FDA issues emergency authorization for convalescent plasma as potential COVID-19 treatment
The U.S. Food and Drug Administration (FDA) issued emergency use authorization on Sunday for investigational convalescent plasma for the treatment of the novel coronavirus (COVID-19), according to a statement released by the agency.
According to the FDA, the decision was based on “scientific evidence” outlined in its decision memorandum. Officials say the product may be effective in treating COVID-19 and the known and potential benefits of the product outweigh the known and potential risks of the product.
The FDA initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications.
An Expanded Access Program for convalescent plasma was initiated in early April to provide patient access to a medical product of possible benefit during a time that the FDA was working with researchers to facilitate the initiation of randomized clinical trials to study convalescent plasma, according to the agency.
As the number of single patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date, the program has facilitated the infusion of over 70,000 patients with convalescent plasma, the agency said.
Following the announcement, the Infectious Diseases Society of America published a statement on social media by its president, Thomas File, Jr., MD, FIDSA, noting the data to date shows some positive signals, but lacks the randomized controlled trial data needed to better understand its utility in COVID-19 treatment.
Additionally, the World Health Organization’s chief scientist said in a statement on Monday the evidence remains “low quality,” and requires further investigation. The general consensus in the scientific community has been the treatment is experimental at best and data remains inconclusive.