The US Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for Covid-19 convalescent plasma on Thursday, limiting use to convalescent plasma with high antibody levels, and in hospitalized patients early in their disease course.
Convalescent plasma is used to treat Covid-19, and is made using the blood of people who have recovered from coronavirus infections. It was first approved for emergency use authorization last August.
Under the revised EUA, the treatment can also be used for those with impaired immunity that has left them unable to produce an adequate antibody response.
The updates were informed by new clinical trial data, made available after August 2020.
Convalescent plasma that is not rich in antibodies has not been shown to be helpful in treating Covid-19 and is no longer authorized for emergency use, the FDA said.
“COVID-19 convalescent plasma used according to the revised EUA may have efficacy and its known and potential benefits outweigh its known and potential risks,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The EUA was also updated Thursday to allow for additional tests to be used in the manufacture of Covid-19 convalescent plasma.