On Oct. 15, 2021, Pfizer and BioNTech announced they had submitted data supporting the vaccination of children 5 to <12 years of age with COMIRNATY (COVID-19 mRNA vaccine) to the European Medicines Agency for a variation of the Conditional Marketing Authorization in the European Union (EU).

The variation request includes data from a Phase 2/3 study, which enrolled children 6 months to <12 years of age. The 2,268 participants who were 5 to <12 years of age received a 10-ﾵg dose level in a two-dose regimen administered 21 days apart. In the trial, the SARS-CoV-2ﾖneutralizing antibody geometric mean titer was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose.