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Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review

 
• By Sue Sutter

Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.

Drug Review Profile: Comirnaty
US FDA's Review of Pfizer/BioNTech SE’s COVID-19 vaccine became unexpectedly more complicated mid-cycle with the emergence the myocarditis side effect.

The occurrence of myocarditis cases among older male adolescents and young men who received Pfizer Inc./BioNTech SE’s COVID-19 vaccine drew extensive focus from the US Food and Drug Administration late in the Comirnaty biologics license application’s speedy review.

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