The Food and Drug Administration cleared the Pfizer-BioNTech COVID-19 booster dose for children ages 12-15 on Monday.
The omicron variant is spreading rapidly among younger people in the U.S. According to NBC News data, on Sunday the U.S. set a record for total pediatric patients hospitalized with confirmed and suspected COVID-19, pointing to the need for young teens to be vaccinated against the disease.
The FDA also shortened the timing of booster shots from six months to five months after the initial series of shots in this age group, based on Israeli research.
Studies of more than 6,300 teens ages 12 to 15 in Israel suggested that a booster dose may protect kids from the omicron variant better when given at five months, rather than six.
“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19,” acting FDA commissioner Dr. Janet Woodcock said in a media statement.
The agency said it found “no new safety concerns” following a booster shot in young teenagers, and that there were no new reports of two types of heart inflammation called myocarditis or pericarditis linked to the boosters.
Monday’s action from the FDA also includes a third vaccine dose for children ages 5-11 who have specific immune system deficiencies, such as those who have had organ transplants.