President Donald Trump said Sunday that U.S. regulators have given an emergency approval for a coronavirus treatment involving blood plasma donated by people who have recovered from the disease.
The approval comes after the FDA at first made a decision against allowing blood plasma at the request of the top wellbeing officers who referred to deficient proof.
“This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” Trump told reporters at a White House news briefing. “We’re removing unnecessary barriers and delays, not by cutting corners, but by marshaling the full power of the federal government.”
The authorization allows for the distribution of COVID-19 convalescent plasma in the U.S. and for health care providers to administer it as appropriate to treat patients hospitalized with suspected or confirmed COVID-19.
Stephen Hahn, commissioner of the Food and Drug Administration, said Sunday that he is “committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives.”
“In the independent judgment of experts and expert scientists at the FDA ― who have reviewed the totality of data, not just the data from this expanded access program, but more than a dozen published studies, as well as the historical experience associated with this ― those scientists have concluded that COVID-19 convalescent plasma is safe, ensures promising efficacy, thereby meeting the criteria for emergency use authorization,” Hahn said at the conference.
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. https://t.co/sxWrblWsxr pic.twitter.com/DnTrJaDTX1
— U.S. FDA (@US_FDA) August 23, 2020
The approval comes after the FDA put the recovered plasma endorsement on hold in light of worries from top federal wellbeing authorities, including Dr. Francis Collins and Dr. Anthony Fauci, The New York Times revealed two week ago.
In spite of the fact that blood plasma donated from recuperated COVID-19 patients is viewed as protected, top researchers said the clinical preliminaries have not yet demonstrated whether it is effective enough for treating the infection brought about by the coronavirus. The FDA had intended to give emergency use approval for the treatment at the beginning of the current month but decided against it after wellbeing specialists contended there was inadequate proof.
“The trial that that’s going to be based on ― 70,000 patients ― wasn’t a very rigorously done trial. It was an open-label study where everyone got treated, so it’s hard to draw conclusions,” former FDA Commissioner Scott Gottlieb told CBS’s “Face the Nation” on Sunday.
“I believe plasma is probably beneficial. It’s probably weakly beneficial in the setting of this treatment,” he continued. “But I think some people wanted to see more rigorous data to ground that decision.”
.@realDonaldTrump has suggested new "breakthroughs" on the #COVID19 therapeutic front. @scottgottliebMD tells @margbrennan that it is likely related to an emergency use authorization to allow more commercial distribution for plasma for #COVID19 patients. pic.twitter.com/8xL5K6hDhz
— Face The Nation (@FaceTheNation) August 23, 2020
Trump said the federal government gave $48 million to finance a Mayo Clinic study that worked on the adequacy of recovering plasma for COVID-19 patients.
The investigation indicated that the plasma diminished mortality by 35% among 100,000 members getting the treatment, as per Hahn and Alex Azar, secretary of health and human services.
“There was a 35% improvement in survival, which is a significant clinical benefit,” Hahn said of the study. “Now we’re waiting for more data — 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.”
Trump on Saturday blamed FDA representatives for purposefully deferring progress on a COVID-19 immunization and treatment since they were out to hurt the president’s chances in the election, without offering any proof to validate the assertion.
The president’s conspiracy-oaded tweet seemed to blame the FDA for meddling with drugs company enrollment of subjects for testing vaccines and effective therapies in the fight against the infection.
House Speaker Nancy Pelosi (D-Calif.) called Trump’s “deep state” allegation “very scary” and “beyond the pale in terms of how he would jeopardize the health and well-being of the American people.”
The FDA must approve drugs or vaccines based on their safety and effectiveness – NOT political pressure from the White House.
The President’s dangerous attempt to inject himself into the scientific decisions of @US_FDA jeopardizes the health & well-being of all Americans. https://t.co/Dt7CBVjX1D
— Nancy Pelosi (@SpeakerPelosi) August 22, 2020
“The FDA has a responsibility to approve drugs, judging on their safety and their efficacy ― not by a declaration from the White House about speed and politicizing the FDA,” Pelosi said Saturday at a Washington news briefing.
Trump repeated a portion of his initial thoughts when questioned at Sunday’s briefing if the emergency use authorization was political in nature.
“Well, I think that there might have been a holdup, but we broke the logjam over the last week,” Trump said. “To be honest, I think that there are people in the FDA and actually in your larger department that can see things being held up and wouldn’t mind so much, it’s my opinion, a very strong opinion, and that’s for political reasons.”
The FDA said Sunday that the “known and potential benefits” of plasma treatment on coronavirus patients “outweigh the known and potential risks” and that there are “no adequate, approved and available alternative treatments.”
Hahn declined to respond to the questions Sunday regarding whether he was forced to give an emergency use approval for healing plasma treatment before it was prepared.
The pandemic keeps on attacking the U.S., with about 5.7 million coronavirus cases and 176,645 passings as of Sunday evening, as per Johns Hopkins University.
