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The companies plan to request an emergency use authorization in a few weeks.
Pfizer and BioNTech have submitted data to the FDA from the phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.
The companies announced positive topline results from the pivotal trial on Sept. 20, 2021. In the trial, which included 2,268 participants 5 to less than 12 years of age, the vaccine demonstrated a favorable safety profile and elicited antibody responses using a two-dose regimen of 10 μg doses. These results were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to less than 12 years of age.
A formal submission to request emergency use authorization (EUA) of the companies’ COVID-19 vaccine is expected to follow in the coming weeks. Submissions to the European Medicines Agency and other regulatory authorities are also planned.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement.
The companies plan to release data in the fourth quarter of the COVID-19 vaccine in two other populations: children 2 to less than 5 years of age and children 6 months up to 2 years of age.