Convalescent Plasma EUA Will Not Complicate Hyperimmune Globulin Product Development, Sponsors Say

US FDA authorization will further boost already-high demand for plasma from individuals recovered from COVID-19 and increase competition for donors, NYU’s Arthur Caplan predicts, but CoVIg-19 Plasma Alliance and Emergent BioSolutions say they do not expect EUA to impact either product supply or enrollment in upcoming randomized trials of their H-Ig products.

Packages with donated plasma and blood
EUA may boost demand for convalescent plasma and competition for donors. • Source: Shutterstock

The US Food and Drug Administration’s emergency use authorization for COVID-19 convalescent plasma is not expected to complicate industry efforts in the US to develop pharmaceutical-grade hyperimmune globulin products made from the same material, industry representatives say, despite one expert’s concerns to the contrary.

New York University bioethicist Arthur Caplan predicted the EUA will further boost demand for much-needed plasma from individuals who have recovered from SARS-CoV-2 infection. In addition, donors may be more...

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