FDA Issues Emergency Authorization For Convalescent Plasma To Be Used As Treatment For COVID-19
NEW YORK (CBSNewYork) -- There is a new development in the fight against COVID-19.
The Food and Drug Administration has issued an emergency authorization for convalescent plasma treatment, CBS2's Ali Bauman reported Sunday.
The White House is heralding this as major therapeutic breakthrough, but it comes just days after the FDA held off on issuing an emergency use authorization at the urging of top health experts.
MORE: Max Minute: Convalescent Plasma Getting More Attention As Search Continues For COVID-19 Treatment
President Donald Trump's emergency authorization will allow the use of blood plasma from patients who have recovered from COVID-19 as a treatment for the virus.
Convalescent plasma is created from blood of recovered patients. It contains what doctors call "neutralizing antibodies," that can attach to the coronavirus and prevent it from infecting human cells.
Emergency use authorization does not require the same level of evidence as full FDA approval.
Last week, the agency put a hold on an emergency authorization for plasma treatment at the urging of Dr. Anthony Fauci and Dr. Francis Collins, the director of the National Institutes of Health.
On Saturday in a tweet, the president accused the FDA of deliberately delaying vaccine trials until after the November election. FDA Commissioner Stephen Hahn, who was nominated for the role by Trump, said the treatment meets the criteria for emergency authorization.
"Today's action will dramatically expand access to this treatment," Trump said. "This is the only possible and it's only made possible because of Operation: Warp Speed, that is everybody working together. We're years ahead of approvals than we would be if we went by speed levels of past administrations. We'd be two years, three years behind where we are today.
"We're removing unnecessary barriers and delays, not by cutting corners, but by marshaling the full power of the federal government," Trump added.
"This is kind of a ... it's a gap measure that allows us to treat these patients and fight off the disease until a drug is actually created and found to be effective," said Dr. Lawrence Fialkow, medical director of the Greater New York Region of the Red Cross.
The Red Cross has been working with the FDA since April, creating guidelines for and collecting plasma donations.
"Ideally, it's going to allow broader access for patients. The theoretical risks are that we're still collecting data so we still don't 100% know how effective or partially effective or ineffective this product is in certain patients, earlier in treatment, later in treatment. We're still answering those questions," Fialkow said.
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The FDA and the Red Cross are still asking those who have recovered from the virus to donate their blood plasma.
Avrohom Weinstein of Lakewood, N.J. told Bauman he feels grateful to have recovered from COVID-19, and is now donating his blood plasma to be used as treatment for those still fighting the virus.
"We tested the whole family. I had high antibodies, so they called me to donate and I don't see why I shouldn't," Weinstein said.
In March, the FDA created a pathway for scientists to try convalescent plasma with patients and study its impact and so far more than 70,000 people in the U.S. have been treated.
The FDA said it has a 35% improvement in survival.
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