FDA Authorizes Pfizer Vaccine for Kids Ages 5 to 11

The Food and Drug Administration on Friday authorized the use of Pfizer and BioNTech’s Covid-19 vaccine for children ages 5 to 11.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.

The Centers for Disease Control and Prevention shall sign off before shots can be distributed. This move will make the shots available to 28 million kids in the U.S.

Notably, the FDA clearance came after the agency’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly on Tuesday to back a smaller dose of the Pfizer vaccine for young children.

The company said its low-dose vaccine for kids, which is a third of the dosage given to adults, is more than 90% effective in preventing asymptomatic infection. It also affirmed that the shots were well tolerated in young children, producing side effects comparable with those seen in a study of people ages 16 to 25.