Trump Issues Emergency Approval for 'Major Breakthrough' Coronavirus Treatment
President Donald Trump on Sunday night issued what he called “a truly historic announcement in our battle against the China virus that will save countless lives.”
During a special White House briefing, Trump said the federal Food and Drug Administration has issued an emergency use authorization allowing convalescent plasma to be used as a treatment for COVID-19.
Convalescent plasma treatment injects individuals with antibodies from the blood of recovered patients to help treat those who have been infected battle the disease — in essence, sending reinforcements to a patient’s immunity system.
Trump said Sunday that a Mayo Clinic study of 100,000 Americans found that treatment with convalescent plasma can cut mortality by 35 percent.
He also said the FDA itself, as well as the Massachusetts Institute of Technology and Mount Sinai hospital in New York City, had found that convalescent plasma works.
“Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective,” Trump said.
The president said the millions of Americans who have recovered from a brush with the coronavirus can help those now facing it.
“I once again urge all Americans who have recovered from the virus to go to Coronavirus.gov and sign up and donate plasma today please. It’s been really an incredible — just incredible people. The country has united so strongly behind this,” he said.
Trump said the success of the new treatment builds upon previous successful efforts to fight the virus.
During his briefing, he noted that “the European Union’s case-fatality rate is estimated to be three times higher than that in the United States. Europe has seen 33 percent more fatalities, compared to a typical non-pandemic year, than the United States.”
Health and Human Services Secretary Alex Azar said patients treated within three days of being diagnosed as having the virus had the most benefits from convalescent plasma.
“We saw about a 35 percent better survival in the patients who benefited most from the treatment — which were patients under 80 who were not on artificial respiration,” he said. “I just want to emphasize this point because I don’t want you to gloss over this number. We dream, in drug development, of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance.”
Dr. Stephen Hahn, director of the FDA, said the use of convalescent plasma followed longstanding medical practices and the FDA acted after a thorough review of all existing studies and literature.
The EUA authorizes the distribution of #COVID19 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.
— U.S. FDA (@US_FDA) August 23, 2020
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.
— U.S. FDA (@US_FDA) August 23, 2020
During the briefing, Trump restated his contention that within the FDA there is opposition to moving as fast as the administration is moving to fight COVD-19. The president last week had publicly scolded elements with the FDA he said were working against him.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
“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,” he said. “That’s my opinion — a very strong opinion. And that’s for political reasons.
“This has nothing to do with politics; this has to do with life and death. So we are being very strong, and we are being very forthright, and we have got some incredible answers. And we’re not going to let them be held up because every day is lives. And we’re not going to let that happen. OK?”
White House Chief of Staff Mark Meadows had said earlier Sunday that Trump had been impatient with the process of approving convalescent plasma as a treatment, according to ABC News.
“This president is about cutting red tape. That’s what the tweet was all about,” Meadows said.
“He had to make sure that they felt the heat. If they don’t see the light, they need to feel the heat because the American people are suffering, this president knows it, and he’s going to put it on wherever — the FDA or NIH or anybody else to make sure that we deliver on behalf of the American people,” he said.
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