Pfizer submits data seeking FDA approval for its COVID-19 vaccine in children ages 5-11
Pfizer announced Tuesday morning that it has submitted data seeking Food and Drug Administration approval for its COVID-19 vaccine in children ages 5-11.
The FDA is expected to take several weeks to analyze data.
The company announced positive results from a pivotal trial on Sept. 20, 2021. In the trial, which included 2,268 participants 5 to 11 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a smaller two-dose regimen. 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 a larger dose.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.