Pfizer submits data to FDA for kids' COVID vaccine

Tuesday, 28. September 2021 13:04

Pfizer Inc. and BioNTech SE announced on Tuesday that they have shared the data from the phase 2/3 trial of their coronavirus vaccine in ages five to 12 with the United States Food and Drug Administration.

The companies said that the data has been submitted to the agency as part of the initial review for the usage of the vaccine in this age group. Additionally, they stated that they intend to file for Emergency Use Authorization (EUA) for their coronavirus vaccine in children ages five to 12 "in the coming weeks."

Lastly, Pfizer and BioNTech noted that they also intend to apply to the European Medicines Agency (EMA) and other regulatory bodies. They also announced that trial data for ages two to five and six months to two years is expected to be released by the fourth quarter of the year.

Related Links: BioNTech SEPfizer Inc.
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Breaking the News / OL