TAMPA, Fla. -- The U.S. has taken a major step forward in the fight against COVID-19.
The Food and Drug Administration (FDA) has given convalescent plasma emergency use authorization, or EUA, for use on sick patients. Tampa Bay area doctors are explaining how the EUA works, the promising results they are seeing and the limitations.
Even more coronavirus-fighting plasma is coming to hospitals near you with the FDA's latest EUA.
“It’s about time," said Dr. Charles Lockwood, Senior Vice President at the University of South Florida Health. "I think there's enough experience with convalescent plasma, a hundred years of experience."
Dr. Lockwood has been using the plasma of recovered COVID-19 patients to help the ones still sick at Tampa General Hospital since April.
“It definitely reduces mortality. It reduces requirements for oxygen, the length of ventilation, the length of time in the hospital," he said.
While several studies report promising improvements for COVID-19 patients, there is not yet randomized clinical trial data. Despite that, Lockwood insists this is no Hydroxychloroquine.
“I think we’re in pretty solid scientific ground for the FDA to have made this decision," he said.
Another big question is what this temporary authorization means for Tampa Bay area doctors and the patients under their care.
“What it means is less paperwork, faster delivery of the drug to patients," said Dr. Lockwood. "I think it will speed up the process, probably save us a day and that day may save lives.”
Lockwood explained that before, the EUA doctors would have to go through a cumbersome process of completing an investigational new drug application with the FDA. This EUA now empowers doctors to apply the treatment without jumping through hoops.
Lockwood says that while the EUA was the right move to save lives now it could have other unintended consequences. He believes it could lower enrollment into the official randomized clinical trials. Lockwood says with the publicity of convalescent plasma, COVID-19 patients may be less likely to partake in a study that could mean they end up with the placebo.
Susan Forbes, Senior Vice President of Corporate Communications with OneBlood, says over the past month, they’ve had a 500 percent increase in hospital orders for convalescent plasma. She attributes the spike to increases in COVID-19 cases and doctors using convalescent plasma earlier when treating patients. She expects demand will now shoot up even more with FDA's move.
“Expanded access means more people are going to get it. We need more people to give it and that is the bottom line. It’s not only a need right now, it is a need for the long haul," she said.
Another serious serious barrier to this treatment is the limited supply. That’s why Forbes is urging those who have recovered from COVID-19 to donate blood every 28 days.
“Our motto in medicine is ‘premium non nocere’ first do no harm. I think on balance this is a case where we are doing no harm," said Lockwood.
Lockwood believes this convalescent plasma is no silver bullet but he's hopeful this treatment combined with other promising drugs like Remdesivir, and better usage of ventilators can mean more people have a fighting chance.