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Side effects were consistent with 16-25 age group
According to the companies, Pfizer Inc. and BioNTech SE results from a Phase 2/3 trial demonstrated a “favorable safety profile and robust neutralizing antibody responses” in children ages 5 to 11, who were given the Covid vaccine’s two-dose regimen of 10 µg given 21 days apart, compared to the 30-µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were similar to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses.
In this study consisting of 2,268 children, the doses were well tolerated, with side effects being similar to the aforementioned 16 to 25 age group.
Pfizer and BioNTech plan to share these data with the FDA, European Medicines Agency (EMA) and other regulators as soon as possible. For the US, the companies expect to include the data in a near-term submission for emergency use authorization (EUA), as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.
Readouts for the other two remaining age groups—children 2-5 years of age and children 6 months to 2 years of age—are expected to be available in Q4.