Convalescent Plasma EUA ‘Could Have Been Done Better’ But Not A ‘Total Catastrophe’

Convalescent Plasma EUA ‘Could Have Been Done Better’ But Not A ‘Total Catastrophe’ – FDA’s Marks

11 Feb 2022

Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.

Hot air balloon — The size of the COVID-19 convalescent plasma expanded access program ballooned out of control, FDA's Peter Marks says. • Source: Alamy

Reliance on expanded access data to support the COVID-19 convalescent plasma emergency use authorization was the appropriate decision at the time, but the experience offers lessons in the shortfalls of uncontrolled data, problems created by rapid growth of expanded access programs, and the need to push for randomized controlled studies as early as possible.

Those were some of the takeaways from the convalescent plasma experience shared by US FDA Center for Biologics Evaluation and Research officials last month at a conference hosted by the New York University Division of

Convalescent Plasma EUA ‘Could Have Been Done Better’ But Not A ‘Total Catastrophe’ – FDA’s Marks

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