Warp Speed’s Woodcock Encourages Institutions To Continue COVID-19 Plasma Controlled Trial
Seeking to prevent negative fallout from emergency use authorization, Woodcock and NIH Director Collins ask investigators to prioritize a controlled trial of convalescent plasma currently underway in outpatients.
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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.
The emergency use authorization for convalescent plasma in August 2020 on weak data from an expanded access program has largely been viewed as a politically charged decision by the Trump administration. But newly revealed emails from the run up to the decision indicate Center for Biologics Evaluation and Research Director Peter Marks backed the plan.
US FDA and NIH leaders cite lack of early clinical trial coordination as a weakness in the pandemic response that led to use of compounds that were potentially harmful and, even today, still not proven to be effective.