The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients.

Evidence:

Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

The EUA was issued based on historical evidence indicating some effectiveness with convalescent plasma in previous outbreaks of respiratory viruses, as well as preclinical data, results from small clinical trials during the COVID-19 pandemic, and data from the National Expanded Access Treatment Protocol sponsored by the Mayo Clinic. 

With the Mayo Clinic facilitating various study sites, over 70,000 patients have already been treated with convalescent plasma in 2020.

According to the Agency, the totality of available evidence suggests that COVID-19 convalescent plasma with high antibody titers may potentially reduce death in hospitalized COVID-19 patients, especially if treatment is administered early in the course of the disease. Results posted on the FDA website demonstrate a statistically significant 37% reduction in mortality at 7 days in non-intubated patients (age ≤80 years; n=1018) treated with high titer convalescent plasma within 72 hours (P =.03).

Terms of EUA

The EUA requires that fact sheets providing important information about using COVID-19 convalescent plasma in treating COVID-19 be made available to health care providers and patients, including dosing instructions and potential side effects. Possible side effects of COVID-19 convalescent plasma include allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.

The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.

Source:

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment.