FDA authorizes Pfizer Covid-19 vaccine for kids ages 12 to 15
WASHINGTON, DC -- The U.S. Food and Drug Administration is expanding use of Pfizer’s Covid-19 vaccine to children as young as 12.
The FDA said Monday afternoon that the shot is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers.
It's welcome news for families struggling to decide what activities are safe to resume when only the youngest family members remain un-vaccinated.
Shots could begin soon once a federal vaccine panel issues recommendations for using the vaccine in 12-to 15-year-olds. The Biden administration has said it will quickly mobilize to ready vaccinations for younger teens and adolescents through the federal pharmacy program, pediatricians and family doctors.
This is the first Covid-19 vaccine in the United States authorized for use in those ages 12 to 15; the vaccine had previously been authorized for people age 16 and older. Covid-19 vaccines from Moderna and Johnson & Johnson are authorized for use in people age 18 and older.
Expanding authorization to people 12 to 15 opens Covid-19 vaccination to another 5% of the U.S. population, nearly 17 million more people. The expanded authorization means 85% of the U.S. population is eligible to receive a Covid-19 vaccine.
Pfizer said last week it expects to submit for emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 years old in September. Its vaccine safety and efficacy study in children ages 6 months to 11 years old is ongoing.