Concern grows about shortage of plasma after FDA expands access to COVID-19 treatment

There is a growing concern about a shortage of plasma after the Food and Drug Administration moved to expand access to the COVID-19 treatment.

The FDA issued an ’emergency use authorization’ for convalescent plasma Sunday, which will make the blood antibody therapy more widely available.

Previously, COVID-19 patients could only receive plasma through a clinical trial or investigational program, such as the nationwide Expanded Access Program led by Mayo Clinic.

"If it becomes more readily accessible, it will become more widely used and may veer into the ‘scarce resource’ terrain," said Dr. Frank Rhame, an infectious disease specialist at Abbott Northwestern Hospital in Minneapolis. "We’re going to have to decide how we’re going to deal with it if it becomes a scarce resource."

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Rhame is the physician in charge of registering COVID-19 patients for plasma for the Allina Health system. He said he registers three to five patients per day for the treatment, and the turn-around time has been about one day.

Rhame said Allina Health, so far, has not had trouble ordering plasma. But he worries that more patients across the country will start requesting it, which could result in a dwindled supply and delays.

He said if that happens, doctors will have to make difficult decisions about which patients receive plasma and which ones do not.

"That’s hard to do," Rhame said. "That means some people who want it, and who I’d give it to if I had it, don’t get it. That’s the nature of triage, and it is a painful process."

The American Red Cross acknowledged there is already an "emergency shortage" of plasma in the United States.

The Red Cross said, as of Aug. 24, it has collected convalescent plasma from 325 donors in Minnesota, resulting in more than 600 convalescent plasma products to treat patients across the country, including 375 convalescent plasma units to hospitals in Minnesota.

The organization provided 5 EYEWITNESS News this statement about the recent updates:

"The American Red Cross is pleased that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for convalescent plasma as a treatment for COVID-19. This EUA will help ensure more patients have access to this potentially lifesaving treatment, providing greater hope to individuals and their families during this difficult time.

"It is critical that people who have recovered from COVID-19 roll up their sleeves to donate plasma, so we can help ensure patients have access to the medical treatment they need. The Red Cross is currently distributing convalescent plasma faster than donations are coming in-resulting in an emergency shortage of these much-needed products."

Memorial Blood Centers also told 5 EYEWITNESS News that the need for COVID-19 convalescent plasma (CCP) continues, and as cases continue to rise in our area, they expect an increasing need for donations.

They also said the FDA’s criteria for donating plasma is more stringent than the previous programs, so it "is likely that up to half of CCP prospective donors will not meet FDA’s higher antibody criteria," which could also lead to a decrease in the supply of plasma across the country.

Memorial Blood Centers said they have distributed more than 3,000 plasma donations so far. They encourage recovered COVID-19 patients who have been symptom-free for 14-plus days to consider donating to help others in need.

"I just felt it was so important," said Jody Ross of Minnetonka, who’s donated plasma twice.

Ross tested positive for COVID-19 in March.

"Seeing how even a mild case like I had took me down for two full weeks, I felt that if I had something to contribute to try to make this better or alleviate suffering, I would," Ross said. "I love that when I give plasma, I don’t know who’s going to receive it, but I do know that it’s someone’s dear loved one and that means a lot to me as a neighbor."

While convalescent plasma is still being studied, the FDA authorization noted, "The known and potential benefits of the product outweigh the known and potential risks of the product" and "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."

FDA Commissioner Dr. Stephen Hahn said, "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."

Mayo Clinic said it will "discontinue enrollment" in its Expanded Access Program on Aug. 28, since the FDA has now authorized the emergency use of plasma.