WASHINGTON — The FDA unveiled a new website to help facilitate donations of convalescent plasma from individuals who have recovered from Covid-19.
“Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus,” said Stephen M. Hahn, MD, FDA Commissioner of Food and Drugs in a statement. “Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by Covid-19. It is important that we evaluate this potential therapy in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients, as appropriate.”
The Donate Covid-19 Plasma website explains that, in order to donate, “individuals must have had a prior diagnosis of Covid-19 documented by a laboratory test and meet other donor criteria,” and their symptoms must have been resolved for at least 28 days prior to donation, or have a negative lab test and be symptom free for at least 14 days.
Individuals can donate by contacting American Red Cross or a local blood center.
“The response to the agency’s recently announced national efforts to facilitate the development of and access to convalescent plasma has been tremendous,” Hahn noted. “More than 1,040 sites and 950 physician investigators nationwide have signed on to participate in the Mayo Clinic-led expanded access protocol. A number of clinical trials are also taking place to evaluate the safety and efficacy of convalescent plasma and the FDA has granted numerous single patient emergency investigational new drug (eIND) applications as well.”
The new webpage also has a link to guidance about investigational convalescent plasma for health care providers and investigators.
The guidance covers how convalescent plasma can be used: clinical trials or expanded access for seriously ill patients; patient eligibility; collection; and labeling and record keeping.
The FDA noted that Covid-19 convalescent plasma is not approved for use by the agency and that, in order to use it, a health care provider must be enrolled in one of the pathways. The convalescent plasma can only be obtained from an FDA-registered blood establishment.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 125
Topic ID: 79,125,287,125,190,469,520,926,192,927,150,151,928,925,934