April 26, Pfizer Inc. and BioNTech SE submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age.
Data from a Phase 2/3 clinical trial in children aged 5 to 11 years old who received a booster dose about 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-g two-dose primary series, which was approved under EUA for this age group in October 2021, were included in the submission.
According to the results of this trial showed that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine resulted in a significant immune response in this age range, with no additional safety flags.
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