FDA Head Highlights New Potential Coronavirus Treatment For Which FDA Has ‘Enthusiasm’

Dr. Stephen Hahn, Commissioner of the U.S. Food and Drug Administration, said during the White House Coronavirus Task Force press briefing on Saturday that the FDA is working on blood-related therapies for the coronavirus.

“One other thing I’d like to mention is that we, on Friday, stood up a formal convalescent plasma program. We have a great deal of enthusiasm for that,” Hahn said. “There are some reports that this is a benefit to patients in other countries who have had COVID-19 virus, and what this means is taking plasma from patients who have had the virus and who have recovered, and transferring the immunity, the immunoglobulins, from that person to someone who’s sick.”

“And we’re, hopefully, expanding that across the country,” Hahn continued. “The Red Cross is involved in that program, and I think it shows great promise. It needs to be studied like other things, but just like I said before, provides hope. We don’t want to provide false hope, but definitely hope.”

Dr. Stephen M. Hahn

✔@SteveFDA

Based on prior experience with respiratory viruses & on data from China, convalescent plasma – the plasma from the blood of recovered #COVID19 patients – may potentially lessen severity or shorten the illness caused by #COVID19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-coordinates-national-effort-develop-blood-related-therapies-covid-19 …

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Later in the press conference, a reporter asked Hahn, “Can you walk us through if that’s working, and is it kind of like a case by case basis?”

“So, this is a situation where someone who has recovered from the virus, doesn’t have the virus in their system at all, you can take plasma, and this is a pretty routine procedure,” Hahn responded. “You can actually donate a couple times a week, a couple times a month frankly, and give that plasma. That plasma contains the proteins in the blood that have the antibodies against the virus. You can take that, process it, and give it to someone who is ill. And so that allows you to transfer immunity.” 

“Doesn’t have to be matched by family or anything like that. Since last Tuesday, the Tuesday before last, we’ve allowed academic centers and other laboratories and hospitals around the country to do this on a compassionate use basis,” Hahn continued. “What we did was we pulled this together in what’s called an expanded access program and run it through the Red Cross because they‘ve got the greatest system and capacity for doing this. This allows us to scale up so that when people get sick we can actually have these donated plasma packs given to the patients who are sick.”

Ian Miles Cheong

✔@stillgray

Dr. Stephen Hahn says people who've recovered from COVID-19 can donate their plasma with antibodies allowing them to transfer their immunity and help others to resist the infection.

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Hahn noted that the FDA made the announcement and is partnering with the Red Cross in the effort.

“Notably, the FDA has led an effort, working collaboratively with our industry, academic, and government partners to develop and implement a protocol that will provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place,” the FDA said on Friday. “This will allow for a simplified process for providers that will help to ensure patient safety, while also allowing for the collection of needed information about product efficacy.”

“In this partnership, the Mayo Clinic will serve as the lead institution for the program and the American Red Cross will help collect plasma and distribute it for use in patients across the country,” the FDA continued. “The program was developed with funding from the Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary of Preparedness and Response. The FDA anticipates that this collaborative effort will be able to move thousands of units of plasma to the patients who need them in the coming weeks.”