The Food and Drug Administration authorizes the expanded use of Pfizer’s COVID-19 vaccine in adolescents ages 12 to 15.
“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,” acting FDA Commissioner Janet Woodcock said 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.”
Shots could be administered when a recommendation from the Centers for Disease Control and Prevention is issued.
Some parents have voiced their interest in vaccinating their children first before they go back to school so the approval for the COVID-19 vaccine for adolescents is a game changer for resuming in-person classes.
FDA’s approval also makes way to inoculate millions of children which is an important step for increasing immunity in the overall population.
Last month, Pfizer announced that it submitted a request to the FDA to expand the emergency use of its COVID-19 vaccine after it reported that the trial results of kids ages 12 to 15 “demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.”
Vaccines from Pfizer and German company BioNTech was previously approved for emergency use for ages 16 and older while COVID-19 vaccines from Moderna and Johnson & Johnson have authorized for ages 18 and older.
Last week, Pfizer filed for full regulatory approval for its vaccine from the FDA. The company is also expecting to submit a request in September to expand its vaccine use to children ages 2 to 11.