization for the use of convalescent plasma to treat covid-19, adding that it’s “safe and very effective.”
The FDA, which appeared to rush with an announcement on Sunday, said early evidence suggests blood plasma can decrease mortality and improve the health of patients when administered in the first three days of their hospitalization.
It was not immediately clear what the immediate impact of this decision would be.
“It appeared that the product is safe and we’re comfortable with that and we continue to see no concerning safety signals,” said Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research said on a conference call with reporters.
The agency also said it determined this was a safe approach in an analysis of 20,000 patients who received this treatment. So far, 70,000 patients have been treated using blood plasma, the FDA said.
Patients who benefited the most from this treatment are those under 80 years old and who were not on a respirator, the agency said. Such patients had a 35 percent better survival rate a month after receiving the treatment.
FDA Director Stephen Hahn said Trump had not spoken to him or the agency and did not play a role in its decision to make the announcement on Sunday.