FDA halts emergency approval of COVID-19 blood plasma treatment, Mayo Clinic responds

Devin Martin
Updated: August 19, 2020 10:35 PM
Created: August 19, 2020 10:10 PM

(ABC 6 News) - The FDA has paused emergency use authorization for convalescent plasma for COVID-19. 

The Food and Drug Administration (FDA) is saying the data was not strong enough to warrant an emergency approval.

In a statement from Mayo Clinic, it states the use of convalescent plasma is a treatment approach that has long been used for various conditions and demonstrated significant improvement in health and mortality rates.

They say the program was not intended to be a clinical trial but during the trials using antibodies in those who have recovered from COVID-19 they noticed successful treatment and chose to share the data.

 "They have the burden of data and proof and they have a very difficult job and we appreciate that. From our own experiences and our own data, we believe that convalescent plasma is a safe and effective therapy if administered to the right patients at the right time,” Edward Jones, president & CEO of the research institute at Houston Methodist said.

Jones says they have conducted their own study on convalescent plasma and he says more work needs to be done.

"Our studies show that if you treat patients within three days of hospitalization, there's a decrease rate of mortality. We are not done with the pandemic, we cannot sit on our hands and wait for ideal scenarios, and we need to be smarter than that. We need to parallel process,” Jones said.

Jones believes there will be a vaccine before the end of the year, but says that outcome depends heavily on medical data.

“It will be approved by the FDA and life looks bright going into 2021. However, what if the virus mutates? We can't stop the pursuit,” Jones said.

Mayo Clinic also says it is continuing the research into convalescent plasma and will continue to send info to the FDA.


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