FDA set to authorize the Pfizer vaccine for those 1215 years old by early next week.

The U.S. Food and Drug Administration is poised to authorize Pfizer/BioNTech’s coronavirus vaccine in children and teens ages 12 to 15 by early next week, a federal government official told CNN.

Pfizer has applied for emergency use authorization for its coronavirus vaccine for teens and children ages 12 to 15. The FDA will have to amend the emergency use authorization for the vaccine, but the process should be straightforward, said the official, who was not authorized to speak about the process publicly and requested anonymity.

The FDA is currently reviewing data submitted by Pfizer to support the extended use. Pfizer said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed its efficacy is 100% and it is well tolerated. The vaccine is currently authorized in the U.S. for emergency use in people 16 and older.

Before issuing the emergency use authorization for the three authorized coronavirus vaccines, the FDA held meetings of its independent Vaccines and Related Biological Products Advisory Committee to review the data and vote on whether to recommend authorization. That will not happen in extending authorization to 12-to-15-yearolds, the FDA has told CNN.

“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and sciencebased approach,” the FDA said in an email to CNN last week.

A Centers for Disease Control and Prevention advisory committee known as the Advisory Committee on Immunization Practices will schedule a meeting for after any FDA decision to extend the authorization to new age groups. ACIP will advise the CDC on whether to recommend use of the vaccine in 12-to15-year-olds, and then CDC Director Dr. Rochelle Walensky will decide whether the agency will recommend its use in the new age group.

Pfizer and Moderna both are testing their vaccines in children as young as 6 months and expect to ask the FDA for emergency use authorization covering infants and children later this year.