The president and FDA Commissioner Dr. Stephen Hahn made the announcement at the White House Sunday evening.
“This is a powerful therapy,” Trump said. “Today’s action will dramatically expand access to this treatment.”
So, what exactly is convalescent plasma treatment? KYW Newsradio’s medical editor Dr. Brian McDonough said those who already recovered from COVID-19 are a key part of the process.
“When someone overcomes COVID and they’re feeling better — and they are feeling better for a couple weeks — you actually can donate your blood and that plasma,” he said. “The antibodies that were victorious can be given to other people to try to boost their immune system.”
So far, 70,000 patients have received the treatment through an Expanded Access Program led by the Mayo Clinic, which enrolled 101,000 people, according to the FDA.
“There was a 35% improvement in survival, which is a significant clinical benefit,” Hahn said at the press conference.
CBS medical contributor Dr. David Agus, however, noted not everyone is on board.
“Earlier in the week, we heard that the (National Institutes of Health) and other scientific leaders were not as enthusiastic about the data,” he said. “We’re really waiting for definitive trials to show it worked more.”
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The Infectious Diseases Society of America acknowledged positive signs from the treatment, but it agreed a lot more work needs to be done.
“ISDA supports the continued collection of data in randomizes clinical trials to better understand the benefits of convalescent plasma treatment before authorizing its wider use in patients with COVID-19,” reiterated ISDA President Dr. Thomas File Jr.
The Mayo Clinic announced it would end enrollment in its program, now that the FDA expanded access.
“While the program was never intended to be a randomized clinical trial, in the course of our work, Mayo Clinic and collaborators observed potential signals of efficacy among a diverse population and chose to share those data,” said lead researcher Dr. Michael Joyner, who said they will continue to study the treatment.
The announcement comes just after the president tweeted about the FDA, claiming “the deep state, or whoever” in the organization were holding up trials to purposely hurt his reelection campaign.