WASHINGTON- The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Sunday for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients.
It is part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded 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, said a release of the agency.
The EUA authorizes the distribution of COVID-19 convalescent plasma in the United States and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19, said the FDA.
“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,” said FDA Commissioner Stephen Hahn.
“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,” he added.
“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said U.S. Health and Human Services Secretary Alex Azar.
Months ago, the FDA, together with the U.S. Biomedical Advanced Research and Development Authority and private partners, began work on making this product available across the country while continuing to evaluate data through clinical trials, Azar said.
Convalescent plasma has been used to treat more than 70,000 American COVID-19 patients so far, according to Azar.
Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus.
Prior experience with respiratory viruses and limited data from other countries suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19.
The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma, said the FDA.