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FDA Reportedly Set To Approve Pfizer Vaccine For 12- To 15-Year-Olds

The Food and Drug Administration is preparing to expand authorization for the use of the Pfizer-BioNTech coronavirus vaccine to children ages 12 to 15 next week, granting access to millions of young Americans, according to multiple reports.

The New York Times, citing officials familiar with the plans, first reported Monday that the FDA is set to grant the drugmakers expanded emergency use authorization, a critical step in raising the country’s immunity levels that would reduce the numbers of hospitalizations and deaths.

The U.S. Centers for Disease Control and Prevention would then convene its vaccine advisory panel and recommend how the inoculations should be used in the adolescent age group. The Pfizer vaccine is already approved for those 16 and older.

The expansion would provide great comfort to schools preparing to return to some semblance of regular activity by the fall.

In March, Pfizer and BioNTech said clinical trial data showed their vaccine was highly influential in children ages 12 to 15, with strong antibody responses and no severe side effects. The companies have also begun a clinical trial into the use of the vaccine in children ages 5 to 11.

“Across the globe, we are longing for a normal life. This is especially true for our children,” Ugur Sahin, the CEO of BioNTech, said in a statement in March. “It is essential to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”

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