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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Sliding Scale: Bar For COVID Therapeutics EUAs ‘Can Be Somewhat Variable’ – FDA’s Peter Marks
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.
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.