Pfizer-BioNTech COVID-19 vaccine receives FDA Emergency Use Authorization for children 6 months through 4 years of age.
Pfizer Inc. and BioNTech SE announced the FDA granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age).
The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data.
The EUA is based on data from a Phase II/III randomized, controlled trial that included 4,526 children 6 months through 4 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo.
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