The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) allowing the use of human plasma collected from individuals whose plasma contains antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the treatment of patients hospitalized with coronavirus disease 2019 (COVID-19).
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.
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).
“We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” said FDA Commissioner Stephen M. Hahn, MD. “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.” In a press statement, Hahn acknowledged that additional randomized clinical trials were needed to provide definitive evidence of safety and efficacy.
Potential side effects of COVID-19 convalescent plasma treatment may include transfusion-transmitted infections, allergic reactions, transfusion-related acute lung injury and transfusion-associated cardiac overload. However, based on current data, the FDA has determined that “the known and potential benefits of COVID-19 convalescent plasma outweigh the known and potential risks.”
As part of the EUA, a fact sheet has been created to inform healthcare providers on the potential risks and benefits of the emergency use of COVID-19 convalescent plasma. The fact sheet also includes dosage and administration information, as well as recommendations related to use in the treatment of specific populations (ie, children, elderly, pregnant and nursing women).
For more information visit fda.gov.
FDA issues emergency use authorization for convalescent plasma as potential promising COVID–19 treatment, another achievement in Administration’s fight against pandemic. https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment. Accessed August 24, 2020.