The Food and Drug Administration is scaling back the authorization to use recovery plasma for Covid-19 patients in an effort to guide doctors who have a confusing bunch of information about the effectiveness of therapy.
The agency said late Thursday that the authorization, subject to controversy since its issuance last year in August, would be reviewed to limit the use of plasma early in the course of the disease to patients in the hospital, and patients with a medical condition affecting their ability to make antibodies. Patients should only receive plasma containing high concentrations of antibodies.
“The update is intended to make the best use of recovery plasmas for those who benefit from it,” said Peter Marks, director of the FDA’s center for biological evaluation and research. “It’s used a little more indiscriminately.”
Dr. Claudia Cohn, chief medical officer of AABB, an organization representing the transfusion medicine community, said the group plans to issue interim recommendations on recovery plasma later this month. “There are so many studies with different conclusions,” she said. “It’s not clean, it’s not black and white.”
Dr Marks said the FDA came to its decision after evaluating the results of several recent studies. Some have shown benefits through recovery plasma, the antibody-containing fluid from the blood of people who have recovered from Covid-19. Others showed no benefit.
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Two clinical trials of recovery plasma for patients admitted to hospital were discontinued last month after investigators said there appeared to be no benefit. In three trials involving patients admitted to hospital, there was a recent benefit to plasma, but it was only administered to patients shortly after admission. Another trial showed that older patients were less likely to develop serious illness shortly after symptoms appeared.
Arturo Casadevall, chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, calls the FDA decision a step forward. He said: “For the first time, doctors in the US are going to have guidance on when to use it and how to use ” recovery plasma ‘.
Dr. Casadevall is a co-founder of the Covid-19 Convalescent Plasma Project, which helped organize a nationwide study with extensive access to recovery plasma that began last April.
Despite conflicting findings, there is still a demand for recovery problems – in part because there are few effective treatments for Covid-19 and many people have not been vaccinated. Since the FDA issued the emergency permit in August last year, the blood industry has distributed an average of 20,600 units of recovery plasma per week to hospitals, according to the American Red Cross.
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The FDA’s earlier decision to authorize recovery plasma for in-hospital Covid-19 patients was largely based on the results of an agency-wide extended access program sponsoring more than 72,000 patients. has. For a study published in the New England Journal of Medicine last month, researchers analyzed data from 3,000 of the patients and reported an apparent survival benefit among hospitalized patients who were not on mechanical ventilation, who received plasma at high concentrations contains antibodies.
But many scientists have expressed skepticism about the finding, saying extended-access studies do not have the scientific accuracy of traditional trials because they have no control group to compare any apparent effect.
According to the FDA, dr. Marks, the approval of recovery plasma could be handled much better. It has to do with the sense of urgency that everyone feels. I can not blame anyone for having a sense of urgency. ‘
Dr Marks also said the data could be confusing. Each unit of recovery plasma is unique, reflecting the immune response of the patient who donated it. It took time to figure out the best way to measure the antibodies in a unit, he added.
The US is not the only government that wants to draw up reliable guidelines for the use of recovery plasma. In Argentina, a study among elderly outpatients published in the New England Journal of Medicine last month contributed to current recommendations to treat elderly Covid-19 patients early in the course of their disease. “Plasma supply is not endless, and public health officials are constantly faced with difficult decisions,” said co-author of the study, Dr. Fernando Polack, of Fundación Infant in Buenos Aires said. “In any of these decisions, data-based guidelines are needed and are the best way for clinicians to feel comfortable when facing individual cases.”
Donors donating blood and plasma at a donation center in Brooklyn, NY
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Natalie Keyssar for The Wall Street Journal
Louis M. Katz, chief medical officer of the Mississippi Valley Regional Blood Center in Davenport, Iowa, which supplies blood products to more than 120 hospitals, said the evidence showing the use of recovery plasma in patients admitted to the hospital is weak. “I think the data is there that it works early,” he said. “As you move in with sicker and sicker people, the evidence gets thinner and thinner.”
In an editorial co-authored with the New England Journal of Medicine article on the American study with extended access, dr. Katz said recovery plasma should only be used in patients early in the course of the disease. The problem with the proposal, he later added, is that FDA emergency authorizations are still only admitted to the hospital, which tends to show up in the hospital if they have been ill for longer.
The treatment of Covid-19 patients who are just beginning to show symptoms presents its own challenges. “Logistically, it is very difficult to treat patients earlier,” said Dr. Katz said. “It’s difficult to deliver a lot of plasma to outpatients.”
Dr Marks said a major National Institutes of Health study is now underway to test plasma in people with Covid-19 who are sick enough to come to the emergency room but who are not hospitalized. as well as other randomized controlled trials. plasma in outpatients. “Until we have the data, we will keep the consent for patients in the hospital,” he said. “We will refine it again if appropriate. It is a scarce resource. ”
Write to Amy Dockser Marcus by [email protected]
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