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FDA Expands Authorization for Pfizer-BioNTech COVID-19 Vaccine to Include Individuals 12-15 Years Old

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New FDA authorization helps make COVID-19 vaccination available for children as young as 12 years old

The US Food and Drug Administration (FDA) announced May 10, 2021, that it has expanded the authorization for the Pfizer-BioNTech COVID-19 Vaccine to permit administration for individuals age 12 through 15 years old. The original emergency use authorization (EUA) for the vaccine issued in early December 2020 only permitted administration for individuals as young as 16 years old.

This marks the first time a COVID-19 vaccine has been authorized for use in individuals this young in the United States, as all other authorized COVID-19 vaccines are only authorized for use in adults. Immunizing children has been thought by some to be an important step in reaching herd immunity, and this recent development is a step toward reaching this goal.

The FDAs expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD. Todays 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.”

Pfizer has recently announced that clinical trials are underway that may allow the Pfizer-BioNTech COVID-19 Vaccine to be provided to children as young as 6 months old.

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