Pfizer said Sept. 28 it has submitted data on the effectiveness of its COVID-19 vaccine in children between the ages of 5 and 11 to the FDA.
The submission is not yet a formal application for an emergency use authorization for its shot in the age group, but the drugmaker said that is expected to follow "in the coming weeks."
Some health officials have predicted that a COVID-19 vaccine for kids under 12 could receive authorization by Halloween.
Pfizer's clinical trial for children 5 to 11 included 2,268 children, and the drugmaker used doses of its vaccine one-third of the size of the adult dosage. The vaccine was given in two doses.
Pfizer said the vaccine demonstrated a "favorable safety profile and robust neutralizing antibody responses" in the age group.
Trial results for the vaccine in children as young as 6 months are expected as soon as the fourth quarter of this year, Pfizer said.
Read the full news release here.