1. Pink Sheet

Real-World Evidence Will Take Center Stage At US FDA Advisory Committee On COVID Boosters

 
• By Sue Sutter

If regulators agree with Pfizer’s conclusions – and briefing documents suggest that’s a big if – about real-world studies showing Comirnaty’s effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.

How will the advisory committee discussion run for the RWE on boosters for Pfizer’s COVID vaccine Comirnaty? • Source: Nielsen Hobbs

A US Food and Drug Administration advisory committee review of Pfizer Inc./BioNTech SE’s request for approval of a third or “booster” dose of its Comirnaty COVID-19 vaccine could be a watershed moment in the agency’s use of real-world evidence as the justification for a new indication.

Or it could be another case of the agency and its external experts being not sufficiently comfortable with use of observational data as the basis

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