Analyzing the Evidence For The Convalescent Plasma EUA
The justification President Trump used is not directly mentioned in the decision memo, but other data suggests a less-than-overwhelming case for granting emergency use authorization.
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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.
Dosing is capped under emergency use authorizations, but studies show reduced antibody response following primary vaccination series in individuals with compromised immune systems; although BLA approval could allow for off-label prescribing, government officials are exploring other regulatory options for earlier access, including through a study.
High-profile programs, such as convalescent plasma, also created public confusion about role of preapproval access and highlighted the importance of prospectively planning for reliable data collection, experts said at the DIA global annual meeting.