(WJW) – Pfizer Inc. and BioNTech SE announced Tuesday they have submitted data to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to 11 years old.
The companies say there were positive topline results.
The trial included 2,268 children from 5 to 11.
The dose is a smaller amount than that given to adults.
Pfizer says the vaccine generates a “robust immune response.”
The companies tested a two-dose regimen of 10 micrograms, which is about a third the dosage used for teens and adults.
The shots were administered three weeks apart.
They said the shots were well tolerated and produced an immune response and side effects comparable to those seen in a study of people ages 16 to 25.
Common side effects for teens and adults include fatigue, headache, muscle pain, chills, fever and nausea, according to the Centers for Disease Control and Prevention.
According to CNBC, the shots could be available in time for Halloween if the FDA spends as much time reviewing the data for that age group as it did for 12- to 15-year-olds.
The study also looked at children as young as 6 months.
Data on kids from 2 to 5 and 6 months to 2-years is expected to be submitted to the FDA in the 4th quarter, according to a report from Pfizer.