The newest authorization comes following a week of clinical, legislative, and public health debate surrounding the realistic benefit of the survivor-extracted therapy.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the use of convalescent plasma in treating coronavirus 2019 (COVID-19).
The authorization comes after a week of cyclical debate among public health officials and legislators, as well as clinical appraisal among investigators—which have both come to highlight most agents granted emergency authorization by the FDA.
In a release Sunday evening, the FDA stated its decision is based on available scientific evidence indicating convalescent plasma may be beneficial for COVID-19, and that the known and potential product benefits outweigh its understood risks.
“Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing,” the FDA stated.
In a statement accompanying the decision, FDA Commissioner Stephen Hahn, MD, expressed encouragement from “early promising data” for 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,” Hahn said. “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.”
Data published in The American Journal of Pathology this month showed high-antibody plasma transfused in patients critically ill with COVID-19 within 72 hours of hospitalization was effective in reducing mortality rate.
Though the clinical benefit may be apparent for severely at-need hospitalized patients, experts have recently walked back earlier excitement over the coronavirus survivor-extracted therapy.
HIV/AIDS pioneer researcher David Ho, MD, of Columbia University Vagelos College of Physicians and Surgeons, told Contagion® sister publication HCPLive® on an episode of Lungcast that while results are still pending in New York-based research of plasma, he anticipates it will not reach the successes observed in China—if not only because of timing and priority of plasma collection.
As he noted, it is uncommon in the US for plasma samples to be collected from patients who recovered in intensive care units (ICUs)—an indication of stronger antibody.
“And we now know there’s extreme variability in antibody titers—particularly if one had only mild disease, then the antibody titers are unimpressive and probably not helpful,” Ho said.
For every plasma unit received, Ho projected, about 1-2 cases could be benefitted—a difficult-to-scale therapy.
Speaking more optimistically at the time of the EUA, former FDA commissioner Scott Gottlieb, MD, tweeted that convalescent plasma is “probably incrementally helpful” to patients with COVID-19, meeting the authorization criteria.
My Op Ed tonight. Plasma is probably incrementally helpful to Covid patients and meets criteria for an EUA. But we need better evidence generation; and we need to keep FDA decisions with FDA. The FDA professional staff supported this. It’s their decision. https://t.co/hHZDhaJchd
— Scott Gottlieb, MD (@ScottGottliebMD) August 23, 2020
But, Gottlieb stressed, greater evidence needs to be generated.
“The FDA professional staff supported this,” he wrote. “It’s their decision.”