February 4, 2021
The following quote is attributed to Peter Marks, M.D., Ph.D., Director of FDA’s Center for Biologics Evaluation and Research:
“The FDA is issuing a revision of the Emergency Use Authorization (EUA) for COVID-19 convalescent plasma as a result of our evaluation of the most recent information available. Based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020, we have revised the EUA to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients early in the disease course. This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients.
“Issuance of, and updates to, EUAs are based on a thorough evaluation of currently available scientific evidence about medical products. 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.”
- Today, the FDA is revising the Letter of Authorization for COVID-19 convalescent plasma to limit the authorization to the use of high titer COVID-19 convalescent plasma only for the treatment of hospitalized patients with COVID-19 early in the disease course and to those 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.
- The use of low titer COVID-19 convalescent plasma is no longer authorized under the EUA as additional data from clinical trials, including randomized, controlled trials, have not shown evidence to demonstrate that low titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19.
- On Aug. 23, 2020, the FDA issued an EUA for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients. The FDA based its decision on the available scientific evidence and concluded that the known and potential benefits of the product outweighed its known and potential risks.
- On Nov. 30, 2020, the FDA reissued the Letter of Authorization for the EUA to include an additional test to be used in the manufacture of COVID-19 convalescent plasma.
- The Fact Sheet for Health Care Providers has been updated to note, among other things, that transfusion of COVID-19 convalescent plasma in hospitalized patients late in the course of illness (e.g. following respiratory failure requiring intubation and mechanical ventilation) has not been associated with clinical benefit.
- The EUA has also been updated to include several additional tests to be used in the manufacture of COVID-19 convalescent plasma. With this update, nine tests are now included in the EUA for testing plasma donations for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.