FDA Gives Convalescent Plasma Emergency Approval For COVID-19 Treatment

Aug 25, 2020, 4:30 PM

SALT LAKE CITY, Utah – The U.S. Food and Drug Administration has authorized the use of convalescent plasma as a treatment for COVID-19, and one Utah woman said the treatment saved her life.

The FDA gave emergency authorization for the plasma treatments this week, and there is a push for people who have recovered from COVID-19 to donate plasma in Utah.

“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” said FDA Commissioner Dr. Stephen M. Hahn. “The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus.”

Magna resident Cynthia Lemus said the plasma treatment changed everything for her.

Just weeks into the start of the pandemic, Lemus and her husband, Moses, noticed symptoms of the disease.

After days of staying home, they knew it was time to go to the emergency room. Moses was sent home, while Cynthia remained at the hospital.

“I just told her I loved and she was going to be OK and she was going to be fine. And that’s when our whole journey started,” he said.

The journey would include over three weeks of separation as Cynthia fought the virus in the hospital, spending 20 days on a ventilator.

“When Cynthia was extremely sick, we literally had no hope,” Moses said.

That changed when doctors at Intermountain Healthcare recommended a plasma transfusion. Thirteen days later, Cynthia was finally heading home.

“It’s just all thank you to you guys that I’m here,” she said.

She was among the first of more than 500 Utah patients to receive convalescent plasma as a treatment, and one of roughly 70,000 across the country.

Dr. Brandon Webb with Intermountain Healthcare explained, “Treatments may benefit the patients themselves but also benefit society, as we learn what works best.”

Plasma from recovered patients has not been clinically proven to treat the infected. However, the FDA has now given emergency authorization to use it, saying the potential benefits outweigh the potential risks.

“This is a new disease. And we’re still very much needing to learn the best way to treat this disease,” Webb said.

The emergency authorization means any hospital can use the plasma as a treatment. There is already a national shortage and expanding access will make it harder to get.

Moses Lemus doesn’t know what would have happened had his wife not received the plasma. He has already donated his own and only hopes it can do for someone else what he believes it did for her.

“She’s here with us now and she’s able to live a life that was almost taken from us,” he said.

Many doctors said more data is needed from randomized, placebo-controlled clinical trials to determine how the plasma is affecting the patient.

Those trials are underway.

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FDA Gives Convalescent Plasma Emergency Approval For COVID-19 Treatment