FDA authorizes Pfizer-BioNTech COVID-19 vaccine use for children age 12 to 15

WASHINGTON — The U.S. Food and Drug Administration on Monday expanded the Pfizer-BioNTech’s emergency use authorization for its COVID-19 vaccine to include adolescents between the ages of 12 and 15.

The drugmakers originally obtained the FDA’s authorization on Dec. 11 for use of the two-dose vaccine in individuals 16 years of age and older.

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Acting FDA Commissioner Dr. Janet Woodcock called Monday’s authorization a “significant step in the fight against the COVID-19 pandemic.”

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodock said in a prepared statement.

>> Related: FDA expected to approve use of Pfizer’s COVID vaccine for 12- to 15-year-olds by next week

The companies stated in late March that a clinical trial of more than 2,000 adolescents found the vaccine to be 100% effective and that it “elicited a ‘robust’ antibody response in the children, exceeding those in an earlier trial of older teens and young adults,” CNBC reported.

Moderna and Johnson & Johnson, whose vaccines are authorized for people 18 and older, are also testing their shots in younger age groups, the network reported.

According to the FDA, roughly 1.5 million COVID-19 cases in individuals aged 11 to 17 were reported to the U.S. Centers for Disease Control and Prevention between March 1, 2020, and April 30, 2021.

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