Jan. 3 (UPI) — The Food and Drug Administration on Monday gave emergency authorization for children between 12 and 15 to receive booster doses Pfizer’s COVID-19 vaccine.
The move, which had been expected this week, is one of the final regulatory steps needed before extra doses can be administered to teenagers in the United States.
The Centers for Disease Control and Prevention still has to sign off on the booster doses for kids 12-15.
The FDA’s authorization came as millions of children nationwide returned Monday to classrooms after the holiday break, as well as rising cases driven by the Omicron variant.
Monday’s guidance also shortens the time period between the second dose and the booster shot, from six to five months.
“The need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
“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.”
The FDA said its decision is based partly on real-world data from Israel that studied more than 6,000 teens who’d received a booster dose of the Pfizer vaccine.
“The data shows there are no new safety concerns following a booster in this population,” the agency said in a statement.
The CDC is expected to sign off on the extra booster dose for teens as soon as Monday.
