March 27, 2020
IDSA Supports FDA Action on Emergency Investigational Convalescent Plasma Treatment for COVID-19
The Infectious Diseases Society of America commends March 24 action by the U.S. Food and Drug Administration to open access through its emergency Investigational Drug Applications to treatment with COVID-19 convalescent plasma for patients suffering severe or life-threatening impacts of the disease.
While questions regarding dosage, indications for use, safety, and potential effectiveness remain to be answered before the approach can be used to prevent infections, the use of convalescent plasma collected from patients who have recovered from viral illnesses has been used with success in the absence of vaccines and has been investigated in treatment for H1N1 and MERS-CoV during outbreaks of diseases caused by those viruses. The exploration of a wide range of options for treating increasing numbers of patients who are very ill with COVID-19 will be essential.
In a letter to FDA Center for Biologics and Research Director Dr. Peter Marks, M.D. PhD, IDSA encourages joint efforts on the part of academia, industry, and the federal government to expedite scientific progress and regulatory approval of this promising approach, and offers its assistance in facilitating the collaboration needed.