The totality of evidence favors the efficacy of convalescent plasma to treat COVID-19 when high-titer plasma is administered early in the course of disease or to immunocompromised patients. In this commentary, we frame the findings of L. A. Bartelt, A. J. Markmann, B. Nelson, J. Keys, et al. (mBio 13:e01751-22, 2022, https://doi.org/10.1128/mBio.01751-22) in the context of the normal approval process for a therapeutic product. We point out that convalescent plasma has taken all of the typical steps associated with approval for a therapeutic product. Additionally, in less than 3 years, the optimal use cases and continued utility of this product to treat COVID-19 have been defined.
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