Pfizer seeks USFDA emergency use nod for COVID booster in children aged 5 through 11 years
New York: Pfizer Inc. and BioNTech SE have submitted an application to the U.S. Food and Drug Administration (USFDA) 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 (also referred to as children ages 5 through <12).
The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-µg two-dose primary series, which was authorized under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals.
The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorization in the coming weeks.
Read also: Pfizer to seek USFDA nod for COVID booster for healthy 5- to 11-year-olds
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