The United States Food and Drug Administration (FDA) on Sunday said it authorized the use of blood plasma from patients who have recovered from COVID-19 as a treatment for the disease, in a series of tweets after a press conference at the White House.
“Today, we issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of hospitalized COVID-19 patients as part of the agency’s ongoing efforts to fight #COVID19”, the Agency said.
The US FDA said EUA authorizes the distribution of Covid-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized COVID-19 patients.
“A 35 percent improvement in survival is a pretty substantial clinical benefit,” FDA Commissioner Stephen Hahn said in relation to the convalescent plasma emergency use authorization issued today.
“We’re going to continue to gather data, but this clearly meets the criteria that we’ve established for emergency use authorization, and we’re very pleased with these results.” — Hahn continued.
The FDA said it’s research has determined that it is reasonable to believe that Covid19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some patients.
“Additionally, the known and potential benefits of the product, when used to treat #COVID19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments”, the Agency added.
“I am committed to releasing safe and potentially helpful treatments for #COVID19 as quickly as possible in order to save lives,” said Hahn.
“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.