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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...

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

 
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EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
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US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.