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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...

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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
• By Bridget Silverman

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

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