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Pfizer, BioNTech Seek COVID Vax EUA in Babies 6 Months Through 4 Years

At the request of the FDA, the companies submit available data on safety and efficacy of two 3 µg doses as part of a three-dose primary series.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Pfizer Inc. and BioNTech SE announced that following a request from the U.S. FDA the companies have initiated a rolling submission seeking Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age. This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming mon...

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