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Children ages 5-11 years are now eligible for a bivalent COVID-19 vaccine booster.
Leaders of the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) signed off on the updated boosters for children today. The AAP supports administration of all COVID vaccine primary series and booster doses recommended by the CDC.
The Pfizer-BioNTech bivalent booster emergency use authorization that includes people 12 years and older has been expanded to include children ages 5-11 years. The Moderna bivalent booster authorization for those 18 and older has been expanded to include children and adolescents ages 6-17 years.
“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” FDA Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., said in a press release. “Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death.”
He noted even mild COVID cases in children have the potential to cause long-term effects.
The bivalent boosters were created to combat a possible fall/winter virus surge and contain both the original SARS-CoV-2 strain and the omicron BA.4/5 spike protein. About 79% of the circulating strains are BA.5, and the rest are other omicron variants, according to the CDC.
Children as young as 5 years who have completed a primary series are eligible for a single bivalent booster two months after previous doses. About 61% of adolescents ages 12-17 years and 32% of children 5-11 years have completed a primary series. Children can receive a bivalent booster with a different brand than their primary series.
The Pfizer-BioNTech bivalent booster dose for children ages 5-11 years is 10 micrograms (μg). Moderna’s bivalent booster dose is 50 μg for adolescents ages 12-17 years and 25 μg for children ages 6-11 years.
FDA authorization was based on immune response and safety data from clinical studies in adults of a bivalent booster containing the original SARS-CoV-2 strain and an omicron BA.1 strain. Officials also considered data from clinical studies on monovalent boosters in children.
As with people ages 12 and older, monovalent boosters no longer are allowed for children ages 5-11 years now that a bivalent booster has been authorized.
- FDA fact sheet for health care providers administering Pfizer-BioNTech bivalent boosters
- FDA fact sheet for health care providers administering Moderna bivalent boosters
- CDC planning guide for bivalent COVID vaccine boosters
- CDC information on COVID-19 vaccine boosters
- CDC clinical considerations for administering COVID-19 vaccines
- AAP COVID vaccination resources
- AAP pediatric COVID-19 vaccine dosing quick reference guide
- AAP/Health and Human Services COVID vaccine toolkit
- Information from HealthyChildren.org on preparing children for a COVID-19 vaccine