Despite much gnashing of teeth by the US Food and Drug Administration and its external experts about when and how to unblind placebo patients in Pfizer Inc./BioNTech SE’s Phase II/III trial of its COVID-19 vaccine, the process does not appear to have negatively impacted the agency’s ability to review safety data for Comirnaty.
In review documents supporting the August licensure of Pfizer/BioNTech’s mRNA vaccine in individuals ages 16 years and older, the FDA analyzed safety data specific to the study’s double-blind period, and...