FDA's COVID-19 Plasma Authorization On Hold, Still Possible
The US FDA was said to be considering an emergency authorization for COVID-19 plasma just last week. For now, the authorization is on hold.
The US Food and Drug Administration (FDA) was said to be considering an emergency authorization for COVID-19 plasma just last week. But now, the authorization is on hold.
Last week, authors in The American Journal of Pathology reported that transfusing critically ill COVID-19 patients with high antibody plasma early in their illness—within 72 hours after hospitalization proving most effective—reduced the mortality rate.
Convalescent plasma is donated by survivors of COVID-19. The treatment was found safe in recent studies, but as with many COVID-19 therapeutics the exact efficacy is still an open question.
According to H. Clifford Lane, MD, the clinical director at the National Institute of Allergy and Infectious Diseases, the authorization is on hold while more data are reviewed.
However, it is worth noting that in contexts where treatment is possible, evidence is promising.
"Our studies to date show the treatment is safe and, in a promising number of patients, effective," James Musser, MD, PhD, chair of the Department of Pathology and Genomic Medicine at Houston Methodist said. "While convalescent plasma therapy remains experimental and we have more research to do and data to collect, we now have more evidence than ever that this century-old plasma therapy has merit, is safe and can help reduce the death rate from this virus."
An emergency authorization could still be issued in the near future, Lane noted. The concern is over acting too quickly.
There are also concerns about scaling the treatment up.
David Ho, MD, of the Columbia University Vagelos College of Physicians and Surgeons, recently commented on the logistics of plasma.
“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 to Contagion sister-site HCPLive.
Recovered patients with more severe COVID-19 cases are reporting greater titers, but it’s not standard practice to collect samples from patients previously treated in intensive care units (ICUs).
“For every plasma unit you receive, you could probably help 1 or 2 cases,” Ho said. “It’s hard to scale.”
According to New York Times reporting, Dr. Anthony Fauci was one of 3 public health officials who stepped In, alongside Lane and Dr. Francis S. Collins.
“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said in an interview on Tuesday.