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WASHINGTON, Oct 12: The US Food and Drug Administration (FDA) amended Wednesday the emergency use authorizations (EUAs) of the Moderna and Pfizer Bivalent COVID-19 vaccines “to authorize their use as a single booster dose in younger age groups”. The FDA said in a statement that the Moderna COVID-19 Vaccine, Bivalent is “authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age”. As for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, it noted it is “authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age”.
Director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks said in this regard “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,” he added. “We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible”.
He stressed that “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”. According to the FDA, with today’s authorization, the monovalent Pfizer COVID-19 Vaccine “is no longer authorized as a booster dose for individuals five through 11 years of age”. It indicated that both the Moderna and Pfizer COVID-19 vaccines “continue to be authorized for primary series administration in individuals six months of age and older” (KUNA)