On Sunday, President Trump announced that the Food and Drug Administration (FDA) has approved the use of convalescent plasma in COVID-19 patients. The FDA approved the plasma product as an emergency use for novel coronavirus patients.
The president called the news a “historic breakthrough” and said the emergency approval of convalescent plasma would “dramatically expand access to this treatment.”
Convalescent plasma is made from the blood of patients who have already recovered from the novel coronavirus. It has previously been used to treat other viral infections, such as SARS, Ebola, and MERS. In addition, 70,000 Americans have been treated with convalescent plasma during the current coronavirus crisis.
Many experts have expressed optimism about the treatment. Stephen Hahn, Commissioner of the FDA, said, “We’re encouraged by the early promising data that we’ve seen about convalescent plasma. 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.”
Hahn said his agency is working with researchers to continue to study the effectiveness and safety of convalescent plasma in COVID-19 patients. Meanwhile, Hahn says that data shows that those who have already been treated with the plasma have a 35 percent higher survival rate.
Some medical experts are concerned that the wide availability of the plasma prevents a full understanding of the accuracy of how well it works in randomized trials. There have already been challenges in recruiting volunteers for the clinical trials because patients have already received treatment outside a trial.
“Optimism isn’t science,” Dr. Ashish Jha tweeted. Jha is the Harvard Global Health Institute’s director, and while Jha has been optimistic about the therapeutic uses of plasma, he’s apprehensive. “We need results of adequately powered randomized trials. Issuing an EUA without it would make such trials harder. And erode the credibility of the FDA.”
Former FDA Commissioner Scott Gottlieb said the emergency use authorization will allow easier access in some settings. “What the emergency use authorization will allow is probably more commercial distribution, and it will allow manufacturers or plasma products to more easily recoup the costs,” said Gottlieb. “The bottom line is it’s widely available right now. Patients are getting it. It’s incremental, and incremental gains are important here, but we need to view it for what it is.”