Aug. 24, 2020
The FDA on Sunday issued an emergency use authorization (EUA) for convalescent plasma to treat patients with COVID-19. The new EUA expands access to the treatment, which the FDA said may be effective in treating COVID-19 and “known and potential benefits of the product outweigh the known and potential risks.”
The EUA allows healthcare providers across the U.S. access to plasma from COVID-19 patients who’ve recovered. It also requires the FDA to inform healthcare providers and patients about the treatment option, dosing instructions and possible side effects, which include transfusion-associated circulatory overload, transfusion-associated lung injury and transfusion-transmitted infections.
Factors cited for EUA approval were:
- Prior use of plasma in prior outbreaks of respiratory viruses;
- Preclinical evidence;
- Results from small clinical trials during the pandemic; and
- Data from the National Expanded Access Treatment Protocol sponsored by the Mayo Clinic.
The Mayo Clinic’s preliminary data show fewer deaths among the 35,000 patients given the antibody-rich plasma within three days of diagnosis and given plasma with the highest antibody levels. Patients who were treated with plasma containing the highest antibody levels had a 35% lower risk of dying within a week compared to those treated with less-rich plasma. The results were not from a formal study.
FDA Commissioner Stephen Hahn, M.D., said: “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus. At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”