The Food and Drug Administration amended Pfizer's COVID-19 booster shot emergency use authorization to allow for children ages 5 to 11 to receive the vaccine.
Pfizer says the booster shot provided a "strong immune response" in children who took part in a clinical trial.
Children can receive the booster shot five months after receiving their primary two-dose series.
“The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
FDA Commissioner Robert M. Califf acknowledged that COVID-19 tends to be less severe in children than adults. He noted, however, that more children have gotten sick and been treated in the hospital during the omicron wave.
"Children may also experience longer term effects, even following initially mild disease," Califf said.
The FDA says the best protection against COVID-19 is getting vaccinated. However, there is still no vaccine available for children under 5.