CHICAGO (CBS) — The U.S. Food and Drug Administration on Monday authorized the Pfizer-BioNTech COVID-19 vaccine for children ages 12 to 15.
“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,” Acting FDA Commissioner Dr. Janet Woodcock said in a news release. “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.”
From March 1 through April 30, about 1.5 million COVID-19 cases were reported to the Centers for Disease Control and Prevention in young people between the ages of 11 and 17. Children and adolescents usually have milder cases of COVID-19 than adults, the FDA noted.
The FDA has determined the Pfizer vaccine has met the statutory criteria to amend the emergency use authorization for younger ages – and that the benefits outweigh the risks for everyone age 12 or older.