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Pfizer, BioNTech Receive EUA for COVID Vax in Children 5 to 11

Clinical data show a favorable safety profile and vaccine efficacy of 90.7%, becomes first vaccine available in this age group.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Pfizer Inc. and BioNTech SE received authorization from the U.S. FDA for emergency use of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age. The vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for this age group.   The FDA based its decision on data from a Phase 2/3 randomized, contro...

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