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FDA authorizes updated COVID-19 boosters for children as young as 5 years old

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The U.S. Food and Drug Administration (FDA) has amended the emergency use authorizations of the Moderna and Pfizer-BioNTech vaccine bivalents to authorize their use as a single booster dose in younger age groups.

Moderna’s vaccine bivalent is permitted for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech bivalent is approved for administration at least two months following completion of primary or booster vaccination in children down to five years of age.

“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. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” Peter Marks, M.D., Ph.D. said. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”

With Wednesday’s FDA report, the monovalent Pfizer-BioNTech COVID-19 vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna and Pfizer-BioNTech COVID-19 vaccines continue to be authorized for primary series administration in individuals six months of age and older.

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