FDA authorizes Pfizer COVID-19 vaccine in adolescents 12 and up

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(WAOW) — The U.S. Food and Drug Administration has expanded the  emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine.

It is now approved for adolescents 12-15 years of age.

Pfizer was the first vaccine approved in the fight against the COVID-19 pandemic, back in December of 2020.

Acting FDA Commissioner Janet Woodcock, M.D., made the following statement on the expansion.

“The FDA’s 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, M.D. “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.”

According to the FDA, expanding the EUA means the vaccine meet the statutory criteria and that “the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.” 

An EUA is not a full approval for the vaccine, although Pfizer and BioNTech has started the process of getting full approval.

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