FDA Guideline Change Following Improvements In COVID-19 Plasma Treatment

FEBRUARY 26, 2021

GRAND RAPIDS - As the United States surpassed half a million COVID-19 deaths this week, there is good news for treatment options as the Food and Drug Association revised guidelines for the use of convalescent plasma easier this month.
“Based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020, we have revised the EUA to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients early in the disease course", the revised FDA Letter of Authorization stated.

The changes come after studies conducted last year showed that critically ill patients were too sick for certain amount of the treatment to work. But the focus has turned to use of high titer plasma on patients early in hospitalization.

“Sooner you give it to a patient, the better it is to help them recover", said Dr. Dan Waxman, vice president of transfusion medicine of Versiti. The blood research institute is still collecting donations under the new guidelines.

What is Convalescent Plasma?
Convalescent plasma is a passive antibody therapy that goes back to the Spanish Flu Pandemic with most recent use during Ebola Epidemic, he explained.

“You have one individual who has been infected by a virus, has recovered, and has developed natural immunity and antibodies to that virus", he said.
I made my donation last week at their Michigan offices in Grand Rapids after I recovered from a mild case of COVID-19 in November. During the process, 600 to 800 ml of plasma are collected. That is mixed with 200 ml of frozen plasma. 1 to 2 units are sent for transfusion in an inpatient setting.
During a zoom interview, Dr, Waxman explained that there are two types of donors. There are those that were clinical ill with a positive nasal swab test or those that are found through an antibody test, either from an outside source or from testing Versiti conducts on all blood and platelets donors. Recently, 18 to 19 percent of their donor population have been found to have antibodies, he said. It then comes down to the level of antibodies.

"We will look at your antibody level, and see if it's what's called high titer versus low titer and the only way to differentiate is just the strength of the antibody on the tests that we're doing," he said. "Clinical studies are showing that if you give these high titer units, meaning people with higher amount of the antibody based on these tests, then those are the units that will have the most clinical affect for a patient".

Donors with this type of plasma can make up to 12 donations.

Looking ahead, Dr. Waxman was optimistic of the treatment's progress.
"We learned a lot in a year. We now have good tests to show who high titer, who is low titer. We test every donor every time," he said.
With orders declining along with hospitalization, some plasma will be used to make hyperimmune globulin compounds for therapeutic treatments but donation types of blood and platelets are needed. Those types of donations can be done by anyone that qualifies, even those that had their COVID-19 vaccines.
"Better to have people who were vaccinated and had COVID or never had COVID just have them be regular blood and platelets donors, which we need," he said.

How To Donate:
To find the nearest donation center or learn more about convalescent plasma, the FDA has a website at www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/donate-covid-19-plasma. Donations through Versiti can be scheduled on their website at www.Versiti.org.