'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,' the FDA's Dr. Peter Marks said.
) bivalent booster for ages 6-17, expanding access to protection against circulating variants for all but the youngest population.
The BA.4/BA.5 variant-targeting shots still await approval from the Centers for Disease Control and Prevention. Similar to the adult boosters, the kids' boosters have been authorized by the FDA based on pre-clinical data, as existing trials to test the efficacy of the vaccine are underway. The movePhase 2/3 trials were conducted for the original Omicron strain, BA.1, and showed strong protection against that and other circulating strains.
“In addition, we have started a clinical trial to evaluate the adapted vaccine based on the BA.4 and BA.5 subvariants in children six months through 11 years of age aiming to offer all age groups the opportunity to immunize against Omicron variants and subvariants," he said.
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