President Donald Trump announced a " major therapeutic breakthrough " regarding COVID-19 on Sunday. The president heralded the ...
President Donald Trump announced a "major therapeutic breakthrough" regarding COVID-19 on Sunday. The president heralded the emergency authorization for convalescent plasma therapy as a coronavirus treatment that is "very effective."
"Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives," Trump said at a White House press briefing. "Today's action will dramatically increase access to this treatment."
"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 U.S. Food and Drug Administration issued an emergency use authorization for the use of convalescent plasma as a COVID-19 treatment. Convalescent plasma therapy was greenlit by the FDA based on preliminary data, but is still undergoing testing.
FDA Commissioner Stephen Hahn said convalescent plasma reduced the COVID-19 morality rate by 35% in early findings.
"I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives," Hahn said. "We're encouraged by the early promising data that we've seen about convalescent plasma."
"The FDA's emergency authorization for convalescent plasma is a milestone achievement in President Trump's efforts to save lives from COVID-19," Health and Human Services Secretary Alex Azar said. "The Trump Administration recognized the potential of convalescent plasma early on."
"We dream in drug development of something like a 35% mortality reduction," Azar said. "This is a major advance in the treatment of patients."
The FDA said convalescent plasma "may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product."
Over 70,000 U.S. patients have been given convalescent plasma as part of an expanded access program from the FDA and the Mayo Clinic, officials told the Washington Post.
Mayo Clinic researchers and collaborators found convalescent plasma "to be safe following transfusion in a diverse group of 20,000 patients."
Convalescent plasma is blood plasma extracted from a human patient who has recovered from a disease and given to a patient who is battling the same disease.
Convalescent plasma provides passive immunity, which means that the body doesn't create its own antibodies. Instead, the body borrows the antibodies from the plasma of the patient who fought off the disease. Convalescent plasma is different than a vaccine, which is active immunity, because the borrowed antibodies don't last a lifetime, but can be a lifesaving treatment.
"Convalescent plasma has been used throughout history when confronting an infectious disease where you have people who recover and there's no other therapy available," according to Warner Greene, director of the Center for HIV Cure Research at the Gladstone Institutes. "There must be something in their plasma—i.e. an antibody—that helped them recover."
Convalescent plasma has been used for over a century, and cut the fatality rate in half during the Spanish flu, also known as the 1918 influenza pandemic. It was also effective against polio before there was a vaccine. However, it was not successful against Ebola.
There are nearly 5.7 million confirmed cases of COVID-19 in the United States.
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