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How US FDA Explained The Difference Between Approved And EUA Pfizer/BioNTech COVID-19 Vaccine

 
• By Derrick Gingery

When Comirnaty was approved in 2021, the product in the vials was identical, but the agency still had to state that legally they were different without confusing people.

Same but different
The approved Pfizer-BioNTech vaccine, Comirnaty, is not legally the same as the product available under emergency use authorization, even though the products are interchangeable. • Source: Shutterstock

The BLA review of Pfizer Inc./BioNTech SE’s COVID-19 vaccine Comirnaty raised a regulatory question that was easy to answer, but difficult to explain.

In late August 2021, Comirnaty was about to receive full approval for use in adults 16 and older

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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
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