Yesterday the Food and Drug Administration released a clinical memorandum giving Emergency Use Authorization for COVID-19 Convalescent Plasma (CCP) therapy, a previously unapproved biological product. For several months clinicians treating severely ill COVID-19 patients have transfused plasma donated by convalescing COVID-19 patients, rich with the antibodies to the virus produced by their immune system, hoping that these same antibodies can help patients suffering from active infection. Early results have been promising but, as some critics of the FDA decision have stated, more data is needed before definitive conclusions can be drawn regarding the efficacy of CCP therapy.
Using the antibodies in plasma from patients who have defeated a viral infection to treat newly infected patients is not a new idea. Clinicians and clinical researchers used it as early as the late nineteenth century to treat diphtheria and it was employed in the early twentieth century in the Spanish influenza epidemic.
By issuing the EUA allowing physicians to use convalescent plasma, the FDA didn’t make a final determination as to the treatment’s efficacy. The agency stated it “may be effective.” Importantly, it concluded that the treatment is safe. The FDA press release stated, “the known and potential benefits of the product outweigh the known and potential risks of the product.”
Read more at https://www.cato.org/blog/fda-determined-convalescent-plasma-safe-leaves-decisions-efficacy-clinicians/patients-thats
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