Regulatory challenges of convalescent plasma collection during the evolving stages of COVID-19 pandemic in the United States.

Abstract

Regulations concerning COVID-19 convalescent plasma (CCP) collection during different stages of the pandemic have been challenging for the blood establishments. With the availability of advancing evidence about the safety and efficacy of CCP and the development of COVID-19 vaccines, the FDA regulations have been promptly updated at different stages of the pandemic. Evidence regarding the efficacy of high titer CCP and the antibody titer threshold required to qualify a unit as 'high titer', is still evolving. Evidence about the efficacy during early in the course of disease and in immunocompromised patients also requires larger prospective randomized controlled trials, and the major drawback of many existing clinical trials is their lack of randomization. We review the FDA regulatory updates for CCP collection during the pandemic and the challenges faced by blood donation centers, summarize the evidence for CCP efficacy, including efficacy against the SARS-CoV-2 variants and describe the future challenges and directions. This article is protected by copyright. All rights reserved.