FDA OKs convalescent plasma as COVID–19 treatment
WASHINGTON – On Aug. 23, the U.S. Food and Drug Administration issued an emergency use authorization for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19.
According to a FDA release, based on scientific evidence available, the FDA concluded that convalescent plasma may be effective in treating COVID-19 and that the known and potential benefits outweigh the known and potential risks.
The release states the EUA follows the FDA’s review of science and data generated during the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to demonstrate safety and efficacy remain ongoing.
“The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19,” the release states.
FDA Commissioner Stephen M. Hahn said the FDA is committed to releasing safe and potentially helpful COVID-19 treatments to save lives.
“We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” he said. “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.”
Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.
“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 release states. “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.”