The Food and Drug Administration authorized the emergency use of blood plasma from COVID-19 survivors as a treatment for sick patients. The announcement came after President Donald Trump publicly pressured the agency to speed the development of drugs and vaccines.
Plasma should not be the new standard of care for COVID-19, the agency said in a statement. However, it may shorten or reduce the severity of the illness in hospitalized patients. “We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” said commissioner Stephen Hahn in the statement.
Preliminary research suggests that the plasma, which contains antibodies against the coronavirus, could help improve the survival rate of people hospitalized with the disease. However, the treatment has only been tested in small groups of COVID-19 patients, and not in the large, placebo-controlled clinical trials that could give clear answers.
The agency noted that the evidence supporting the decision to authorize plasma did not come from gold-standard randomized clinical trials in its fact sheet about convalescent plasma for health care workers. “Facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma,” the FDA said in its statement.
The FDA had plans to issue an emergency authorization for plasma at the start of August, but put those plans on hold after health officials raised concerns there was not strong enough data supporting the treatment, according to The New York Times. Data from a large study of plasma found that patients had a lower death rate if they received plasma within three days of their diagnosis than if they received it later, but those patients were not compared to a placebo group. Officials decided to scrutinize the data more closely.
In a press conference last week, President Donald Trump said without evidence that the delay was politically motivated. “People are dying, and we should have it approved if it’s good,” he said. He then accused the FDA of stalling the development of COVID-19 drugs and vaccines on Twitter.
Given the explicitly political pressure on the FDA to rush the approval of COVID-19 products, authorizing a new product 1) without publishing the evidence and 2) without a supporting randomized trial risks further damage to public trust in the agency. https://t.co/0lKJqyrR5R
— Rachel Sachs (@RESachs) August 23, 2020
Emergency authorization is not full FDA approval, but it indicates that the agency believes the benefits of the therapy outweigh the risks. One other treatment, the antiviral drug remdesivir, is authorized to treat COVID-19.
Convalescent plasma is an old-school approach to treating infectious disease; it’s been used since the 1890s to treat diphtheria, pandemic flu, and chickenpox.
“With plasma we’re leveraging the body’s amazing ability to develop antibodies and immunity to pathogens,” Elliott Bennett-Guerrero, who is studying the use of this convalescent plasma in COVID-19 patients at Stony Brook Medicine, told The Verge in April. “We transfer those protective factors to people who are sick and haven’t been able to mount an immune response.”
Thousands of COVID-19 patients in the US have already been treated with plasma through clinical trials and emergency access programs. The FDA has been helping coordinate those efforts since March. The new authorization, though, would knock down some logistical barriers and make it easier for patients to access the treatment.
Clinical trials on plasma as a treatment for COVID-19 are still ongoing. Scientists are also studying if infusions of the plasma could protect healthy people who are at high risk for contracting the virus, like health care workers, from getting sick.
The US Department of Health and Human Services is encouraging people who have recovered from COVID-19 to donate plasma through a series of PSAs, and the FDA has a website directing people to donation sites.
Update August 23, 5:46 PM ET: Updated with information from the FDA.