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Pfizer’s COVID-19 Vaccine Data In Young Children Could Place US FDA In Awkward Position Again

 
• By Derrick Gingery

The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.

Child vaccination
More Pfizer data on the efficacy of its COVID-19 vaccine in children younger than 5 is expected in the coming months. • Source: Alamy

US Food and Drug Administration officials are preparing for a potentially complicated assessment of the Pfizer Inc./BioNTech SE coronavirus vaccine in young children as pressure grows to find ways to better protect them during the Omicron surge.

The ongoing Comirnaty clinical trial did not meet its non-inferiority endpoint in the 2- to 5-year-old age group, but did achieve the success criteria in children age 6 months to 2 years old

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