The Food and Drug Administration on Sunday issued an emergency use authorization for convalescent plasma to treat COVID-19.
Shortly after a news release by the FDA, President Donald Trump announced the authorization during a news conference on Sunday after promising a “therapeutic breakthrough” related to the virus.
The authorization allows convalescent plasma, which is used in an experimental treatment involving blood plasma transfusions from people who have developed antibodies to the new coronavirus, to be distributed by healthcare providers to treat people with COVID-19. Blood plasma has been used to treat other infectious diseases.
“This is a powerful therapy that transfuses very, very strong antibodies form the blood of recovered patients to help treat patients battling a current infection,” Trump said.
Health and Human Services Secretary Alex Azar said that more than 70,000 patients have been treated in studies of convalescent plasma for COVID-19 and the treatment has been used in response to MERS and SARS as well as the flue and Ebola.
Azar said there has been a 35% increase in survival through the treatment in patients under 80 who were not on artificial respiration.
“The data that we gathered suggested patients who were treated early in their disease course, within three days of being diagnosed, with plasma containing high levels of antibodies benefitted the most from treatment,” he said.
FDA administrator Stephen Hahn added that the independent judgment of FDA scientists has determined that COVID-19 convalescent plasma is “safe and shows promising efficacy” and thereby meets the criteria for an emergency use authorization.
He said that the authorization is “not the same as the approval” but allows the FDA to expand access to convalescent plasma.
“We will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus,” said Hahn.
In July, Trump encouraged virus survivors to visit coronavirus.gov to volunteer to donate their convalescent blood plasma and renewed that call on Sunday.
“I once again urge all Americans who have recovered from the virus to go to coronavirus.gov and sign up and donate plasma today,” he said.
Sunday’s announcement came after Trump tweeted earlier Saturday that the FDA was “making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.”
Last week, officials at the National Institutes of Health stopped the FDA from issuing what is known as an “emergency use authorization” for blood plasma to treat COVID-19. More data from randomized controlled trials, were needed, officials told The New York Times.
As of Sunday afternoon, COVID-19 has sickened 5.7 million Americans and killed 176,489 as, according to data collected by Johns Hopkins University.
Also Sunday, California, which leads the nation in cases, reported 6,777 new cases for a total of 663,669 and 146 new deaths for a death toll of 12,134.
The Florida Department of Health reported that the state had confirmed 2,974 new COVID-19 cases, its lowest single-day count since June, and 51 deaths among residents. The state has the second-highest case total in the nation at 600,571 and a resident death toll of 10,325.
Texas reported 4,398 new cases and is in third place with 577,537 total cases and 104 new deaths for a death toll of 11,370.
New York Gov. Andrew Cuomo on Sunday announced that COVID-19 hospitalizations dropped to 472, the lowest number in the state, which was once the epicenter for the virus in the United States, since March 16.
Cuomo also announced that the state reported 572 new confirmed cases for a total of 429,737 — fourth most in the nation — and five more deaths, adding to the nation’s highest death toll at 25,288.
Georgia is in fifth place in cases, reporting 1,727 new positives for a total of 253,949 and 40 new deaths for a total of 5,132.
North Carolina reported 1,472 new cases on Sunday for a total of 155,113 and 10 new deaths, bringing its death toll to 2,531.
Eastern Carolina University announced Sunday that all undergraduate students would move to online instruction for the remainder of the fall semester beginning Wednesday, citing “a rapid acceleration of COVID-19 cases, including multiple clusters” following the first two weeks of in-person classes.
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