Pfizer, BioNTech to Request FDA Emergency-Use Authorization for Covid-19 Shot in Children in Coming Weeks

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 [e-mail]

(END) Dow Jones Newswires

09-28-21 0715ET