The vaccine made by Pfizer and its German partner BioNTech is already authorized for emergency use in anyone 12 and older in the US, Canada, and the European Union.
According to the pharma company, the study will enroll up to 4,500 children at more than 90 clinical sites in the United States, Finland, Poland, and Spain.
Based on safety, tolerability, and the immune response generated by 144 children in a phase I study of the two-dose shot, Pfizer said it will test a dose of 10 micrograms in children between 5 and 11 years of age, and 3 micrograms for the age group of 6 months to 5.
Pfizer spokesperson said the company expects data from 5- to 11-year-olds in September and would likely ask regulators for emergency use authorization later that month. Data for children 2 to 5 years old could arrive soon after that, he said.
It expects to have data from the 6 months to 2 years old age group sometime in October or November.