FDA approves Pfizer COVID-19 vaccine use in ages 12-15

The U.S. Food and Drug Administration (FDA) expanded emergency use authorization to the Pfizer and BioNTech novel coronavirus (COVID-19) vaccine to children ages 12 to 15 years old, according to an announcement made by the agency Monday evening.

The Pfizer and BioNTech vaccine was previous approved for individuals 16 years and older. In late March, the companies released data stating it was 100 percent effective in the 12-to-15-years-old age group. Last week, anonymous officials began speculating FDA approval for the emergency authorization expansion.

“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,” said Janet Woodcock, MD, acting FDA commissioner in a statement. “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 and BioNTech also announced last week that the companies would submit for full FDA approval for patients 16 years and older.

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