Pfizer, BioNTech Submit Initial Data on COVID-19 Vaccine in Children

Pfizer and BioNTech have begun sending data to the FDA from a phase 2/3 study evaluating their COVID-19 vaccine in children ages five to 11 years old.

The companies said topline data from the 2,268-participant trial has shown the vaccine demonstrates “a favorable safety profile” and elicits “robust neutralizing antibody responses using a two-dose regimen,” and that the results were “comparable” to those reported previously in people 16 to 25 years old.

The drugmakers plan to submit an FDA Emergency Use Authorization application covering children in the coming weeks and plan to submit the data to the European Medicines Agency and other global regulators.