FDA Approves 'Significant Step' Toward Ending Pandemic

Pfizer vaccine approved for 12 to 15-year-olds
By Rob Quinn,  Newser Staff
Posted May 10, 2021 4:58 PM CDT
FDA Authorizes Pfizer Vaccine for Ages 12 to 15
A vial of the Pfizer vaccine for COVID-19 in Seattle.   (AP Photo/Ted S. Warren, File)

The first coronavirus vaccine approved for adults and older teens in the US is now the first to gain approval for adolescents as well. The Food and Drug Administration announced Monday that the emergency use authorization for the Pfizer/BioNTech has been expanded to include people 12 to 15 years old. Acting FDA Commissioner Janet Woodcock described the move as a "significant step" that will bring us "closer to returning to a sense of normalcy and to ending the pandemic," NPR reports. In March, Pfizer said clinical trials had shown its vaccine had "100% efficacy and robust antibody responses" in children 12 to 15.

The FDA has been reviewing the amended application from Pfizer for more than a month, reports the Hill. "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," Woodcock said. Moderna and Johnson & Johnson are also studying the effectiveness of their vaccine in children. Pfizer says it plans to ask for new emergency use authorizations for children as young as 2 in September. (More coronavirus vaccine stories.)

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