FDA’s Emergency Approval of Blood Plasma as COVID-19 Treatment?

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FDA had put on hold the the use of plasma as treatment for COVID-19 last week. Initially, scientists observed positive results for patients who received convalescent plasma from patients who had survived the coronavirus. 

Indeed, these patients’ bodies have developed antibodies that can help other patients. However, the recent data shows that there is not sufficient evidence to grant emergency use authorization for this treatment.

“Per policy, we are not able to comment on whether or not we will take any action regarding emergency use authorization for convalescent plasma,” the FDA said last week.

In fact, an FDA emergency-use authorization would enhance the availability of a therapy in a clinical setting for the pandemic.

In addition, doctors were using a variety of techniques across the country as per a FDA program to expedite experimental therapy that might be the only option for some patients. They recorded the outcomes for patients and cannot conclude that the plasma caused patients’ recovery.

Moreover, clinical trials use criteria to better determine what variables with a treatment could lead to better patient outcomes. While the plasma showed signs of efficacy according to a lead researcher at the Mayo Clinic, the recent data persuaded the FDA to seek an alternative.

“For 102 years we’ve been debating whether or not convalescent plasma works,” said Dr. Mila Ortigoza, of New York University, referring to plasma’s use in the 1918 flu pandemic. This time around, “we really need undisputable evidence.”

Ortigoza is co-leading a clinical trial, which will also include Connecticut, Florida, and Texas. Her team aims to collect evidence from other studies and analyze comprehensive data to determine the best approach.

“There’s concern about when there will be a clear answer,” agreed infectious disease specialist Dr. Jeffrey Henderson, of Washington University in St. Louis.

What is more, Dr. Henderson said that Mayo report is consistent compared to other studies on plasma and “an example of making the best you can of the data that’s available.” He believes there is still hope for something efficacious.

The Mayo Clinic published their results online for scientific peer review. The data indicates that 20% of people who received high-antibody plasma within three days of diagnosis had died within 30 days, compared with 30% of people that were treated with low-antibody plasma.

The Associated Press contributed to this story.

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