The Food and Drug Administration (FDA) is expected to authorize the
Pfizer-BioNTech COVID-19 vaccine for children and teens between 12 and
15 years old by early next week.
This is according to federal officials who spoke to The New York Times.
In early April, Pfizer-BioNTech requested an amendment of the existing emergency use authorization (EUA) to expand use of the vaccine to this younger age group.
Right now, their vaccine is only approved in the United States for those 16 years old and over.
The FDA is currently reviewing data submitted by Pfizer and BioNTech.
The companies reported at the end of March that a phase 3 clinical trial involving 2,260 12- to 15-year-olds showed that the vaccine had an efficacy of 100 percent in this age group. It was also well tolerated.