
Drugmakers Pfizer Inc and BioNTech SE said on Monday that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.
The companies said they plan to soon ask global regulators to authorize the shot for the age group, children for whom no vaccine is currently approved in most of the world. They said they expect to complete their submission of data to the U.S. Food and Drug Administration (FDA) this week.