The U.S. Food and Drug Administration (FDA) has halted the use of COVID-19 survivor’s convalescent plasma as a potential therapy for SARS-CoV-2 based on recent media reports, including the New York Times. Top public health officials have come together, including National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, Francis Collins, MD, PhD, Director of the National Institutes of Health, encouraging the FDA to halt the authorization of the convalescent plasma until more conclusive evidence can be generated providing efficacy.
TrialSite first reported on this effort back in April. There was much hope. However, after months and thousands treated, the study authors reported that although there were some promising signals there wasn’t sufficient data to declare the treatment effective. This is an unfortunate outcome as Mayo Clinic’s Dr. Michael Joyner has organized and orchestrated a powerful national effort that raised hope and great interest from physicians to become investigators as well as patients.
On the other hand, Clifford H Lane, MD, clinical director at NIAID, was quoted by the New York Times that although the greenlight was put on hold for now an approval could be authorized in the near future. The government needs more data.