WASHINGTON — The FDA reversed its stance on convalescent plasma, and on Sunday, Aug. 23, issued an emergency use authorization (EUA) for the use of convalescent plasma in the treatment of Covid-19.
A few days earlier, BreakingMED reported that the agency has decided to halt issuing the EUA after several prominent infectious disease specialists, including Anthony Fauci, MD, National Institute of Allergy and Infectious Diseases (NIAID), said the data were not there to give it the nod. They based their recommendation on a not-yet-peer reviewed trial from the Mayo Clinic.
Nonetheless, the FDA decided to move ahead with the EUA, noting in a media release that “the known and potential benefits of the product outweigh the known and potential risks of the product.” They noted that their recommendation is based on the “extensive review of the science and data generated over the past several months.”
“I am committed to releasing safe and potentially helpful treatments for Covid-19 as quickly as possible in order to save lives,” Stephen M. Hahn, MD, FDA Commissioner, said in the statement. “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.”
In its decision memorandum, the FDA outlined the research that spurred its decision and also noted that the Covid-19 convalescent plasma (CCP) has to be “collected by FDA registered blood establishments and from individuals whose plasma contains anti-SARS-CoV-2 antibodies.” The agency also added that its use is for suspected or confirmed Covid-19 in hospitalized patients.
Shortly after the FDA’s announcement, President Donald J. Trump held a news conference and touted the treatment as a “powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help patients currently battling a current infection” and urged people to donate convalescent plasma. He thanked the FDA — particularly Hahn — and HHS director Alex Azar for “stepping up to get the job done.”
During the news conference, Hahn said that, in reviewing all the data, they found that the use of convalescent plasma yields at 35% improvement in survival, which he noted is significant.
Along with President Trump, Hahn and Azar urged people who have recovered from Covid-19 to donate convalescent plasma.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 151
Topic ID: 88,151,254,930,791,932,190,926,192,927,151,725,928,925,934