Pfizer, BioNTech to Request FDA Emergency-Use Authorization for Covid-19 Shot in Children in Coming Weeks
September 28 2021 - 7:30AM
Dow Jones News
By Dave Sebastian
Pfizer Inc. and BioNTech SE said they expect to request an
emergency-use authorization of its Covid-19 vaccine in children
ages 5 to 11 from the U.S. Food and Drug Administration in the
coming weeks, with submissions to the European Medicines Agency and
other regulatory authorities also planned.
The companies Tuesday said they have submitted data to the FDA
from their late-stage study.
Last week, the companies said their Covid-19 vaccine was found
to be safe and generated a strong immune response in children ages
5 to 11, bringing the prospect of broader vaccination coverage
closer.
The companies included 2,268 participants in the trial.
Write to Dave Sebastian at dave.sebastian@wsj.com
(END) Dow Jones Newswires
September 28, 2021 07:15 ET (11:15 GMT)
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