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U.S. FDA Authorized Pfizer COVID-19 Shots for Ages 12-15 Years

The US Food and Drug Administration is poised to authorize Pfzer/BioNTech’s COVID-19 vaccine in children and teens ages 12 to 15 years by early next week.

Pfizer has applied for emergency use authorization for its coronavirus vaccine for teens and children ages 12 to 15. An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.

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 US for emergency use in people 16 and older.

The CDC opened up vaccine eligibility to people who were 16 years or older in April, and those who were 16 or 17 years old were allowed to receive only Pfizer’s shot, while those 18 and up were authorized to receive Moderna‘s or Johnson & Johnson‘s vaccines as well.

Pfizer CEO Albert Bourla said in a statement in March that the company shared the “urgency to expand the authorization of our vaccine to use in younger populations.” He said he hoped the clinical-trial data would prompt officials to start vaccinating the age group “before the start of the next school year.”