On Sept. 28, 2021, Pfizer and BioNTech announced they had 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 <12 years of age.

Topline immunogenicity and safety readouts for the other two age cohorts from the trial ﾖ children 2 to <5 years of age and children 6 months to <2 years of age ﾖ were expected as soon as the fourth quarter of this year.