The agency limited it Emergency Use Authorization (EUA) for the COVID-19 therapy to the use of high titer COVID-19 convalescent plasma only for the treatment of hospitalized patients early in the disease. FDA is no longer authorizing the use of low-titer plasma in its EUA due to a lack of efficaciousness in further studies.
The US Food and Drug Administration (FDA) announced yesterday it had modified its EUA for convalescent plasma to limit the authorization to the use of high titer plasma only for the treatment of hospitalized patients early in the disease state.
“Issuance of, and updates to, EUAs are based on a thorough evaluation of currently available scientific evidence about medical products,” the FDA wrote on its site. “In this case, as additional scientific evidence about COVID-19 convalescent plasma emerged, we revised the EUA to reflect the updated evidence. 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.”
In making the announcement, the federal agency no longer authorized, as part of its EUA, the use of low titer COVID-19 convalescent plasma as further data and trials, “have not shown evidence to demonstrate that low titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19.”
In addition, the FDA also said that for “hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response. plasma with low levels of antibodies has not been shown to be helpful in COVID-19.”
Convalescent plasma received an EUA last August after some debate showing conflicting data about its effectiveness at that point in time.
In August, the FDA said it based the EUA on the available data indicating convalescent plasma may be beneficial for treatment of COVID-19, and that the known and potential product benefits outweigh its understood risks.
“Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing,” the FDA stated then.