Vaccine in Doctors Hands

FDA Gives Emergency Authorization For Covid-19 Plasma Treatment

The US Food and Drug Administration (FDA) last week issued an Emergency Use Authorization (EUA) to allow doctors and hospitals across the country to treat Covid-19 patients with convalescent plasma. 70,000 patients have already been treated via this method and the FDA say that the “known and potential benefits of the product outweigh the known and potential risks of the product.”

President Trump could be heard last week accusing FDA health officials of ‘playing politics’ when it came to the decision of issuing an emergency use authorization for convalescent plasma. The FDA say they reviewed additional data before making the new decision on the EUA.

“Today, I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives. The FDA has issued an Emergency Use Authorization, and that’s such a powerful term, Emergency Use Authorization, for a treatment known as convalescent plasma,” President Donald Trump said during his latest coronavirus press conference. “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. It’s had an incredible rate of success. Today’s action will dramatically expand access to this treatment. “To deliver treatments and vaccines to save lives, we’re removing unnecessary barriers and delays, not by cutting corners, but by marshaling the full power of the federal government,” Trump continued.

 

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“We provided $48 million to fund the Mayo Clinic study that tested the efficacy of convalescent plasma for patients with the virus. Through this study over 100,000 Americans have already enrolled to receive this treatment, and it is proven to reduce mortality by 35%. It’s a tremendous number.” Convalescent plasma has to be donated from people who have had and recovered from Covid-19, as it is taken from their blood. The FDA attempted to fast track the pathway for scientists to study the impact and effects of convalescent plasma at the end of March, with approximately 70,000 Covid-19 patients having been treated via the method so far.

“The FDA, MIT, Harvard, and Mount Sinai Hospital have also found convalescent plasma to be a very effective method of fighting this horrible disease,” Trump added during the press conference.
“Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective. “Recently, we provided up to $270 million to the American Red Cross and America’s blood centers to support the collection of up to 360,000 units of plasma. In late July, we launched a nationwide campaign to ask patients who have recovered, and these are patients that have been incredible the way they’ve donated.”

Unfortunately, like blood, convalescent plasma can only be provided by donors and is in extremely limited supply. Studies conducted in the US into the efficacy of the treatment in treating Covid-19 have been positive so far, but worries have arisen from some healthcare experts about the lack of randomized clinical trial data. These trials are being conducted currently. “But these are people recovered from the virus to donate plasma. Since then, weekly plasma donations have doubled. Today, 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,” said Trump.

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“I just want to ask two of our people that have done such a fantastic job, Alex Azar and Stephen Hahn to say a few words. Stephen, I want to thank you because the FDA really stepped up and especially over the last few days in getting this done. The results have been incredible, and I think you’ll see the results even go up very substantially. So we appreciate it.” A national study of 35,000 patients treated with convalescent plasma found that 8.7% of patients treated within three days of diagnosis died, while the figure was 12% for those treated four days or more after their initial diagnosis.

It was also found during the trial that patients treated with the plasma that contained the highest levels of antibodies had an approximately 35% lower risk of dying within seven days, compared to those treated with plasma that was less rich. “The data we gathered suggests that patients who were treated early in their disease course, within three days of being diagnosed, with plasma containing high levels of antibodies, benefited the most from treatment. We saw about a 35% better survival in the patients who benefited most from the treatment,” US Health and Human Services Secretary Alex Azar said, also present at Trump’s coronavirus press conference.

“We dream in drug development of something like a 35% mortality reduction. This is a major advance in the treatment of patients. A major advance.”

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