Analyzing the Evidence For The Convalescent Plasma EUA
Executive Summary
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.
You may also be interested in...
Convalescent Plasma EUA ‘Could Have Been Done Better’ But Not A ‘Total Catastrophe’ – FDA’s Marks
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.
COVID Vaccine Boosters: US Exploring Ways To Get Immunocompromised People An Extra Dose
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.
Expanded Access With COVID Therapeutics Were ‘Worst-Case Scenario’ For Informed Consent
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.