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Placebo Unblinding Process For Pfizer’s COVID Vaccine No Detriment To US FDA Safety Analysis

 
• By Sue Sutter

Despite initial concerns among FDA staff and its advisory committee about unblinding the Comirnaty pivotal trial after emergency authorization, agency’s review of the first COVID vaccine to receive full licensure suggests its safety conclusions were not adversely affected.

Drug Review Profile: Comirnaty
When Pfizer/BioNTech opened the door to placebo recipients to get vaccinated, the FDA worried about how interpretation of the study results would be impacted.

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 then separately for the open-label period

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